1. RTRN Webinar Thursday, October 22, 2015 Presented by Deborah Taira, ScD RTRN Research Coordinating Center University of Hawaii A Summary of Two Funding Opportunity Announcements (FOAs)

2. Translational Research to Improve Diabetes and Obesity Outcomes (R01) http://grants.nih.gov/grants/guide/pa-files/PA- 13-352.html

3. 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.

4. Award Information Anticipated # of awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Award budget Application budgets are not limited but need to reflect the actual needs of the proposed project. Project period The maximum project period is 5 years.

5. Key Dates Posted DateSeptember 12, 2013 Opening DateJanuary 5, 2014 Letter of IntentNot Applicable Application Due Date(s) Standard dates apply (Feb 5, June 5, Oct 5) Scientific Merit Review Date(s) Standard dates apply Earliest Start Date(s)Standard dates apply Expiration DateJanuary 8, 2017

6. 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.

7. 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.

8. 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.

9. 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.

10. 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?

11. 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.

12. 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).

13. 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/).http://www.pcori.org/research-we-support/pcor/).

14. 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.

15. Merit Review Criteria Significance Investigators Innovation Approach Environment

16. 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: hunterchristine@niddk.nih.govhunterchristine@niddk.nih.gov 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: bl99n@nih.govbl99n@nih.gov Robert Kuczmarski, Ph.D (for obesity trial research) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Telephone: (301) 451-8354 Email: rk191r@nih.govrk191r@nih.gov 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: mh559n@nih.govmh559n@nih.gov

17. 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/PAR- 15-158.html#sthash.8Y1i4Kug.dpuf

18. Award Information Anticipated # of awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Award budget Budgets are limited to direct costs of up to $150,000 per year. Project period The maximum project period is two years.

19. Key Dates Posted Date March 26, 2015 Opening Date June 1, 2015 Letter of Intent Not Applicable Application Due Date(s) March 1, 2016; July 1, 2016; and November 1, 2016 Scientific Merit Review Date(s) February/March 2016, June/July 2016, October/November 2016, and February/March 2017 Earliest Start Date(s) April 2016, July 2016, December 2016, April 2017, July 2017 Expiration Date November 2, 2016

20. Purpose To encourage research applications to develop and pilot test approaches to improve diabetes and obesity prevention and/or treatment in routine healthcare settings.

21. 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.

22. 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.

23. 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.

24. 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):

25. 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. Research Examples (continued):

26. 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: Andrew.bremer@nih.govAndrew.bremer@nih.gov Christine Hunter, Ph.D (for behavioral diabetes research) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Telephone: 301-594-4728 Email: hunterchristine@niddk.nih.govhunterchristine@niddk.nih.gov Robert Kuczmarski, Ph.D. (for obesity) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Telephone: 301-451-8351 Email: KuczmarskiR@EXTRA.NIDDK.NIH.GOVKuczmarskiR@EXTRA.NIDDK.NIH.GOV 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: bl99n@nih.govbl99n@nih.gov

27. QUESTIONS OR COMMENTS? Deborah Taira, ScD Research Coordinating Center dtjuarez@hawaii.edu