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RESEARCH PROPOSAL1
FOOD DESERTS, BEHAVIORAL HEALTH AND COMMUNITY VIOLENCE
Prepared by
Lynn C. Todman, PhD, MCP
Research Affiliate, Community Innovators Laboratory (CoLab)
Department of Urban Studies and Planning
Massachusetts Institute of Technology
Cambridge, MA
&
Project Manager, Lakeland Regional Health System
St. Joseph, MI
In Collaboration with
Section of Nutritional Neurosciences
Laboratory of Membrane and Biophysics
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health
Bethesda, MD
&
Department of Public Health, Nutrition & Wellness
School of Health Professions
Andrews University
Berrien Springs, MI
1 This project is being supported by contributions from Barlean’s Inc. (e.g., smoothie emulsion product containing 1500 mg per serving (15 ml) of the omega-3 EPA
and DHA and Superfruit Greens fortified with minerals, vitamins and contains the antioxidant power of 8 servings of fruits and vegetables); Rose Acres Farms
(omega-3 fortified eggs); and Omega Foods (i.e., pasta sauces, salad dressings, and spreads such as mayonnaise and peanut butter). Other in-kind contributions
include staff time from Lakeland Regional Health System; National Institutes of Health; Southwest Michigan Meals on Wheels; and Belovo, Inc.
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Table of Contents
I.
Statement of the Problem
3
II.
Research Question
3
III.
Proposal
3
IV.
Rationale for use of the selected participant population
6
V.
Literature relevant to this proposal
7
VI.
Project activities
11
VII.
Procedures
12
VIII.
Benefits and Risks
18
IX.
Project Staff, Affiliations and Roles
21
X.
References
24
XI.
Appendices
29
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Statement of the Problem
Communities throughout the United States are enduring unprecedented levels of aggression, violence and
other forms of anti-social behaviors among children, adolescents, and young adults. This is evident in
highly-publicized events such as the attacks at Columbine High School (Colorado), Sandy Hook
Elementary School (Connecticut), Horning Middle School (“Slender Man” - Wisconsin), and Reynolds
High School (Oregon). As of this writing, a shooting at a high school in Washington State has claimed the
lives of four children (as well as that of the shooter). There are numerous other less well-publicized acts
of such behavior playing out in schools and communities nationwide.
These behavioral trends have adverse educational (e.g., truancy, suspension, expulsion and drop out) and
carceral (e.g., arrest, detention and incarceration) implications. They also have serious long-term social
and economic implications because poor educational and carceral outcomes undermine employment
prospects in adulthood that, in turn, lead to low incomes and poverty, and economically, socially and
politically distressed communities.
Nationwide, enormous amounts of money, human and other resources have been expended on efforts to
enhance school and community safety. Some efforts have worked; many have not. Hence, the problem
persists. Moreover, it appears to be worsening. One possible approach to addressing the problem of
aggression, violence and other forms of anti-social behaviors among children, adolescents, and young
adults involves changes in diet and nutrition. There is considerable scientific evidence to suggest that poor
dietary and nutritional status has adverse effects on mental health.
Research Question:
Might improved nutrition and exercise be part of the solution to the problem?
The basic and clinical science is increasingly clear: nutrition is an important component of mental health.
While it has long been understood that nutrition and exercise are important determinants of physical
health (e.g., diabetes, hypertension, obesity), by comparison, we are only beginning to understand the
profound impacts of nutrition on mental health. Might that understanding inform efforts to help address
behavioral health problems that are increasingly present in children, adolescents and young adults?
Proposal
We propose to implement a beta test to assess the feasibility of a community-based clinical trial designed
to determine the efficacy of nutritionally-enhanced school breakfast and lunch meals, and nutrition and
physical education programming in positively impacting the oppositional and anti-social behaviors of
students enrolled in an alternative school in Benton Harbor, Michigan. Phase One of a two-phase
initiative, the beta test will be used to develop and refine processes and methods for addressing
administrative, logistical, procedural, legal, contractual, cultural, scientific, political and other variables
that must be managed to ensure success of a Phase Two implementation of a more comprehensive
community-based trial. Ultimately, the aim of the project is to lay the foundation for a progressive,
evidence-based approach to addressing oppositional and anti-social behaviors in children, adolescents and
young adults.
This is a very complex initiative that brings together numerous disciplinary frameworks and professional
perspectives (e.g., urban planning, public health, education, biosciences, nutritional neurosciences,
psychology, psychiatry and supply chain management) to address a “wicked” problem. Wicked problems,
such as high and persistent rates of community violence, are difficult to solve because, among other
things: they are interconnected with other complex problems; information and knowledge about them is
incomplete and often contradictory; their resolution requires the insights, skills, mental frames and other
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attributes of multiple stakeholders; and they have numerous possible causes that are obscure and hard to
discern, and solutions that are not simple or straightforward.
This investigation has its origins in observations by the Principal Investigator (P.I.) of a seemingly strong
association between the location of food deserts2 – i.e., places without ready access to fresh, healthy, and
affordable food – in the city of Chicago, and the geographical distribution of violence in the city. Two
Chicago maps – one showing the distribution of violent crime incidents in Chicago (Map 1) between
January 2014 and January 2015, and another showing the distribution of the city’s food deserts in 2014
(Map 2) – suggest that many of the city’s most violent communities are also food deserts. Undoubtedly,
there are confounding variables. However, similarities in the two maps are striking, merit serious
consideration, and may have significant implications for community violence.
Map 1
Chicago Incidents of Violent Crime:
January 2014-January 2015
Map 2
Chicago Food Deserts: 2015
Source: Chicago Police Department, CLEARMAP
Crime Summary (2015)
Source: USDA Food Deserts Research Atlas
(last updated October 31, 2014)
In addition, this proposed investigation is informed by decades of clinical research – i.e., peer-reviewed
epidemiological, ecological investigations, case-controlled studies, randomized controlled trials and meta
analytic reviews – demonstrating that nutritional interventions with omega-3 highly unsaturated fatty
acids, vitamins and trace-elements may positively improve scores of aggression, violence, mood and
2 Food deserts are defined by the United States Department of Agriculture (USDA) as “…urban neighborhoods and rural towns without ready access to fresh,
healthy, and affordable food. Instead of supermarkets and grocery stores, these communities may have no food access or are served only by fast food restaurants and
convenience stores that offer few healthy, affordable food options.” (The United States Department of Agriculture. “Food Deserts.” Agricultural Marketing Service.
http://apps.ams.usda.gov/fooddeserts/fooddeserts.aspx . (Accessed February 11, 2015).
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conduct disorders, and symptoms of Attention Deficit Hyperactivity Disorder (ADHD) such as an
inability to sit still, listen, follow instructions, and self-monitor.
It is also informed by community opinion. When questioned in a 2012 focus group discussion about the
sources of violence in their neighborhood, a resident of Chicago’s Washington Park – one of the city’s
most violent communities – noted, “…this food is making us crazy.”
In the proposed beta test, students enrolled in The Alternative Education School at Sorter (Sorter) in the
Benton Harbor Area School District (BHAS) will receive nutritionally upgraded breakfasts and lunches
for an 8-week period starting on Monday, April 13, 2015 extending to Friday, June 5, 2015.
The meals will adhere to United States Department of Agriculture (USDA) guidelines for the National
School Lunch and School Breakfast Program (http://www.fns.usda.gov/nslp/national-school-lunchprogram-nslp) and the USDA Dietary Guidelines for Americans
(http://www.health.gov/dietaryguidelines/2015.asp). The meals will provide essential vitamins and
nutrients, specifically omega-3 fatty acids (omega-3), known to be essential for optimal brain health.
The enhanced menus and meal recipes were developed by Janelle Bennett, RD, MS, registered dietitian at
Lakeland Regional Health System (Lakeland), under the guidance of Dr. Sherine Brown-Fraser, PhD,
RD, CPT, Department Chair of Public Health, Nutrition & Wellness, School of Health Professions,
Andrews University (Andrews). Breakfast and lunch menus were first analyzed for nutrient levels using
USDA’s online nutrient analysis database known as Supertracker. Both the original (currently used by the
school) and the updated (new) menu were analyzed to quantify levels of omega-3 (α-Linolenic Acid,
EPA, & DHA), omega-6 (α-Linoleic Acid), and omega 6:3 ratios for each food item within the menu.
Daily, weekly and monthly averages were calculated for each omega fatty acid study variable.
The meals will be prepared under the guidance of Jeff Thomas, Executive Chef at Lakeland with
assistance from Jodie Hardesty, Manager of Nutritional Services at Lakeland. The meals will be
transported from Lakeland facilities to Sorter by Southwest Michigan Meals on Wheels, which specializes
in the transport of prepared foods.
A 10-week (January 21 through April 9, 2015) nutrition and physical education program precedes the
meal intervention (i.e., the nutritionally-enhanced school breakfasts and lunches). The program serves
multiple purposes. It helps build trust between the project staff, and the students, teachers and staff at
Sorter. It provides valuable information and insights that will help ensure that the initiative is
implemented in a manner that is culturally sensitive and relevant. It also provides data critical to the
success of the beta. Significantly, it facilitates the project team understanding of some of the procedural
and logistical challenges associated with working in a severely under-resourced environment.
The program is administered by Jasel McCoy – Program Director of Fitness and Exercise Science, and
Gretchen Krivak – Director of the Didactic Program in Dietetics. Both are faculty in the Department of
Public Health, Nutrition & Wellness at Andrews. Under the supervision of Dr. Brown-Fraser, Ms. McCoy
and Ms. Krivak developed a curriculum that is based on the Michigan Model for Health for K-12
education. (http://www.emc.cmich.edu/EMC_Orchard/michigan-model-for-health). The Michigan Model
for Health is a comprehensive, skills-based health education curriculum that shares the goal of helping
young people live happier and healthier lives. This nationally recognized curriculum is research based,
and aligned to standards. This means teachers who follow the easy-to-use sequential lesson plans are
meeting their instructional requirements, while at the same time building the knowledge and skills
students need to be successful in school and in life. Using a building-block approach to health education,
the Michigan Model for Health™ addresses the major youth health risk behavior at every grade level,
with age-appropriate instructional activities.
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Undergraduate students enrolled in Andrews HLED 412 Community Health and Fitness II and FDNT 422
Community Nutrition II courses also staff the program. It is being implemented at the school twice weekly
for one hour – one hour for middle school students on Wednesday, and one hour for high school students
on Thursday. In the program, students rotate through a series of hands-on activities that expose them to
new concepts and ideas, which teach them the importance of nutrition and physical activity to their wellbeing and development. Baseline information on students’ understanding of nutrition and physical
activity has been collected and will be compared to data collected at the end of the program to determine
program effectiveness in increasing students healthy behaviors and knowledge of nutrition & physical
exercise. The data collected will be entered and coded by Andrews and NIH project staff. It is also
anticipated that the educational programming will result in increased parental and child awareness of the
pending meal intervention initiative and engagement in the initiative once it is launched.
Rationale for use of the selected participant population
People, especially children who reside in food deserts (i.e., places where people have limited access to
foods that are nutrient-rich/calorie balanced, yet ample access to nutritionally-poor/high calorie foods) are
at heightened risk for poor diet and nutrition and, theoretically, the associated behavioral health problems.
This is because those essential vitamins and nutrients (i.e., omega-3, B vitamins) that have been shown to
support mental health are found in foods, such as marine fish, dark leafy greens, fruits, whole grains, lean
meats, nuts, seeds and beans - foods that are not readily available in food deserts. Moreover, “food-like
substances” that are associated with poor behavioral health, such as sugar, preservatives, colorings, trans
fats, are found in fast and other highly processed foods that are amply (and cheaply) available in food
deserts. The relative lack of nutrient-dense/calorie balanced foods, combined with an abundance of
nutritionally-deplete/high calorie foods, creates a problematic cocktail that may be implicated in a range
of behavioral problems that undermine the success of children who live in food deserts. These facts lead
us back to the research question posed earlier: Can improved nutrition be part of the solution to the
problem of aggression, violence and other forms of anti-social behaviors among children, adolescents,
and young adults?
One rationale for the population selected is that they are residents of a food desert. According to the
USDA’s Designated Food Desert Census Tracts, Benton Harbor is located in a food desert (USDA Food
Access Research Atlas).
The second rationale is that the students selected for this project have been identified by the Benton
Harbor Area School (BHAS) District as those with the most problematic behavioral challenges. These
challenges undermine their educational performance, place them at risk for contact with the juvenile
justice systems, and set them up for long-term social and economic disadvantage. Because they live in a
food desert, the food they consume at home, and in their community, is likely to be of poor quality,
leaving them nutritionally impoverished. Moreover, early analysis of the nutritional content of the
breakfasts and lunches served to them at school suggests that their intake of sodium and sugar
substantially exceeds Recommended Daily Allowances (RDAs), and the omega 6:3 ratio is very low and
out of balance. The school meals further place them at risk for nutritional insufficiency and the associated
behavioral and academic problems. It also places them at an increased risk for developing obesity, type-2
diabetes, cancer, heart disease and other chronic aliments later in life.
Children enrolled at Sorter are middle (6th to 8th grade) and high (9th to 12th grade) school students. Their
ages are between 11-18 years. Between September 3, 2013 and March 1, 2014 according to the school’s
2013 Discipline Infraction Summary, a cohort of 92 Sorter students committed more than 625 disciplinary
infractions including being disruptive (111), showing disrespect (106), using profanity/vulgarity (93),
disrupting educational processes (92), fighting (53), truancy (29), destruction of school property (18),
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horseplay (13), and threatening harm to others (12). Other infractions included weapons violations, arson,
aggravated/felonious assault, and larceny/theft.
Among Sorter students, all are members of families that live below the poverty line and all qualify for
free or reduced breakfast and lunch. More than 50% of the students are male. More that 90% are African
American. Some students are under court supervision (e.g., probation). Many have family members who
are incarcerated.
Based on data collected in a 2012-2013 District Needs Assessment that was conducted by teachers and
staff, a disproportionately high number of Sorter students are victims of either child abuse, neglect, have
anger management issues and histories of violence, are depressed or withdrawn, and have been
incarcerated. All had been expelled or had multiple suspensions and have histories of discipline problems.
A large number of Sorter students have mental health diagnoses including mood, conduct and
oppositional defiance disorder.
Literature relevant to this proposal
There is a substantial body of literature linking nutrition to behavioral health in children, adolescents and
young adults.
Within the scientific literature, epidemiological studies have shown associations between increased
aggression, and vitamin and mineral deficiency (Breakey 1997; Gesch et al. 2002). In addition, several
lines of research have confirmed associations between low levels of zinc and/or iron deficiency, and the
presence of externalizing behaviors in childhood (Liu & Raine 2006; Liu 2004). Externalizing behaviors
refer to conduct problems and a range of anti-social behaviors, which are manifested in outward actions
of children reacting negatively to their external environment (Liu 2004). Externalizing behaviors include
aggression, delinquency, and hyperactivity. In addition, there are countless reports confirming the effects
of nutritional deficiencies to global measurements of cognition, including decreased learning ability; low
IQ; and interruptions of regulatory processes, including the sleep-wake cycle and social-emotional
behaviors. For instance, malnutrition at age 3 has been reported linked to lower IQ at age 3 and age 11 in
a longitudinal study in Mauritius (Liu et al. 2003).
Notably, the peak vulnerability to harm from nutritional deficiencies occurs during pregnancy. During the
last trimester of pregnancy, there is a preferential uptake of the omega-3 docosahexaenoic acid or DHA
and Arachidonic acid (AA) across the placenta to the fetus and then post birth via the transfer of human
milk via the mother. Other critical micronutrients (including vitamins and minerals) for the development
of the central nervous system during pregnancy include selenium, zinc, iodine, iron, copper, vitamins A,
C, E, the B-family of vitamins especially B6 and B12, folate, polyphenols and other antioxidants and longchain omega-3 HUFAs. One significant implication emanating from these relationships is the finding that
male children born to nutritionally deprived women during pregnancy, for which the risk is high among
pregnant women in Benton Harbor, have been found to have 2.5 times the average rate of antisocial
personality in adulthood (Neugebauer et al. 1999).
Omega-3 Highly Unsaturated Fatty Acids (HUFAs). About 50 to 60% of the dry weight of an adult brain
is comprised of lipid (i.e. fat), and at least 35% of the lipid content is made up of highly unsaturated fatty
acids (HUFAs). HUFAs are a dietary essential: they cannot be synthesized de novo but must be either
ingested directly from dietary sources or metabolized from essential polyunsaturated fatty acid (PUFA)
precursors (Innis 2008; Haag 2003; Elmadfa & Kornsteiner 2009). These fatty acids are highly
specialized, with very specific metabolic functions and unique biophysical properties. The parent
compounds for the large number of HUFAs are two PUFAs: α-Linolenic acid (ALA) is the precursor for
the omega-3 fatty acids, and linoleic acid (LA) is the precursor for the omega-6 fatty acids.
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Omega-3 fatty acids (ALA) are readily available in vegetable sources and, in particular, can be found in
green leafy vegetables, plants, vegetable oils such as canola (9%), walnut (10%), and flaxseed (57%),
along with nuts and seeds such as flaxseed and walnuts. The richest direct source of Omega-3 fatty acids
(Eicosapentaenoic [EPA] acid and Docosahexaenoic acid [DHA] are fish such as mackerel, salmon,
herring, sardine and other seafood. These are foods not easily accessible in many communities, especially
low-income communities such as Benton Harbor.
Omega-6 fatty acids are the most abundant polyunsaturated fatty acid (PUFA) in the modern American
diet. They play a critical role in brain health. Omega-6 is primarily sourced from commercially available
manufactured foods and vegetable oils such as soybean, corn, and sunflower oil (Blasbalg et al. 2011).
Typical intake of omega-6 PUFAs in American diets is excessive in relation to omega-3 intake and is
thought to be in the region of 12 to 17 grams daily (Rett & Whelan 2011). The modern Western diet has
contributed to an imbalance between omega-3 and omega-6 in the brain, which is thought to negatively
affect a range of significant biological processes.
Omega-3 HUFAs constitute major structural components of neuronal membranes and are essential for
cell signaling and brain function. In addition, they are involved in nerve function, cell division and growth
(Chalon 2006). The omega-3 DHA increases neuronal responses by enhancing the flexibility of cell
membranes and, as a result, improving magnocellular functions (Stein 2001). DHA also fulfills a pivotal
function in serotonergic and dopaminergic function (Zimmer et al. 2000; Block & Edwards 1987). Most
of the accumulation of DHA takes place during prenatal and early postnatal development, which
coincides with synaptic formation (Haag 2003). EPA converts into signaling molecules called
eicosanoids, which are generated by the oxygenation of twenty-carbon essential fatty acids. There are four
families of eicosanoids - thromboxanes, prostaglandins, leukotrienes and resolvins - that derive from
either an omega-6 or omega-3 fatty acids. They possess varying complex functions including
inflammation, immunity and messengers in the central nervous system (Haag 2003; Calder 2006).
Omega-3 fatty acids and Child Development. The Avon Longitudinal Study of Parents and Children
(ALSPAC), which is also known also as Children of the 90s, is a long-term health research project
conducted by Bristol University in the United Kingdom. The project enrolled more than 14,000 pregnant
women in 1991 and 1992, and the health and development of their children has been since followed in
great detail. Dr. Hibbeln (Associate Investigator [AI] on the beta test that is the subject of this IRB
application) and colleagues reported that low levels of maternal seafood intake during pregnancy (i.e.,
less than 340 g per week) was associated with, among other developmental problems, increased risks of
low verbal intelligence quotient (IQ) compared with mothers who consumed adequate amounts of seafood
(i.e., more than 340 g per week). Low maternal seafood intake was also associated with increased risk of
suboptimum outcomes for prosocial behavior and social development scores. In other words, the lower
the intake of seafood during pregnancy, the higher the risk of suboptimum child developmental outcome
(Hibbeln et al. 2007). In contrast, early dietary intervention with the Omega-3, DHA, resulted in
improved problem-solving skills (Willatts et al. 1998). Maternal fish intake during pregnancy and the
duration of breastfeeding was also associated with improved early developmental outcomes (Oken et al.
2008).
Omega-3 HUFA and Delinquent Behaviors. Diets that are inadequate in omega-3 fatty acids are
associated with an elevated risk of mental health disorders including depression, bipolar, schizophrenia,
dyslexia, dementia and attention-deficit hyperactivity disorder (Richardson et al. 2005; Freeman et al.
2006; Jazayeri et al. 2008; Peet & Horrobin 2002; Edwards et al. 1998; Clayton et al. 2009; Martins 2009;
Stoll et al. 1999). A recent meta-analysis by Bloch and Qawasmi evaluated the data from 10 randomized,
placebo-controlled trials in 699 children and confirmed a potential role for omega-3 in reducing clinical
and core symptoms of ADHD, namely inattention, hyperactivity and impulsivity (Bloch & Qawasmi
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2011). Abnormal omega-3 levels have also been found in the erythrocytes of young people with ADHD
(Gow et al. 2013; Young & Maharaj 2004). In relation to conduct disorder and delinquent behavior, Gow
and colleagues reported significant negative associations between low Omega-3 levels in the blood and
scores of callous-unemotional (CU) traits in a small cohort of children/adolescents with symptoms of
ADHD. In other words, the lower the omega-3 status, in particular EPA, the higher the scores of conductdisordered related behaviors. CU traits are a sizeable risk factor for the later development of psychopathy
and anti-social behaviors.
In 2002, Gesch and colleagues conducted a randomized controlled trial to determine whether anti-social
behaviors in 221 incarcerated young offenders could be improved through dietary interventions with
omega-6/3 fatty acids in conjunction with multi-vitamins and minerals. Their findings showed a 37%
reduction in felony violent offenses compared to placebo (Gesch et al. 2002). This was later replicated in
2010 by Zaalberg and colleagues in the Netherlands in a similar prison setting (n = 221) with comparable
results: a 30% reduction in conduct (Zaalberg 2010). The results of both of these trials are very promising
given the intervention is nutritional and not pharmacological, and highlights the need for further
investment in the potential mediating role of nutrition in anti-social behaviors.
Schoenthaler and Bier (2000) investigated the efficacy of vitamin and mineral supplementation in
juvenile delinquency in a randomized, double-blind, placebo-controlled study of 468 children aged 6-12
years. Vitamins and minerals were given daily at 50% of the U.S. recommended daily allowance. Half of
the children received a placebo. The outcome measure was the number of violent and non-violent
delinquent acts as measured by the school’s official disciplinary records. The findings demonstrated a
47% decrease in anti-social behaviors and violent acts including threats/fighting, conduct problems,
defiance, obscene behavior, refusal to engage, being a risk to others, and vandalism in those children
taking the vitamins and minerals compared to the placebo group (Schoenthaler et al. 2000). The same
investigator substantially reduced the sugar content in the diets of 3000 imprisoned juveniles in U.S. by
replacing unhealthy snacks with healthier options and reducing both sugar and refined foods. The findings
over a 12-month period demonstrated a 21% reduction in anti-social behavior, 25% reduction in assaults,
75% reduction in physical restraints by staff and a 100% reduction in suicides (Schoenthaler 1991).
A host of other studies find links between nutritional status and behaviors. For instance, Liu et al. (2004)
found that in a birth cohort of 1795 children who showed signs of malnutrition (i.e., inadequate intake of
vital nutrients and vitamins) at age 3 were more aggressive or hyperactive at age 8 years, had more
externalizing problems at age 11, and had greater conduct disorders and excessive motor activity at age
17 than a comparison group of 1206 children. In 2005, Itomura and colleagues conducted a placebocontrolled, double-blind study of 166 children between the ages of 9-12 and found that girls fed fish oilfortified foods committed fewer acts of aggression as compared to a control group. In the Norwegian
Mother and Child Cohort Study (more than 23,000 women and children), Magnus and colleagues found
that high consumption of junk foods during the first 5 years of life predicted externalizing problems such
as aggression, hyperactivity, or tantrums among children, independent of other confounding factors and of
the childhood diet (Magnus et al. 2006). Moore et al. (2009) found that children who ate confectionary
daily at age 10 years were significantly more likely to have been convicted for violence at age 34 years.
Schoenthaler and colleagues conducted a double-blind experimental design over a 2-year period with a
sample of 276 incarcerated juveniles and found that a reduction in the amount of sugar consumed was
associated with a 48% reduction in anti-social behavior.
Schoenthaler and colleagues also conducted a randomized, controlled, double-blind trial over a 3-month
period with 62 confined youth aged 13 to 17 years and found that the 32 youth who received a vitaminmineral supplementation committed 28% fewer rule infractions than the 30 youth who received a placebo.
Solnick and colleagues surveyed Boston high school students and found that adolescents who drank more
than five cans of sugary soft drinks per week were significantly more likely to have carried a weapon and
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to have been violent with peers, family members, and dates than those who did not (Solnick &
Hemenway 2012). Iribarren et al. (2004) conducted a cross sectional observational cohort study of 3581
urban white and black young adults and found that high dietary intake of DHA omega-3 fatty acid and
consumption of fish rich in n-3 fatty acids may be related to a lower likelihood of high hostility in young
adulthood. Long et al. (2013) conducted a double-blind randomized trial in which four groups of young
adult men, without histories of aggressive or impulsive behavior, received either a placebo,
multivitamins/minerals, DHA (fish oils) or both for 3 months and found that DHA decreased the display
of aggressive behavior and impulsivity. Other studies that focused on adult populations find strong
associations between high intake of linoleic acid (e.g., omega-6 fatty acids found in soy, corn, and canola
oils) and homicide (Hibbeln 2001); low levels of EFAs and impulsivity disorders (Hallahan et al. 2006);
low intake of fish oils, and hostility and aggression (Hamazaki & Hamazaki 2008); high intake of trans
fats and aggression (Golomb 2012); and B vitamins and folate deficits and aggression (Herbison et al.
2012).
In recent decades, there have been radical changes in the American food supply resulting in being replete
with preservatives, artificial chemicals, flavorings, high fructose corn syrup, high intakes of soybean and
corn oils as well as a falling ratio of omega-3 to omega-6. Arguably, the most vulnerable consumers of
these substances are children, especially low-income children. A direct consequence of these changes has
been micronutrient (e.g., zinc, iodine, iron and omega-3 highly unsaturated fatty acids) deficient diets that
are associated with a range of neurodevelopmental disorders such as ADHD and externalizing behavior
problems that include aggression and hyperactivity in children.
Ideally, for healthy brain states, the intake of omega-3 and omega-6 should be 1:1. However, due to a
high intake of processed foods, the children’s diet (comprised of foods eaten both in and outside of
school) likely has elevated levels of pro-inflammatory omega-6 relative to omega-3. In fact, a detailed
nutritional analysis of the current school’s meals reveals an average ratio of 8:1. (See Appendix A for the
results of the nutritional analysis of the baseline Sorter menu.) It is important to note that an intake of
excessive omega-6 can create an imbalance of omega-3 and omega-6 in the brain. The brain requires a
balance of omega-3 and omega-6 for optimal brain health. Table 1 displays the omega 6:3 content of
commonly used oils.
Table 1
Source: Kresser 2015. 3
In consideration of this imbalance, the school breakfasts and lunches provided in this project will include
omega-3 supplementation in the form of a dessert flavored smoothie emulsion (e.g., Barlean’s organic
3 Extracted from http://chriskresser.com/how-too-much-omega-6-and-not-enough-omega-3-is-making-us-sick. Cross-referenced sources cited in The Nutrition Source,
Harvard School of Public Health.
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key lime swirl) plus trace elements, vitamins and minerals (in foods) which work synergistically with
omega-3 to maximize its absorption. The intervention study will occur over an 8-week period from
Monday, April 13, 2015 to Friday June 05, 2015.
Project activities4
See Appendix B for a complete Project Management spreadsheet. Key project activities are listed below.
October – November 2014:
 Analysis of the nutritional content of baseline (i.e. Fall 2014) school breakfast and lunch menu
December 2014 – May 2015:
 Develop, implement, revise, and evaluate nutrition and physical education curriculum
January – March 2015:
 Revise project budget and secure funding
 Launch nutrition and physical education program (January 21)
 Conduct Nutrition and Fitness Education Survey (pre-assessment)
 Develop intervention study (revised) menus to deliver enhanced nutrition including an improved
omega 6:3 ratio (See Appendix C for revised menu.)
 Develop and standardize recipes for intervention study menus (See Appendix D for revised recipes.)
 Draft Standard Operating Procedures (SOP) manual
 Prepare and submit IRB revisions, including changes in aims; start date; duration; menus; recipes;
budget; neuropsychological pre- and post-assessment instruments, nutritional, fitness, behavioral and
process assessments; and project staff
February – March 2015:
 Plan and conduct Parent Information Sessions (February 25; March 11, 25, & 26)
 Obtain parent/guardian consent and student assent (March 23 – 27; April 6-7)
 Screen students for participation (March 26 – 27)
April – June 2015:
 Continue screening of students for participation (April 6-7)
 Gather baseline academic and behavioral information (March 30 - April 9)
 Conclude Nutrition and Fitness Education (April 16)
 Conduct post-assessment Nutrition and Fitness Education Survey (April 16)
 Launch meal intervention study (April 13)
 Administer Menu Acceptability Survey (April 13 – June 5)
 Conduct formative process evaluation (March 16 – June 5)
 Collect, analyze and store Daily Progress Reports (April 13 – June 5)
 24-hour recall training for Andrews faculty and staff (May 18 – 22)
 Conduct 24-Hr Recall and Food Frequency Questionnaire (June 4-5)
 Administer end-point and post neuropsychological assessment instruments (June 8-9)
4 In January 2014, numerous planning meetings commenced with the BHAS Superintendent, Director of Curriculum and Instruction, Food Services, Parent
University, Development; Sorter School Administrator, Student Advocate and Director of Supplemental Instructional Services. Additional planning meetings took
place between Dr. Lynn Todman, and Dr. Joseph Hibbeln and Dr. Rachel Gow of the National Institutes of Health (NIH). In May 2014, Dr. Todman presented the
project to the Benton Harbor School Board and won approval to move forward. In June 2014, Dr. Hibbeln and Dr. Gow visited Benton Harbor to meet Sorter
administrators and students.
12
 Last day of school year (June 10)
June – September 2015:
 Project team will convene to review all of the raw data collected during the beta period
 Analyze and document all survey and assessment findings
 Develop recommendations for Phase 2
October 2015:
 Complete draft of final report
 Distribute final report for comment
 Brief key stakeholders (i.e., students, parents, guardians, teachers, BHAS central administration and
Board of Trustees, Lakeland and other regional entities engaged in population health management) on
findings
November - December 2015:
 Revised and complete final report
 Submit to key stakeholders
Procedures
This proposed beta test seeks to assess the feasibility of executing a community-based clinical trial to
determine the efficacy of nutritionally enhanced school meals, and nutrition and physical education
programming in positively impacting the oppositional and anti-social behaviors of students enrolled in an
alternative school in Benton Harbor, Michigan. The beta test will be used to identify and to develop
processes and methods for addressing administrative, logistical, procedural, legal, contractual, cultural,
scientific, political and other variables that must be managed in the implementation of a full communitybased trial. In addition to assessing the feasibility of a full trial, this beta test will assess the potential of a
community based trial to test a potential hypothesis that nutritionally-enhanced school meals, and
nutrition and physical education may be a part of a solution to the problem of oppositional and anti-social
behaviors among children, adolescents and young adults. This pilot will provide information and data that
may inform the implementation of more robust real-world investigations in the future.
The nutrient content of the breakfasts and lunches served to Sorter students will be enhanced to increase
their intake of essential vitamins, nutrients and omega-3 fatty acids. Changes in behaviors and academic
performance will be assessed by comparing baseline and final measures.
Currently, children at Sorter are provided meals by national food vendor Sodexo-Magic. The meals are
intended to meet the USDA National School Lunch and School Breakfast Programs. However, sample
evaluations of published school menus indicate that these guidelines may not be currently met.
Specifically, a detailed nutritional analysis of the school breakfasts and lunches found that, on any given
day, the meals provide in excess of 100 grams of sugar and 3500 milligrams of sodium. This does not
follow the American Heart Association recommendation of 3 to 4 teaspoons (or not more than 16 grams)
of sugar and the 1500 mg of sodium recommended in the USDA Dietary Guidelines for Americans
(Dietary Guidelines for Americans). While the USDA guidelines do not make specific recommendations
for intakes of omega-3 and omega-6 fats, the menus indicate that the meals are lacking in omega-3 fatty
acids. In fact, the analysis suggests that, on many days, the meals yield a ratio in excess of 20:1 omega-6
to omega-3 loading. To address these nutritional issues, the menus have been modified on the basis of the
nutrient analysis conducted by Registered Dietitians, Janelle Bennett, RD, MS (Lakeland) and Dr. Sherine
Brown-Fraser, PhD, RD, CPT (Andrews).
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The menus will conform to guidelines put forth by the USDA National School Lunch and School
Breakfast Program and the USDA Dietary Guidelines for Americans. Weekly and daily requirements
were met for fruits, vegetables, grains, meat/meat alternatives, and milk. They will also include higher
intakes of omega-3 fats and lower intakes of omega-6 fats. The new menu has been designed to achieve
the ideal 1:1 omega 6:3 ratio. Practically, this has meant a ratio of anywhere from 2:1 to 4:1 which is
significantly lower than the 8:1 ratio in the current menu.
More specifically, the one-month lunch menus were planned to improve nutrition content of the diet,
specifically including more foods with high levels of omega-3 (α-Linolenic Acid) and limiting omega-6
(α-Linoleic Acid) in the diet. Furthermore, the omega 6:3 ratio has been considerably reduced from the
8:1 ratio analyzed in the original school menu to a 3:1 ratio in the newly modified menu. The reduction in
the omega 6:3 ratio will be accomplished, in part, through food swap outs. That is, where possible, menu
items that are familiar to the students (e.g., chicken, veggie pizza) will be prepared with ingredients with
higher omega-3 and lower omega-6 fats. In addition, foods with high omega 6:3 ratios (e.g., corn and
soybean oils) will be swapped for foods with lower omega 6:3 ratios (e.g., flax seeds and omega-3
fortified chicken, eggs and condiments). This approach has been recently used in three federallyadministered clinical trials without adverse effects.
The recipes selected for the menu are a modified compilation of kid-friendly, tasteful, and nutritious
recipes taken from various local and state school standardized recipes. The recipes will also be
standardized to the serving size based on the number of students enrolled in the study.
Breakfast will include a smoothie plus a grain product and a fluid milk per national breakfast
requirements. (See Appendix E for recent USDA Guidance on the use of smoothies in child nutrition
programs.) The breakfast smoothie menus were developed to include a variety of fruits and vegetables
along with an omega-3 supplement called Barlean’s Swirl. The two-month menu has select smoothies for
each day of the week (see recipes). Each smoothie will have 1400-1500 mg of EPA/DHA, which are
values of omega-3s previously shown to demonstrate improvements in externalizing and internalizing
behavior problems.
In addition, the children will be provided with the equivalent of 1 tablespoon per day (each serving
contains 1500 mg of omega-3 EPA and DHA) of supplemental omega-3 fats in the form of Barlean’s
Citrus Sorbet Omega Swirl or 4 teaspoons of the Barlean’s Mango-Peach Swirl or Piña Colada Swirl
(providing 1440 mg of omega-3 EPA and DHA), which will be added to a breakfast smoothie that will
comprise fresh fruits and a greens supplement. All omega-3 fatty acids provided will be within FDA
Generally Recognized as Safe (GRAS) limits of 3 g/d."
The revised menu will not only improve the balance of omega 6:3 ratios, but will also substantially reduce
(and, where possible, eliminate) the following: industrially produced seed oils including soybean oils,
fried foods, trans-fats; artificial food additives, preservatives and chemicals; added sugars and sodium;
highly processed foods; and foods containing high fructose corn syrup.
Cycle Menu Manager Software will be used to modify recipe yield to adjust serving sizes. This software
is also capable of providing standardized recipes, options to enter new recipes, basic nutrient values
(%DV), along with generating a shopping list based on recipes selected. Cycle Menu Manager will be
accessed through Lakeland HealthCare’s Gordon’s Food Service Management computer system.
In order to ensure the integrity of the intervention study, all meals will be prepared in kitchens managed
by Lakeland – Hanson Hospice Center – under the guidance of Executive Chef Jeff Thomas with
assistance from Manager of Nutrition Services, Jodie Hardesty. The meals will be transported daily in
Cambros (i.e., a company that manufactures insulated boxes used for food transport) by Southwest
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Michigan Meals on Wheels. To ensure food safety and palatability, a food time and temperature form will
be completed for each meal. The form will document: the time the food is picked up at the kitchen; the
temperature the food is when picked up; and the temperature of the food when it arrives at the school. It
will also be used to generate feedback on the meals and to refine the menus by revising, eliminating or
adding menu items based on comments. (See Appendix F for Sample Time and Temperature form.)
Data collection and analysis. Process and outcome evaluation data will be collected throughout the
duration of the beta test.
Process Evaluation. The main purpose of this beta test is to assess the feasibility of a community-based
clinical trial designed to determine the efficacy of nutritionally enhanced school breakfast and lunch
meals, and nutrition and physical education programming in positively impacting oppositional and antisocial behaviors of students enrolled in an alternative school in Benton Harbor, Michigan. This beta will
be used to develop and refine processes and methods for addressing administrative, logistical, procedural,
legal, contractual, cultural, scientific, and political and other variables that must be managed to ensure the
success of a later, more comprehensive, community-based trial. Thus, a critical component of this beta is
a formative process evaluation.
Throughout the lifecycle of the beta, the project team will evaluate the effectiveness of the many
processes and procedures required to successfully execute the objectives of this beta study. Formative
evaluation of program activities will provide the project team with data that can be used to make program
improvements or adjustments. The process evaluation will address questions such as: What unforeseen
problems, glitches, complications were encountered in executing the initiative? How might they be
overcome in a full-scale initiative? What fortuitous events took place that enhanced the initiative? How
might they be replicated in a full-scale initiative?
The project team will use Lean methodology to measure, assess, and improve the end-to-end process. The
Value Stream Map will be utilized to document, analyze and improve the flow of information, materials,
services, people, and the execution of the numerous activities required to complete the feasibility
study. A Value Stream Map (i.e., end-to-end process map) will be used to take into account not only the
activities and steps of the process, but the management and information of the multiple systems that
support the basic process.
Value Stream Mapping is a paper and pencil tool that assists in the visualization and understanding of the
flow of all inputs through a very complex, multi-layer process. Value Stream Mapping is typically used in
process assessment and evaluation in the following four ways: 1) It gathers and displays a far broader
range of information than a typical process map. 2) It tends to be at a higher level than many process
maps. 3) It tends to be used at a broader level, i.e. from receiving of recipe ingredients to consumption of
food to daily evaluation. 4) It tends to be used to identify where to focus future projects, subprojects,
and/or kaizen events.
In addition, the project team will conduct twice-monthly self-assessments to evaluate fidelity to the
original project plan, and to ensure that changes are made with a clear intent; and brief surveys
administered to students, parents, teachers, and staff at approximately weeks 3 and 9 to assess their levels
of engagement and canvass their observations about the project. (See Appendix G for Process Evaluation
Survey questions.)
Outcome Evaluation. There are six elements of the outcome evaluation. They include the following.
1. School-administered Daily Progress Report (DPR): The DPR tracks student behaviors and academic
performance. Teachers and staff will complete DPRs each day for every student in the school.
Students may receive scores ranging from 1 (Needs Improvement) to 4 (Excellent) on a range of
15
indicators including classwork, homework, adherence to class rules and directions, being respectful,
and overall behavior. De-identified raw data (i.e., teachers’ and staffs’ completed forms) will be
collected from the school on a weekly basis, transported by hand to Cali Gregory, Operational
Excellence and Business Transformation Consultant at Lakeland, who will analyze the data to
determine if there are any changes in student behaviors and/or academic performance over the course
of the beta. A request will be made to access historical data to enable comparisons between student
behaviors and academic performance during the time (preceding the meal intervention) of the
nutrition and physical education programming (i.e., January 21 through April 5), and student
behaviors and academic performance during the period of the meal intervention (i.e., April 13 through
June 5). Copies of the raw data will also be stored in a secure place at Lakeland. (See Appendix H for
DPR forms.)
2. Current and historical data will also be collected on student tardiness, attendance, suspensions and
expulsions.
3. Menu Acceptability Survey: Encouraging children and teens to enjoy nutritious foods early in life is a
vital step to a lifetime of making healthy, smart choices. Over time, food preferences may change and
leaning about what students enjoy or dislike on school menus can be beneficial.
When modifying any menu to determine preferences, it is important to implement a menu
acceptability survey to understand specific food preferences and aversions; this will help to identify
any shifts in preferences over a given period of time. The reasons for using a menu acceptability
survey are numerous. A few worth noting include the following.
• Children/teens taste preferences change and mature over time (what is enjoyed one month or day,
may not be liked later on).
• Children/teens can be picky eaters and we can’t assume that they will like everything that we
offer. Surveys can help to identify meals that they like and dislike.
• Can allow for making healthy changes to menus at minimum cost.
The Menu Acceptability Survey developed by Dr. Brown-Fraser and colleagues will determine
preferences in appearance, taste, aroma, texture, temperature and overall acceptability. Students will
fill out the Menu Acceptability Form daily, for the purpose of assessing whether or not the students
like the meals, how they might be reformulated to increase acceptability, and to ensure that they eat
the enhanced meals.
During the beta, the survey will be administered at the following frequency: three times per week
(Monday, Wednesday, Friday) in April and two times per week (Tuesday and Thursday) in May and
June. Shannon Carlock will collect these data and will supervise the volunteers who will distribute the
surveys to the students. Ms. Carlock will give the collected data to Cali Gregory for storage in a
locked cabinet in her office and for distribution to Dr. Brown-Fraser and Ms. Janelle Bennett who
will do the analysis. (See Appendix I for Menu Acceptability Survey.)
4. Nutrition and Physical Activity Education Intervention & Survey: A 10-week educational curriculum
and weekly lesson plans (based on the curriculum) were co-developed by Andrews’ faculty and
students. In an effort to determine and quantify the outcomes of the intervention, a 20-question preand post-survey (questionnaire) was developed and will be administered to participating Sorter
students at the beginning and at the end of both the pilot and main study. In addition, a pre-and postphysical activity assessment (test) will be conducted to determine fitness levels of the students at the
beginning and at the end of both the pilot and beta as well. These data will be entered and analyzed by
Dr. Brown Fraser, Ms. McCoy and Ms. Krivak and coded by NIH. (See Appendix J for Nutrition and
Fitness Surveys.)
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5. A statistical analysis will be conducted of pre- and post- mood and behavior scores on selected scales.
The neuropsychological assessment will be administered in March and June, and will include the
following instruments:
i. Kaufman Brief Intelligence Test (K-BIT) assesses verbal and nonverbal ability;
ii. Conners Parent and Teacher Rating Scales (CPRS-R and CTRS-R) (administered to parents and
teachers) measures changes in symptoms such as inattentive, restless, impulsive and hyperactive
behaviors;
iii. Inventory of Callous and Unemotional Traits which measures changes in conduct-disorder related
behaviors, i.e. callousness, uncaring, and unemotional traits;
iv. Antisocial Process Screening Device assesses callous-unemotional traits, narcissism and
impulsivity;
v. Reactive and Proactive Questionnaire (RPQ) assesses proactive and reactive aggression;
vi. Strengths and Difficulties Questionnaire (SDQ) assesses emotional symptoms, conduct problems,
hyperactivity/inattention, peer relationship problems, and pro-social behavior;
vii. Beck Youth Inventories™ -Second Edition (BYI-II) assesses thoughts, feelings, and behaviors
associated with emotional and social impairment in youth;
viii. Conners Continuous Performance Test 3rd Edition™ (Conners CPT 3™) assesses
inattentiveness, impulsivity, sustained attention, and vigilance.
(See Appendix K for a detailed list of the neuropsychological assessment instruments that will be used.)
The statistical analysis will involve comparisons of scores on the DPRs occurring at the start (baseline)
and end-point of the beta. This will be conducted using the statistical IBM software SPSS package
version 20 employing a one-way repeated measures analysis of variance (ANOVA). The within-subjects
factor will be baseline and end-point time-points t-tests will be conducted across all standardized
behavioral and clinical questionnaires to access changes in scores between baseline and end-point.
Following examination of the distribution of scores by the Kolmogorov-Smirnov test either Pearson
coefficients or Spearmans will be conducted between food frequency and clinical behavioral scores. All
analysis will be conducted using the statistical IBM software SPSS package version 20 using secure
computers on data that has no personally identifiable information for each participant.
The data collected through the neuropsychological assessments will be analyzed by the NIH project staff
once the Reliance Agreement is finalized by NIH. This process will commence once the Lakeland IRB
has issued an approval for the amended protocol.
Additional evaluative tools include two types of Dietary Intake Assessments – 24 Recall and Food
Frequency Questionnaire. Assessing nutrient intake provides a detailed account of a person’s dietary
practices, which often includes an interview about recent food intake (i.e. 24hr Recall) and a survey of
usual food choices (i.e., FFQ). The 24-hour Recall is a guided interview in which the foods and beverages
consumed in a 24-hr period are described in detail. Results can be obtained quickly and method is
relativity easy to conduct, yet it’s reliant on memory and underestimations or overestimations can occur.
(See Appendix L for 24-hour Recall Survey.) The Food Frequency Questionnaire (FFQ) is a written
survey of food consumption during a specific period of time (i.e., 3 months or one year). The FFQ
examines long-term food intake, and is typically inexpensive to administer, however it relies on memory
and typically includes common foods only1. For this project, a computer assisted 24-hr recall interview
and a FFQ will be administered to Sorter Students by Andrews University faculty. The specific FFQ used
will be the Diet History Questionnaire II (DHQ) used and validated by National Health and Nutrition
Examination Survey (NHANES). Dr. Diane M. DellaValle will train Andrews’ faculty on the computer
system. (See Appendix M for Food Frequency Survey.)
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Dietary assessments help to detect current or potential nutrition problems, as well as patterns of eating
behavior (Rolfes, Pinna, and Whitney 2011). Furthermore, dietary/nutrient assessments are valuable in
helping to identify populations, sub-groups or individuals who are malnourished or at nutritional risk
(http://ocw.tufts.edu/data/47/534622.pdf).
At the end of the 8-week meal intervention, the project team will collectively review all of the raw data
collected during the beta as a part of cross-checking process.
Dissemination of evaluation and assessment findings. The results of the process and outcome evaluations
will be shared with all key stakeholders of the beta including Sorter school students, parents, guardians,
teachers and staff; other (non-Sorter) students, parents, guardians, teachers in staff in BHAS; the Central
Administration and Board of Directors of BHAS; Lakeland and other regional health entities engaged in
population health management in a presentation to be held in October 2015.
Privacy protections. All data collected from student participants will be de-identified through a coding
system (i.e., Safe Harbor Method) that removes all but three identifiers (i.e., age [11 to 17]; gender [1 =
female, 2 = male 3 = transgender]; and grade) from the data that collected. No other potential identifiers
(e.g., telephone numbers, addresses, social security numbers) will be noted. Such a system will reduce
identity disclosure risk while at the same time provide the data required to meet the goal and objective of
the project. All data will be entered by Cali Gregory into a password protected excel spreadsheet. Only
project staff with human subjects training will have passwords. All data will be stored in a locked cabinet
in the office of Lynn Todman at Lakeland.
Inclusion and Exclusion Criteria. While all children enrolled at Sorter will be offered the opportunity to
have the nutritionally enhanced meals, only those who meet the inclusion and exclusion criteria provide
Informed Assent, and whose parents or guardians sign the Informed Consent form, may participate in the
meal intervention.
The criteria for inclusion in the intervention includes the following:
 Enrolled in the Alternative Education Center at Sorter in the Benton Harbor Area School District
during the winter term of the 2014-2015 academic year
 Has the capacity to provide Informed Assent (i.e., ability to understand the risks, benefits)
 Children aged between 11 and 18
 Ability to provide oral informed assent to participate (i.e., ability to understand the risks, benefits, etc.
of the initiative)
 Provision of written informed consent by parental or legal guardian
 All male, female and transgender students, all ethnic and racial backgrounds, and all incomes will be
included
 No students enrolled in the school will be excluded from the study unless they opt to not participate
or if they meet the criteria for exclusion
The criteria for exclusion from the project includes the following:
 Intellectual or cognitive impairment sufficient to impair capacity to provide oral Informed Assent
 Lack of parent/guardian signature on Informed Consent
 Known or suspected allergies to fish (including shellfish)
 Unstable medical or psychiatric conditions severe enough to impair ability to participate
 IQ lower than 70 by the Kaufman Brief Intelligence test (K-BIT)
 Use of fish oil supplementation in last 3 months
 Major medical problems of concern to the investigators
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Process for obtaining Informed Consent. Dr. Lynn Todman (PI), Dr. Sherine Brown- Fraser (Co-PI) and
Ms. Keesha McKee and Mr. Will Bledsoe (onsite Medical Monitors) will oversee the distribution and
collection of Informed Assent from the students and Informed Consent from parents and guardians. Care
will be taken to ensure that the consent process is culturally sensitive and reflects an understanding of the
historical and sociocultural context of the relationship between communities of color, and medical
personnel and researchers. To that end, the process will be multi-faceted and, to some extent, flexible and
open-ended.
First, it will involve an invitation to parents from school administrators to attend one of four special
meetings on school premises at times that are deemed convenient for them. (See Appendix N for Parent
Invitation flyer & Informed Consent form.) To accommodate all parents/guardian schedules, meetings
will take place before the school day begins, after school has ended, and during after-school, parentteacher meetings. At the meetings, the PI and other project staff will present oral descriptions of the
project and share key project materials such as the menus and menu assessment survey. The presentations
will describe the intent of the project, the research on which it is based, its relationship to the behavioral
and academic issues that present in their children, and the specific project activities that will take place
(i.e., educational programming, foods served, their composition, meal frequency, assessments) as well as
the timeline, and expectations and requirements for their participation. They will also be walked through
the Informed Consent form, allowed to ask questions, and asked to sign if they are willing to have their
children participate. Students will be asked to provide a verbal Informed Assent.
In addition, we expect that a number of parents and guardians will not be able to attend meetings at the
school. In instances where feasible, project staff will contact the parent or guardian by phone to ask if
they may come to their home or some other convenient location to describe the project and request
consent. In other instances, written descriptions of the initiative and the Informed Consent will be sent
home with the students, who will be asked to get their parents’ or guardians’ signatures.
Finally, the project staff will have to be flexible and creative in obtaining Informed Consent given the
challenges of reaching parents and guardians of some of the children enrolled at Sorter. Many work
multiple jobs, have high demands placed on them as single parents, and/or have had bad experiences with
the school system. They are, therefore, likely to be difficult to reach and engage. Extra care and efforts
will have to be employed in such circumstances.
All project participants will be compensated for their participation in beta. Each parent will receive
$100.00 (2 x $50) gift cards for completing pre- and post-neuropsychological assessments. Each student
will receive $50.00 (2 x $25) gift cards for completing the pre- and post- neuropsychological assessments.
Each teacher will receive $50 (2 x $25) gift cards for completing the pre- and post-neuropsychological
assessment.
Benefits and Risks
Participants are likely to experience direct benefits as a result of taking part in this beta test. Such benefits
include: increased education and awareness of the advantages of good nutrition, healthy food choices, and
physical activity; improved nutritional content of school meals; and, possibly, improved behavioral
health, cognition and physical health (e.g., lower the risk of diabetes, obesity, hypertension). They may
also benefit to the extent that the aforementioned health improvements, in turn, enhance their educational
performance and decrease their risk for contact with the juvenile and adult justice systems. It is also
possible that they may not directly benefit from this intervention.
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The potential benefits to the larger community of which the project participants are a part (i.e., the Benton
Harbor community) includes: a better understanding of the effects of nutrition and physical exercise on
behavioral health, physical health and academic performance; increased awareness of the possible
efficacy of nutritional strategies in addressing anti-social behaviors in children and adolescents; and
evidence supporting a potential strategy for the reduction of detention, incarceration, truancy and dropout
rates of some of the most challenged young residents of the community. In the longer term, information
gleaned from this initiative may help inform efforts to enhance community safety.
The potential benefits to society emanate from a beta test that may ultimately inform the creation of an
innovative, evidence-based intervention (demonstrated in a Phase 2 community-based trial) that is part of
a larger portfolio of strategies and tactics employed to address the national epidemic of school-based and
community-based aggression, violence and other forms of anti-social behaviors among children and
adolescents. As such, this beta test may constitute early empirical work that serves as the basis for the
development violence prevention legislation, policy and programs that reflects a better understanding and
appreciation of the social determinants of violence; that helps improve educational and carceral outcomes
of youth in socially disadvantaged communities, improve community/society-wide safety, and increased
social and economic equity.
Risk Management. This beta test involves a nutrition and physical education program that is based on the
Michigan Model for Health and the enhanced menus are in accordance with USDA National School
Lunch and School Breakfast Program and the USDA Dietary Guidelines for Americans. Thus, there is no
more than minimal risk. Although the approach employed in this project was recently used in three
federally-administered clinical trials without adverse effects, some minimal risks might include mild
gastric upset and/or mild allergic reactions. There may also be minimal psychological risks, such as stress
and anxiousness associated with the completing the neuropsychological assessments.
Some risk will be mitigated by erecting protections in response to a health questionnaire that all Sorter
students, including those who elect to participate in the project, must have completed prior to enrolling in
the school. The questionnaire includes questions about known health issues, including allergies. There
may be unexpected risks such as reactions to previously unknown allergens. Three onsite Medical
Monitors – Ms. Keesha McKee, Mr. Will Bledsoe, and Ms. Shannon Carlock – will ensure that
unexpected risks are addressed in accordance to the protocol outlined below.
All risks for potentially Adverse Events (AE) will be monitored and managed by the three Medical
Monitors. Both have undergone Office for Human Research Protections Human Subjects Assurance
Training in the Office of the Assistant Secretary for Health, Office of the Secretary, U.S. Department of
Health and Human Services. In addition, two of the Medical Monitors (McKee and Carlock) have
undergone basic first aid training administered by Lakeland (Heartsaver First Aid). (See Appendix O for
copies of Heartsaver First Aid certification.)
As noted, AE are unlikely, but may include mild gastric and allergic reactions (e.g., respiratory
symptoms, hives or other rash, or other symptoms of food allergies). It is not anticipated that participants
will develop gastric upset or allergic reactions. There may also be expressions of foreign tastes and food
textures as the children are exposed to foods that are less heavily salted and sweetened, or to a range of
fruits, vegetables, whole grains, nuts, legumes, and other foods with which they may be unfamiliar.
An AE that occurs at school and is not deemed serious by at least one of three onsite Medical Monitors
and the PI, but is possibly related to participation in the beta, will be reported by the PI and at least one of
the Medical Monitors to the IRB Chair by phone within 5 working days after the PI first learns of the
event. In addition, the parents and guardians of the students who participate in the pilot will have the PI’s
contact information (on the copy of the consent form that they will have signed) and will be encouraged
20
to report to the PI any non-serious AE that may be related to the beta, but that occurs outside of school
hours. The PI and at least one of the Medical Monitors will also report that AE to the IRB Chair by phone
within 5 working days after first learning of such an event. In both instances a non serious AE – on that
occurs on school premises and one the occurs off school premises – the PI will also provide a written
report to the IRB Chair within 10 working days of learning about the event.
An AE that occurs at the school and is deemed serious (e.g., a severe allergic reaction) by at least one of
the Medical Monitors and the PI will result in the participant being escorted to the Lakeland Emergency
Room (ER) by one of the three Medical Monitors. If a serious AE occurs out-of-school hours, the parents
and guardians of the participants, who will have the PI’s contact information, will be advised to contact
the PI and to go immediately to the Lakeland ER. For any serious AE, the PI will contact the IRB Chair
by phone within 24 hours of learning of the event. Within 5 working days, the PI will submit to the IRB
Chair an unbiased, fact-based written report on the event, its relationship to the pilot, and its outcome.
It is critical to note that this study involves a nutrition and physical education program that is based on the
K-12 Michigan Model for Health, and is in accordance with USDA National School Lunch and School
Breakfast Program as well as the USDA Dietary Guidelines for Americans. It is important to note that
the physical education program involves mild levels of physical activity. The nutrition program will
comprise foods that are less heavily salted, sweetened, and processed, and will include a range of fresh
of fruits, vegetables, proteins, whole grains, nuts, and legumes that are essential for good physical and
mental health. Thus, the study involves no more than minimal risk (i.e., mild stomach upset, mild
allergic reactions, and/or some mild stress associated with the filling out the questionnaires). Three
Medical Monitors – Ms. Keesha McKee, Mr. Will Bledsoe and Ms. Shannon Carlock – will ensure that
any unexpected and/or serious reactions are promptly addressed in the same way that any other mild or
serious health-related issue that arises as a result of school-based physical activity or food service would
be addressed: students will be escorted to their primary provider, the Lakeland ER, or Lakeland Walk-in
Clinic, and their care will be paid for according to the normal financial assistance process.
Monitoring. Teachers and staff will monitor participants for any unusual health conditions, including
changes in their health status, through daily observations. Participants will also be instructed to report any
changes to the PI and one of the Medical Monitors, especially if the changes are related to the pilot’s
exclusion criteria. (All teachers and staff will be given a list of the inclusion and exclusion criteria.) Such
changes will be verified by the PI and the Medical Monitor in collaboration with the participants’ primary
care provider. In the event the child does not have a primary care provider, verification will be sought at a
walk-in clinic (e.g., Lakeland Affiliate, Southwestern Medical Clinic in Stevensville, MI).
It is the hope of the project team that the beta serves, not only as the basis of a Phase Two implementation
of a more comprehensive community-based trial, but that it also serves as impetus for discussion in
Benton Harbor and other communities about the impact of diet on behavioral health and on the social and
economic welfare and development of under-resourced communities.
21
Project Staff, Affiliations and Roles
All project staff will be asked to do the following:
Please keep communications with the staff and students of The Alternative Education School at Sorter
positive and respectful. Remember that this is a vulnerable student population where cultural competency
and sensitivity is critical for all interactions. These students are learning and their positive experiences
with you will encourage cooperation and continued interest in the goals of this study. If any questions
arise, please contact Ms. Keesha McKee.
(See Appendix P for copies of all staff resumés and certifications.)
Lynn C. Todman (Lakeland) (PI)
Lynn C. Todman, PhD, MCP is a Project Manager for Lakeland HealthCare and Research Affiliate at
Community Innovators Laboratory (CoLab) at the Massachusetts Institutes of Technology (MIT) in
Cambridge, Massachusetts. Dr. Todman’s role in the project is to provide general project oversight and
management, including IRB development and submission, fundraising, and distillation of policy
implications.
Joseph R Hibbeln (NIH) (Associate Investigator)
Joseph R. Hibbeln, MD, USPHS (United States Public Health Service) is an Acting Chief in the Section
of Nutritional Neurosciences in the Laboratory of Membrane Biochemistry and Biophysics, National
Institute on Alcohol Abuse and Alcoholism at the National Institutes of Health (NIH). Dr. Hibbeln’s roles
are to assist with protocol design and to serve as the senior scientific advisor to help ensure that the
project protocol accurately reflects the nutritional neuroscience.
Sherine Brown-Fraser (Andrews) (Co-PI)
Sherine Brown-Fraser, PhD, RD, CPT, Chair, Department of Public Health, Nutrition, and Wellness,
Associate Professor, School of Health Professions, Andrews University. Dr. Brown-Fraser’s role is to
assist with the IRB application and development of protocol; oversee the nutritional analysis of baseline
and upgraded menus while improving the fatty acid profile; collaborate on menu and recipe design; and
ensure that the pilot is designed and implemented in a manner that is culturally appropriate. She will also
supervise the development and implementation of the project’s physical activity & nutritional education
programming and assessments.
Lakeland Regional Health System
Cali Gregory, NHA, MHA, Operational Excellence and Business Transformation Consultant, Lakeland
HealthCare. Ms. Gregory serves as Project Manager and will provide general oversight of data collection
and documentation.
Janelle Bennett, MS, RD, Clinical Dietitian, Lakeland Healthcare. Ms. Bennett serves as the lead
designer of project menus that meet the National School Lunch Program and School Breakfast Program
requirements, while also improving the fatty acid profile that is specific to this project.
Jeff Thomas, Executive Chef, Lakeland Regional Health System. Mr. Thomas will serve as the
supervisor of meal preparation.
Jodie Hardesty, Manager of Nutritional Services, Lakeland HealthCare. Ms. Hardesty will assist with
meal preparation.
22
NIH
Rachel V. Gow, PhD, post-doctoral researcher in the Section of Nutritional Neurosciences, Laboratory of
Membrane Biochemistry and Biophysics, National Institute on Alcohol Abuse and Alcoholism at the
National Institutes of Health. Dr. Gow has worked with child/adolescent psychiatric groups and
specializes in ADHD. She has researched, written and published in the topic of omega-3 fats and behavior
and assessments of brain function. Dr. Gow’s role in this study will be to assist with the IRB application;
assist in the development and design of the protocol including scientific writing for the background
information/rationale of the project; project-management of the Standard Operating Procedures manual;
supervising general administrative support from the Section team at the NIH; and data analysis.
Sharon Majchrzak-Hong, MS is a research chemist in the Section of Nutritional Neurosciences, NIH.
Ms. Majchrzak-Hong will provide administrative and data management support to Drs. Hibbeln and Gow.
Melanie Lozano, is a student of psychology and research assistant to Dr. Rachel V Gow. Mrs. Lozano’s
role is to assist with administrative work involving the IRB application and to support Dr. Gow with data
analysis.
Andrews University
Jasel McCoy, MS, MBA is an Assistant Professor in the Department of Public Health, Nutrition &
Wellness and the Program Director of Fitness and Exercise Studies. Ms. McCoy will design and deliver
fitness assessments and weekly physical educational programming.
Gretchen Krivak, MS, RD is an Assistant Professor and Director of the Didactic Program in the
Dietetics Office, Department of Public Health & Wellness. Ms. Krivak will design and deliver nutrition
assessments and weekly nutrition educational programming.
The Alternative Education School at Sorter
Will Bledsoe, Director at Sorter. Mr. Bledsoe serves as an onsite Medical Monitor who will observe
student reactions to the foods served. He will also oversee the collection of data on student behavior and
academic performance.
Keesha McKee, Student Advocate and Project Liaison at Sorter. Ms. McKee will provide onsite
supervision of the pilot and serves as an onsite Medical Monitor who will observe student reactions to the
foods served. She will also oversee the collection of data on student behavior and academic performance.
Communications/PR
Mari Pat Varga, President, Varga & Associates, Inc., Ms. Varga serves as the project’s communication
consultant and message strategist.
Jill O’Mahony Stewart, Principal, Stewart Communications, Ltd. Visiting Lecturer, DePaul University,
College of Communication. Ms. Stewart provides communications consulting and media outreach.
Independent
Nataka Moore, PsyD, MA. Core Faculty, Chicago Campus, Adler University. Dr. Moore will conduct
neuropsychological assessments and assist with their analyses.
Teresa Barttrum, PsyD, MA. Dr. Barttrum will assist Dr. Moore in conducting the neuropsychological
assessments and assist with their analyses.
Ruth Shim, MD, MPH, Vice Chair, Education and Faculty Development Department of Psychiatry,
Lenox Hill Hospital, NY. Dr. Shim will assist with process evaluation.
23
Michael R. Hawes, President of Belovo, Inc. Mr. Hawes assists with menu development, most
specifically with the omega-3 fortified foods that are consistent with all USDA and FDA Code of Federal
Regulations for Good Manufacturing Practices. Mr. Hawes also acts as vendor coordinator of food
procurement.
Linda K. Strohl, Executive Director, Meals on Wheels of SW Michigan. Ms. Strohl oversees and advises
on the logistics of transportation for all project meals from Lakeland Medical Center to Sorter.
Diane DellaValle, PhD, Assistant Professor, Dept. of Medicine at Medical University of South Carolina.
Dr. Dellavalle’s role is to provide training of the 24-hour recall assessments.
Blythe Handy, Executive Administrator, Whirlpool Corporation. Ms. Handy provides project
management spreadsheet assistance.
Shannon Carlock, Project Coordinator. Ms. Carlock provides administrative coordination and onsite
project assistance at Sorter. She will also serve as one of the three onsite Medical Monitors.
Volunteers (Whirlpool)
Volunteers will assist with the following: meal set up; distribution of meal assessment surveys;
completing Time and Temperature Forms; distribution of meals; post-meal cleanup; and errands runner as
needed. Volunteers will not require Office of Human Research Protection (OHRP) certification because
the BHAS has its own processes for vetting all district volunteers. (See Appendix Q for Volunteer job
description & BAHS Volunteer program form.)
24
References
Antalis, C.J., L.J. Stevens, M. Campbell, R. Pazdro, K. Ericson, J.R. Burgess. 2006. “Omega-3 fatty acid
status in attention-deficit/hyperactivity disorder.” Prostaglandins, Leukotrienes and Essential Fatty
Acids 75: 299-308.
Blasbalg, T.L., J.R. Hibbeln, C.E. Ramsden, S.F. Majchrzak, R.R. Rawlings. 2011. “Changes in
consumption of omega-3 and omega-6 fatty acids in the United States during the 20th century.” The
American Journal of Clinical Nutrition 93 (May): 950-962. doi: 10.3945/ajcn.110.006643.
Bloch, M.H., A. Qawasmi. 2011. “Omega-3 fatty acid supplementation for the treatment of children with
attention-deficit/hyperactivity disorder symptomatology: systematic review and meta-analysis.”
Journal of the American Academy of Child & Adolescent Psychiatry, 50: 991-1000.
Block, E.R., D. Edwards. 1987. “Effect of plasma membrane fluidity on serotonin transport by
endothelial cells.” The American Journal of Physiology, 253: C672-678.
Breakey, J. 1997. “The role of diet and behavior in childhood.” Journal of Pediatrics and Child Health
33: 190-194.
Calder, P.C. 2006. “n-3 polyunsaturated fatty acids, inflammation, and inflammatory diseases.” The
American Journal of Clinical Nutrition, 83: 1505S-1519S.
Chalon, S. 2006. “Omega-3 fatty acids and monoamine neurotransmission.” Prostglandins, Leukotrienes,
and Essential Fatty Acids 75: 259-269.
Clayton, E.H., T.L. Hanstock, S.J. Hirneth, C.J. Kable, M.L. Garg, P.L. Hazell. 2009. “Reduced mania
and depression in juvenile bipolar disorder associated with long-chain omega-3 polyunsaturated fatty
acid supplementation.” European Journal of Clinical Nutrition 63: 1037-1040.
Edwards, R., M. Peet, J. Shay, D. Horrobin. 1998. “Omega-3 polyunsaturated fatty acid levels in the diet
and in red blood cell membranes of depressed patients.” Journal of Affective Disorders 48: 149-155.
Elmadfa, I., M. Kornsteiner. 2009. “Fats and fatty acid requirements for adults.” Annals of Nutrition &
Metabolism 55: 56-75.
Freeman, M.P., J.R. Hibbeln, K.L. Wisner, J.M. Davis, D. Mischoulon, M. Peet, P.E. Keck, Jr., L.B.
Marangell, A.J. Richardson, J. Lake, A.L. Stoll. 2006. “Omega-3 fatty acids: evidence basis for
treatment and future research in psychiatry.” The Journal of Clinical Psychiatry 67: 1954-1967.
Garland, Malcolm R. and Brian Hallahan. 2006. “Essential Fatty Acids and Their Role in Conditions
Characterized by Impulsivity.” International Review of Psychiatry 18 (2): 99–105.
doi:10.1080/09540260600582009.
Gesch, C. Bernard, Sean M. Hammond, Sarah E. Hampson, Anita Eves, and Martin J. Crowder. 2002.
“Influence of Supplementary Vitamins, Minerals and Essential Fatty Acids on the Antisocial Behavior
of Young Adult Prisoners. Randomized, Placebo-Controlled Trial.” The British Journal of Psychiatry:
The Journal of Mental Science 181 (July): 22–28.
Golomb, Beatrice A., Marcella A. Evans, Halbert L. White, and Joel E. Dimsdale. 2012. “Trans Fat
Consumption and Aggression.” PLoS ONE 7 (3): e32175. doi:10.1371/journal.pone.0032175.
25
Gow, Rachel V., and Joseph R. Hibbeln. 2014. “Omega-3 Fatty Acid and Nutrient Deficits in Adverse
Neurodevelopment and Childhood Behaviors.” Child and Adolescent Psychiatric Clinics of North
America 23 (3): 555–90. doi:10.1016/j.chc.2014.02.002.
Gow, R.V., A. Sumich, F. Vallee-Tourangeau, M.A. Crawford, K. Ghebremeskel, A.A. Bueno, J.R.
Hibbeln, E. Taylor, D.A. Wilson, K. Rubia. 2013. “Omega-3 fatty acids are related to abnormal
emotion processing in adolescent boys with attention deficit hyperactivity disorder.” Prostaglandins,
Leukotrienes, and Essential Fatty Acids, 88: 419-429.
Gow, Rachel V., Frederic Vallee-Tourangeau, Michael A. Crawford, Eric Taylor, Kebreab
Ghebremeskel, Allain A. Bueno, Joseph R. Hibbeln, Alexander Sumich, and Katya Rubia. 2013.
“Omega-3 Fatty Acids Are Inversely Related to Callous and Unemotional Traits in Adolescent Boys
with Attention Deficit Hyperactivity Disorder.” Prostaglandins, Leukotrienes, and Essential Fatty
Acids 88 (6): 411–18. doi:10.1016/j.plefa.2013.03.009.
Haag, M. 2003. “Essential fatty acids and the brain.” Canadian Journal of Psychiatry: Revue Canadienne
de Psychiatrie 48: 195-203.
Hamazaki, Tomito, and Kei Hamazaki. 2008. “Fish oils and aggression or hostility.” Progress in Lipid
Research 47 (4): 221-232. doi:10.1016/j.plipres.2008.02.001
Herbison, Carly E., Siobhan Hickling, Karina L. Allen, Therese A. O’Sullivan, Monique Robinson,
Alexandra P. Bremner, Rae-Chi Huang, Lawrence J. Beilin, Trevor A. Mori, and Wendy H. Oddy.
2012. “Low Intake of B-Vitamins Is Associated with Poor Adolescent Mental Health and Behavior.”
Preventive Medicine 55 (6): 634–38. doi:10.1016/j.ypmed.2012.09.014.
Hibbeln, Joseph R. 2000. “Seafood Consumption and Homicide Mortality.” In World Review of Nutrition
and Dietetics, edited by T. Hamazaki and H. Okuyama, 88:41–46. Basel: KARGER.
http://www.karger.com/doi/10.1159/000059747.
———. 2007. “From Homicide to Happiness--a Commentary on Omega-3 Fatty Acids in Human
Society. Cleave Award Lecture.” Nutrition and Health 19 (1-2): 9–19.
Hibbeln, J.R., J.M. Davis, C. Steer, P. Emmett, I. Rogers, C. Williams, J. Golding. 2007. “Maternal
seafood consumption in pregnancy and neurodevelopment outcomes in childhood (ALSPAC Study):
an observational cohort study.” Lancet, 369: 578-585.
Hibbeln, Joseph R., Levi R. G. Nieminen, and William E. M. Lands. 2004. “Increasing Homicide Rates
and Linoleic Acid Consumption among Five Western Countries, 1961-2000.” Lipids 39 (12): 1207–
13.
Innis, S.M. 2008. “Dietary omega 3 fatty acids and the developing brain.” Brain Research, 1237: 35-43.
Iribarren, C., J. H. Markovitz, D. R. Jacobs, P. J. Schreiner, M. Daviglus, and J. R. Hibbeln. 2004.
“Dietary Intake of N-3, N-6 Fatty Acids and Fish: Relationship with Hostility in Young Adults—the
CARDIA Study.” European Journal of Clinical Nutrition 58 (1): 24–31. doi:10.1038/sj.ejcn.1601739.
Jazayeri, S., M. Tehrani-Doost, S.A. Keshavarz, M. Hosseini, A. Djazayery, H. Amini, M. Jalali, M. Peet.
2008. “Comparison of therapeutic effects of omega-3 fatty acid eicosapentaenoic acid and fluoxetine,
separately and in combination, in major depressive disorder.” The Australian and New Zealand
Journal of Psychiatry 42: 192-198.
26
Kresser, C. 2015. How too much omega-6 and not enough omega-3 is making us sick?
http://chriskresser.com/how-too-much-omega-6-and-not-enough-omega-3-is-making-us-sick
Liu, Jianghong. 2004. “Childhood Externalizing Behavior: Theory and Implications.” Journal of Child
and Adolescent Psychiatric Nursing 17 (3): 93–103.
Liu, J., A. Raine. 2006. “The effect of childhood malnutrition on externalizing behavior.” Current
Opinion in Pediatrics 18: 565-570.
Liu, Jianghong, Adrian Raine, Peter H. Venables, and Sarnoff A. Mednick. 2004. “Malnutrition at Age 3
Years and Externalizing Behavior Problems at Ages 8, 11, and 17 Years.” The American Journal of
Psychiatry 161 (11): 2005–13. doi:10.1176/appi.ajp.161.11.2005.
Long, S.J., D. Benton. 2013. “A double-blind trial of the effect of docosahexaenoic acid and vitamin and
mineral supplementation on aggression, impulsivity, and stress.” Human Psychopharmacology:
Clinical and Experimental, 28: 238-247.
Magnus, Per, Lorentz M. Irgens, Kjell Haug, Wenche Nystad, Rolv Skjærven, and Camilla Stoltenberg.
2006. “Cohort Profile: The Norwegian Mother and Child Cohort Study (MoBa).” International
Journal of Epidemiology 35 (5): 1146–50. doi:10.1093/ije/dyl170.
Martins, J.G. 2009. “EPA but not DHA appears to be responsible for the efficacy of omega-3 long chain
polyunsaturated fatty acid supplementation in depression: Evidence from a meta-analysis of
randomized controlled trials.” Journal of the American College of Nutrition 28: 525-542.
Moore, Simon C., Lisa M. Carter, and Stephanie van Goozen. 2009. “Confectionery Consumption in
Childhood and Adult Violence.” The British Journal of Psychiatry 195 (4): 366–67.
doi:10.1192/bjp.bp.108.061820.
Neugebauer, R., H. W. Hoek, and E. Susser. 1999. “Prenatal Exposure to Wartime Famine and
Development of Antisocial Personality Disorder in Early Adulthood.” JAMA 282 (5): 455–62.
Oken, E., M.L. Osterdal, M.W. Gillman, V.K. Knudsen, T.I. Halldorsson, M. Strom, D.C. Bellinger, M.
Hadders-Algra, K.F. Michaelsen, and S.F. Olsen. 2008. “Associations of maternal fish intake during
pregnancy and breastfeeding duration with attainment of developmental milestones in early childhood:
a study from the Danish National Birth Cohort.” The American Journal of Clinical Nutrition 88: 789796.
Peet, M., D.F. Horrobin. 2002. “A dose-ranging study of the effects of ethyl-eicosapentaenoate in patients
with ongoing depression despite apparently adequate treatment with standard drugs.” General
Psychiatry 59: 913-919.
Raine, Adrian, Jill Portnoy, Jianghong Liu, Tashneem Mahoomed, and Joseph R. Hibbeln. 2014.
“Reduction in Behavior Problems with Omega-3 Supplementation in Children Aged 8-16 Years: A
Randomized, Double-Blind, Placebo-Controlled, Stratified, Parallel-Group Trial.” Journal of Child
Psychology and Psychiatry, and Allied Disciplines, August. doi:10.1111/jcpp.12314.
Rett, B.S., J. Whelan. 2011. “Increasing dietary linoleic acid does not increase tissue arachidonic acid
content in adults consuming Western-type diets: a systematic review.” Nutrition & Metabolism 8: 36.
27
Richardson, A.J., P. Montgomery. 2005. “The Oxford-Durham study: a randomized, controlled trial of
dietary supplementation with fatty acids in children with developmental coordination disorder.”
Pediatrics 115: 1360-1366.
Rolfes, Sharon Rady, Kathryn Pinna, and Ellie Whitney. 2011. Understanding Normal and Clinical
Nutrition. 9th edition. Australia; United States: Cengage Learning. 576-577.
Schoenthaler, Stephen J. 1983a. “Diet and Crime: An Empirical Examination of the Value of Nutrition in
the Control and Treatment of Incarcerated Juvenile Offenders.” International Journal of Biosocial
Research 4 (1): 25–39.
———. 1983b. “The Alabama Diet-Behavior Program: An Empirical Evaluation at the Coosa Valley
Regional Detention Center.” International Journal of Biosocial Research 5 (2): 79–87.
———. 1991. “The Northern California diet-behavior program: An empirical evaluation of 3000
incarcerated juveniles in Stanislaus county juvenile hall.” Personality and Individual Differences 12:
337.
Schoenthaler, Stephen J., Stephen Amos, Walter Doraz, Mary-Ann Kelly, George Muedeking, and James
Wakefield, Jr. 1997. “The Effect of Randomized Vitamin-Mineral Supplementation on Violent and
Non-Violent Antisocial Behavior Among Incarcerated Juveniles.” Journal of Nutritional and
Environmental Medicine 7 (4): 343–52.
Schoenthaler, Stephen J., I. D. Bier, K. Young, D. Nichols, and S. Jansenns. 2000. “The Effect of
Vitamin-Mineral Supplementation on the Intelligence of American Schoolchildren: A Randomized,
Double-Blind Placebo-Controlled Trial.” Journal of Alternative and Complementary Medicine (New
York, N.Y.) 6 (1): 19–29.
Solnick, Sara J., and David Hemenway. 2012. “The ‘Twinkie Defense’: The Relationship between
Carbonated Non-Diet Soft Drinks and Violence Perpetration among Boston High School Students.”
Injury Prevention: Journal of the International Society for Child and Adolescent Injury Prevention 18
(4): 259–63. doi:10.1136/injuryprev-2011-040117.
Stein, J. 2001. “The magnocellular theory of developmental dyslexia.” Dyslexia 7: 12-36.
Stevens, L.J., S.S. Zentall, J.L. Deck, M.L. Abate, B.A. Watkins, S.R. Lipp, J.R. Burgess. 1995.
“Essential fatty acid metabolism in boys with attention-deficit hyperactivity disorder.” The American
Journal of Clinical Nutrition 62: 761-768.
Stoll, A.L., W.E. Severus, M.P. Freeman, S. Rueter, H.A. Zboyan, E. Diamond, K.K. Cress, L.B.
Marangell. 1999. “Omega 3 fatty acids in bipolar disorder: a preliminary double-blind, placebocontrolled trial.” General Psychiatry 56: 407-412.
The United States Department of Agriculture. “Food Deserts.” Agricultural Marketing Service.
http://apps.ams.usda.gov/fooddeserts/fooddeserts.aspx (Accessed February 11, 2015).
Willatts, P., J.S. Forsyth, M.K. DiModugno, S. Varma, M. Colvin. 1998. “Effect of long-chain
polyunsaturated fatty acids in infant formula on problem solving at 10 months of age.” Lancet 352:
688-691.
Woods, Margo N. Nutrition Assessment I & II. Tufts University School of Medicine.
http://ocw.tufts.edu/data/47/534622.pdf (Accessed March 3, 2015)
28
Young, G.S., N.J. Maharaj. (2004). “Conquer, blood phospholipid fatty acid analysis of adults with and
without attention deficit/hyperactivity disorder.” Lipids, 39: 117-123.
Zaalberg, A., Henk Nijman, Erik Bulten, Luwe Stroosma, and Cees van der Staak. 2010. “Effects of
Nutritional Supplements on Aggression, Rule-Breaking, and Psychopathology among Young Adult
Prisoners.” Aggressive Behavior 36 (2): 117-26. doi: 10.1002/ab.20335.
Zimmer, L., S. Delion-Vancassel, G. Durand, D. Guilloteau, S. Bodard, J.C. Besnard, S. Chalon. 2000.
“Modification of dopamine neurotransmission in the nucleus accumbens of rats deficient in n-3
polyunsaturated fatty acids.” Journal of Lipid Research 41: 32-40.
29
Appendices
A.
B.
C.
D.
E.
F.
G.
H.
I.
J.
K.
L.
M.
N.
O.
P.
Q.
Results of the baseline Sorter student nutritional analysis
Project management spreadsheet
Revised menu
Revised menu recipes
Memo on recent USDA Guidance on the use of smoothies in child nutrition programs
Sample Time and Temperature form
Process Evaluation Survey
Daily Progress Report (DPR) forms
Menu Acceptability Survey
Nutrition and Fitness Surveys
Neuropsychological assessment instruments
24-hour Recall Survey
Food Frequency Survey
Parent Invitation flyer & Informed Consent form
First Aid certifications
Staff resumés and assurances certifications
Volunteer job description & BAHS volunteer program form