Download background and rationale

LLU Institutional Review Board
Application Materials
“Multiple Risk Factor Analysis of an
Outpatient, Intensive Lifestyle Modification Program”
A. BACKGROUND AND RATIONALE
Summary
This pilot research project seeks to determine the clinical effectiveness of the Loma Linda Lifestyle
Program (LLLP) by analyzing multiple routine measurements and results from routine blood tests
as well as of four additional blood tests specific for this research project.
Background
The majority of the deaths in the United States are lifestyle related. There would be a large
improvement in the health of the public if they were to personally adopt healthy lifestyles.
Numerous studies illustrate the significant impact that lifestyle modifications can make on patients
with lifestyle diseases.
With its Seventh-day Adventist (SDA) heritage, Loma Linda University has long had a special
emphasis on the role of lifestyle in health. In numerous places throughout the United States and the
rest of the world, SDAs have implemented intensive lifestyle modifications programs; many of
which are inpatient. Such programs last about 18 days and have found significant improvements in
systolic blood pressure, weight, treadmill endurance, cholesterol, triglycerides, fasting blood sugar,
diabetic neuropathy and angina.
Whereas these programs achieve impressive short-term clinical results they are often located in
areas that are remote from large population centers and therefore have difficulty with follow-up
support of the patient's new lifestyle. Additionally, the programs tend to be fairy expensive with a
large portion that needs to be covered out-of-pocket by the patients themselves. This tends to
significantly limit the market for such services.
Loma Linda University and Medical Center have a number of lifestyle intervention programs such
as cardiac rehabilitation, the Diabetes Center and several programs offered through the Center for
Health Promotion. However they do not offer the intensive lifestyle, group interventions provided
by the intensive lifestyle modification programs.
The research project here proposed will attempt to determine if an outpatient intensive lifestyle
modification program based at Loma Linda will be able to achieve short-term clinical results.
B. STUDY OBJECTIVES
To assess the clinical effect on indicators of multiple risk factors in subjects of an outpatient,
intensive lifestyle modification program in treatment of lifestyle-related illnesses such as type 2
diabetes, hypertension, obesity and dyslipidemia. The indicators of multiple risk factors include
but are not limited to: weight, blood pressure, endurance on exercise stress test, cholesterol,
chol/HDL, LDL, triglycerides, blood sugars, HgA1C, homocysteine, lipoprotein a and C-reactive
protein.
C. PROCEDURES INVOLVED
The only additional procedure introduced by this research project will be four additional tubes of
blood drawn above and beyond the standard blood tests drawn for the LLLP. These will be
performed at the LLU Medical Center laboratory. Results will also be analyzed from routine data
generated by the LLLP. These include routine blood tests, measurements of vital signs as well as a
modified Bruce protocol exercise stress tests. Lifestyle interventions will be discussed in the
methodology section.
Experimental Portion
The experimental part of the LLLP is that portion which is performed above and beyond the routine
health assessments, blood tests and care provided in the LLLP. Specifically, this will be the four
additional blood tests drawn at the beginning and end of the 15-day program. As venipuncture is
routine in the course of clinical care it cannot be considered an experimental procedure or
treatment. Although the intensive lifestyle modification is what is expected to produce the
measured changes in this study, such modifications are standard care for lifestyle modification
programs.
Statistical Justification
As this is a pilot research project, it will be used to investigate the effect size necessary for a power
calculation so that the number of patients required can be determined for subsequent investigations.
Human subject involvement
All subjects will be humans. All participants in the Loma Linda Lifestyle Program will be assessed
according to their eligibility for the research protocol.
Recruitment
Should the potential subject be found eligible, a trained program staff member in the Center for
Health Promotion will carefully explain to each subject this research protocol and seek consent as
described below.
Consent
Subjects will be provided the attached consent form as well as the California Experimental
Subject’s Bill of Rights. These will be provided on the first day of the 15-day intensive portion of
the Loma Linda Lifestyle Program. The project staff member in the Center for Health Promotion
who explained the research project to the subject will then will then seek consent from the subject
in a manner that assures confidentiality and respects the right of the subject to not participate.
Methodology
The four additional experimental blood tests vials will be added to the standard blood tests for the
Loma Linda Lifestyle Program. These tests will be conducted at the Loma Linda University
Medical Center clinical lab by their trained phlebotomist.
Other data that will be analyzed will be that data routinely generated by the Loma Linda Lifestyle
Program. These data include results from exercise stress tests, daily vital signs (including height,
weight, hip/waist ratio and blood pressure), time or distance spent on daily exercise, finger stick
blood sugars and blood tests (including lipid profile and fasting blood sugars). Included in the
standard blood panel but not expected to change significantly are: electrolytes, kidney and liver
function tests, and uric acid).
Data will be analyzed by using patients as their own paired controls comparing before and after the
15-day program.
As it is expected that the standard care of lifestyle modifications will cause the expected change in
the observed measurements, these modifications are described below.
The LLLP will be based on the campus of Loma Linda University under the administration of the
Center for Health Promotion (CHP). The CHP will be utilized for history and physicals, in-depth
dietetic, exercise and psychological evaluations as well as the exercise stress tests and clinic visits.
Other on-campus facilities will be utilized for other portions of the program. Subjects will also be
transported to several natural settings for exercise using LLU vehicles and appropriately licensed
drivers.
LLLP’s Lifestyle interventions will be those commonly used by preventive care providers. These
include health education, exercise and dietary changes including cooking classes. Physical
therapists and exercise physiologists for the purpose of addressing orthopedic problems affecting
exercise as well as promoting stress reduction will provide additional interventions. These will
include routine stretching activities prior to exercise, application of localized and general hot and
cold water, massage and range-of-motion exercises. Specific therapies will be provided under the
prescription of the program’s medical director.
Measurements of height, weight, hip/waist ratios, blood pressure, CBC, chemistry panel (including
electrolytes, LFTs, TSH and lipid profile), homocysteine, HgbA1Clipoprotein a and C-reactive
protein will be obtained at the initial and final evaluations of subjects in the CHP. Exercise stress
tests will be conducted at the CHP before and after the 15-day intervention.
During the initial evaluation, subjects will meet one-on-one with a dietician for evaluation of the
subjects’ diets. During the 15-day program subjects will receive 36 meals including 8 take-home
meals. All meals will be prepared on-site. Meals will be vegetarian with high-complex
carbohydrate, high-fiber and zero-cholesterol. Caloric intake will not be less than 1200 cal/day.
Dietary fat will be approximately 25% with emphasis on mono-unsaturated fats. Subjects will also
receive 8 lectures on nutrition and will participate in 11 cooking classes. Subjects will also be
provided with a vegetarian cookbook.
Subjects will initially be evaluated regarding their exercise history and will be evaluated by a team
of physical therapists and exercise physiologists. Preventive Care faculty and students will perform
an exercise stress test prior to an at the end of the 15-day program. This will assess exercise
tolerance as well as screen for cardiac conditions. An exercise prescription of gradually increasing
moderate exercise will be developed for each subject’s specific condition. Subjects will receive
one lecture on exercise. During the 16-day program they will participate in 24 observed exercise
sessions and routine stretching activities associated with exercise.
Subjects will receive physical therapy to assist with orthopedic conditions (e.g. arthritis), to assist
circulation and reduce stress. Therapy will vary between patients according to their specific needs
but may include range-of-motion exercises, application of localized and general hot and cold water,
and massage.
All smoking subjects will be encouraged to quit prior to the start of the 15-day program. Nicotine
replacements and/or buproprion will be prescribed for those subjects needing these. All subjects
will be encouraged to eliminate sources of caffeine. Subjects will also be encouraged to
discontinue alcohol and to reduce cardiac risks by lifestyle changes. They will also receive a
lecture regarding the need for abstinence form harmful substances.
Subjects will be encouraged to drink 6-8 glasses of water a day. They will be provided with ready
access to bottled water and will be provided with sports bottles. They will also receive a health
lecture on the benefits of water consumption.
Stress management will be taught in lecture and practice will be encouraged including adequate rest
and exercise, proper breathing and meditating on and trust in divine help.
During the 15-day program, subjects will be managed clinically under the direction of the medical
director. Clinical interventions will include adjustment of those medications related to the lifestyle
diagnoses. Should a subject need treatment for a medical condition unrelated to the LLLP, they
will be referred to their primary physician.
Nurses will daily monitor the condition of subjects. This will include daily vitals and finger stick
blood sugars two to four times daily if appropriate. Nurses will also be continually available to
subjects while on campus and available by phone when subjects are at home. Should any situation
arise requiring prompt clinical attention, the nurse will be in ready contact with the medical
director.
Medical records of the patients’ evaluations, history and physicals, daily nursing records and final
clinical report will be kept at the Center for Health Promotion. Copies of the final clinical report
will be forwarded to the subjects’ primary care physician.
Finally, the program will attempt to provide an environment conducive to the subjects making
fundamental lifestyle changes. The program staff will seek to develop friendly relationships with
and around the subjects. Music, social interaction, natural settings, recreation, humor and a
spiritual environment will all be used to create a supportive environment for subjects.
D. ALTERNATIVE PROCEDURES
The treatment in this project is not intended to be an alternative to the ongoing care that subjects
will already be receiving through their primary care or specialty physician. Treatment provided
will be in addition to and in cooperation with their treating physicians.
E. DECEPTION
No deception will be needed or utilized in this research project.
F. LITERATURE REVIEW
Wellness programs are a structured intervention focused on achieving wellness in the physical,
psychological or spiritual realm (Watt, Verma, Flynn, 1998). These programs are aimed at helping
patients to improve their quality of life as well as their physical health through the use of exercise,
diet, and/or spirituality. As such, wellness programs may be an effective way of improving the
treatment of chronic illnesses (Watt, Verma, Flynn, 1998).
Various wellness programs are in operation in different settings (Watt, Verma, Flynn, 1998).
Many wellness programs do show that wellness programs improve the quality of life and physical
health. Conrad and Gibbs, 1988 showed that the effects of their wellness program had a positive
impact on health outcomes. The study assessed the impact of health promotion on employee risk
factors, absenteeism, and insurance utilization per site. The results indicated that participants of the
program exhibited reduced blood pressure, decreased serum cholesterol, loss of weight, and
increased smoking cessation rate compared to non-participants.
In another study, Bowne et al, 1984 showed an improvement in the level of cardio-respiratory
fitness from baseline measurements to the one-year follow-up for the participants of the fitness
program at the Southwestern Home Office. The proportion of participants in the combined high
and good categories increased from 16.9% to 39.1%, while the proportion in the low and fair
categories decreased from 56.2% to 33.7%.
Another benefit of wellness program includes increased work productivity as evidenced by a study
by Holzbach, Piserchia, McFadden(in press) examined the effect of comprehensive health
promotion program on “work related attitudes” of employees at Johnson & Johonson. The results
indicated significant positive changes on organizational commitment, surpervision, working
conditions, job competence/security, and pay/benefits for participants of the health promotion
program.
The benefits of wellness programs not only include increasing physical health but also saving
medical cost in the long run. The healthcare expenditures in the United States reached $322 billion
in 1982, or over 10% of the gross national product. (Bowne, 1984). With this rate of increase in
health care costs, economists predict that costs will double every five years at the current rate of
escalation. With the increase of interest in wellness and health by the public and skyrocketing of
health care costs, it makes a good sense to come up with ways to reduce the rising health care costs.
One of the ways that shows a promise of reducing the health care costs is through wellness
programs (Bowne, 1984). Wellness programs that incorporate various aspects of health promotion
such as exercise, diet, and spirituality may be one of the answers to rising health care costs.
Pellitier (1991) pointed out that comprehensive health promotion programs are both health and
cost-efffective. In the last decade, there has been a recognition that the strategy of wellness and
lifestyle modification holds a promise of decreasing health care costs (Bowne et al, 1984).
References
Bowne, D., Russell, M., Morgan, J., Optenberg, S., Clarke, A. (1984) Reduced disability and
health care costs in an industrial fitness program. Journal of Occupational Medicine, 26(11):809816,
Conrad, K., Riedel, J., Gibbs, J. (1988). Executive Summary. Health promotion: A new direction
in health care. Evaluation of four Blue Cross and Blue Shield Plans’ worksite health promotion
programs. Health Services Foundation, June, 1988.
Holzbach, R., Piserchia, P., McFadden, D. (1994). Effort of a comprehensive hea lth promotion
program on employee attitudes. Journal of Occupational Medicine.
Pelletier, K. (1991) A review and analysis of the health and cost-effective outcome studies of
comprehensive health promotion and disease prevention programs. American Journal of Health
Promotion, 5(4): 311-313
Watt, D., Verma, S., Flynn, L. (1998) Wellness programs; a review of the evidence. Canadian
Medical Association, 158(2) 224-230.
G. INVESTIGATIONAL NEW DRUG
No investigational new drug will be used in this research project.
H. APPROVED DRUG
No investigational drug will be used in this research project.
I. INVESTIGATIONAL DEVICE
No investigational device will be used in this research project.