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A Summary of Two Funding
Opportunity Announcements (FOAs)
RTRN Webinar
Thursday, October 22, 2015
Presented by Deborah Taira, ScD
RTRN Research Coordinating Center
University of Hawaii
Translational Research to Improve
Diabetes and Obesity Outcomes (R01)
http://grants.nih.gov/grants/guide/pa-files/PA13-352.html
Purpose
• To test practical, sustainable, and cost efficient
adaptations of strategies to prevent and treat
diabetes/obesity.
• Research focused on prevention or reversal of
obesity, prevention of type 2 diabetes, improved care
of type 1 and type 2 diabetes, or prevention or delay
of the complications is encouraged.
• The approaches tested should have the potential for
wide dissemination and implementation outside of
an academic setting such as in routine clinical
practice or communities at risk.
Award Information
Anticipated The number of awards is contingent
# of awards upon NIH appropriations and the
submission of a sufficient number of
meritorious applications.
Award
Application budgets are not limited
budget
but need to reflect the actual needs
of the proposed project.
Project
The maximum project period is 5
period
years.
Key Dates
Posted Date
Opening Date
Letter of Intent
Application Due
Date(s)
Scientific Merit
Review Date(s)
Earliest Start Date(s)
Expiration Date
September 12, 2013
January 5, 2014
Not Applicable
Standard dates apply (Feb
5, June 5, Oct 5)
Standard dates apply
Standard dates apply
January 8, 2017
Background
• Prior studies have shown behavioral lifestyle
interventions, with modest (5-7%) weight loss,
can prevent or delay development of type 2
diabetes in individuals at high risk for the
disorder.
• Large clinical trials have demonstrated that
glycemic control and cardiovascular risk factor
modification can reduce the risk of diabetes
complications.
Background (continued)
• However, achieving weight loss though lifestyle
approaches, although maintenance of weight loss
remains a challenge.
• Efficacious interventions from trials are rarely
translated into widespread practice
• Closing the gap between clinical efficacy research
and adoption and application of these approaches in
community and healthcare settings is a complex
challenge but an important focus of necessary
research to improve the health of the nation.
Areas of Focus
• Testing innovative strategies to promote
implementation of evidence-based health practices
within applied practice/community settings. Examples:
– Achieve more rapid medication intensification in
patients with diabetes,
– Improve adherence to diabetes medications and
blood glucose monitoring
– Increase adherence to screening guidelines such as
screening for gestational diabetes, assessing body
mass index in healthcare practice, or screening high
risk individuals for type 2 diabetes.
Areas of Focus (continued)
• Testing novel adaptation, or translation, of
evidence-based interventions to evaluate
effectiveness within applied practice or
community settings.
• Such evidence-based interventions could include
behavioral lifestyle counseling for weight
management in both children and adults or
diabetes self-management approaches to
improve adherence and tighten glucose control.
Does your research…
• Have applicability to a significant number of at
risk individuals (generalizability)?
• Have the potential to be widely disseminated
(widely adopted) and implemented (put into
practice)?
• Have the potential to be sustained in the
tested setting once the research is concluded?
Implementation and Partnerships
• Encouraged to include an evaluation of the
implementation costs such as resources,
personnel and infrastructure.
• Encouraged to partner with community
organizations, employers, insurers, health care
providers, pharmacies, electronic
medical/health record developers or other
organizations that might provide a venue for
continued dissemination and implementation
if the intervention or approach is proven
effective.
Diverse Populations
• Strongly encouraged to study populations that
reflect the diverse and disadvantaged populations
disproportionately affected by obesity, diabetes and
diabetes complications.
• Validation of culturally appropriate materials such as
translation into another language or some relatively
superficial tailoring of a program is not enough.
• Translation to a different population requires
adaptation be based on meaningful differences
between target population and population
addressed in clinical efficacy research (for example,
research testing adaptations that address unique
barriers or differences in lifestyle and beliefs).
Outcomes
• Study endpoints should be objective diabetes or
obesity related outcomes (e.g., HbA1c, weight change
expressed as BMI, percent weight or body fat decrease,
diabetes risk factor control, screening and prescribing
appropriate medication, patient adherence to effective
therapies, hospitalizations, ER visits, healthcare
utilization, healthcare cost).
• Patient-centered outcomes are encouraged as
additional primary outcomes or secondary outcomes
(http://www.pcori.org/research-we-support/pcor/).
Other Information
• Study design and the accompanying analysis plan
should be linked to the research question.
• The research designs employed do not
necessarily have to be randomized controlled
trials.
• However, researchers should choose the most
rigorous design that is still feasible and relevant
to the questions posed.
• This FOA is intended to support research in
humans and not animals.
Merit Review Criteria
•
•
•
•
•
Significance
Investigators
Innovation
Approach
Environment
Scientific/Research Contacts
•
Christine Hunter, Ph.D (for behavioral research)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: (301) 594-4728
Email: [email protected]
• Barbara Linder, M.D., Ph.D. (for pediatric medical research)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: (301) 594-0021
Email: [email protected]
• Robert Kuczmarski, Ph.D (for obesity trial research)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: (301) 451-8354
Email: [email protected]
• Mary Horlick, M.D. (for pediatric obesity research in clinical settings)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: (301) 594-4726
Email: [email protected]
PAR-15-158 Planning Grants for Pragmatic
Research in Healthcare Settings to Improve
Diabetes and Obesity Prevention and Care
(R34)
http://grants.nih.gov/grants/guide/pa-files/PAR15-158.html#sthash.8Y1i4Kug.dpuf
Award Information
Anticipated The number of awards is contingent
# of awards upon NIH appropriations and the
submission of a sufficient number of
meritorious applications.
Award
Budgets are limited to direct costs of
budget
up to $150,000 per year.
Project
period
The maximum project period is two
years.
Key Dates
Posted Date
Opening Date
Letter of Intent
Application Due
Date(s)
Scientific Merit
Review Date(s)
Earliest Start Date(s)
Expiration Date
March 26, 2015
June 1, 2015
Not Applicable
March 1, 2016; July 1, 2016; and
November 1, 2016
February/March 2016, June/July
2016, October/November 2016,
and February/March 2017
April 2016, July 2016, December
2016, April 2017, July 2017
November 2, 2016
Purpose
To encourage research applications to develop
and pilot test approaches to improve diabetes
and obesity prevention and/or treatment in
routine healthcare settings.
Purpose (continued)
Research applications should be designed to
pilot test practical and potentially sustainable
strategies to improve processes of care and
health outcomes for individuals who are
overweight or obese or at risk for becoming
overweight or obese and/or at risk for or have
type 1 or type 2 diabetes.
Goal
The goal is that, if the pilot study shows
promise, the data from the R34 will be used
to support a full scale trial focused on
improving routine healthcare practice and
informing healthcare policy for the prevention
or management of diabetes and obesity.
Research Examples:
• Studies of innovative models of healthcare delivery
including Patient Centered Medical Homes, shared
medical appointment/group visits, team care
approaches, care coordination, integrated care, shared
decision making, pharmacy based initiatives, or use of
eHealth, mHealth, or health information technology;
• Studies of incentives to improve diabetes prevention,
treatment, and/or outcomes.
• Examples include physician incentives to follow clinical
care guidelines, provide weight loss
therapy/intervention, and achieve target clinical
outcomes in their enrolled patient panels or patient
incentives to adhere to prescribed medications or
follow prevention and treatment recommendations.
Research Examples (continued):
• Studies to improve patient adherence to efficacious
self-management and treatments, such as medications,
blood glucose monitoring, lifestyle change, or other
aspects of diabetes care or prevention. Such
interventions could target patient, provider, and/or
healthcare system provider or some combination.
• Redesign of workflow in physicians’ offices to improve
screening, initial counseling, and follow-up of patients
with diabetes or at risk for diabetes to enhance
adherence to guidelines, promote weight loss, or
improve glycemic control.
Research Examples (continued):
• Studies to test the effectiveness of implementing
recommended strategies (e.g., “Prevention Plus”) for
obesity prevention or treatment in children and
adolescents within primary care settings
• Studies to test strategies for integrating non-primary
care provider delivered lifestyle intervention (e.g.,
interventions delivered remotely by lifestyle coaches or
low-cost commercial weight loss programs) with
primary healthcare delivery, including bi-directional
communication of relevant information to improve
patient outcomes.
Scientific/Research Contacts
• Andrew A. Bremer, M.D., Ph.D (for adult medical diabetes research
National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-827-2555
Email: [email protected]
• Christine Hunter, Ph.D (for behavioral diabetes research)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-4728
Email: [email protected]
• Robert Kuczmarski, Ph.D. (for obesity)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-451-8351
Email: [email protected]
• Barbara Linder, M.D., Ph.D. (for pediatric medical diabetes research)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-0021
Email: [email protected]
QUESTIONS OR COMMENTS?
Deborah Taira, ScD
Research Coordinating Center
[email protected]