Translating Science into Action in Community Settings 6-8-12

1. Translating Science into Action in Community Settings6-8-12 Special Considerations Shari Barkin, MD, MSHS Marian Wright Edelman Professor of Pediatrics Division Director General Pediatrics

2. Translational Research T1: applying discoveries generated during research in the laboratory, and in preclinical studies, to trials and studies in human subjects. T2: enhances the development and adoption of prevention and treatment strategies in clinical and community settings to improve the public’s health.

3. T2 Translational Researchbedside → communityevidence → practice • Identifies community, patient, doctor, & organizational factors that serve as barriers & facilitators to translation; • Develops new intervention & implementation strategies to increase translation, such as quality improvement programs or policies; • Evaluates the impact of strategies to increase translation of healthy behaviors & processes of care.

4. Community Engaged Research Includes: • Community Based Research: • [as opp. to Community Placed Research] Some collaboration with community partners (e.g., an advisory board), but all important decisions made by researchers • Community Based Participatory Research: • A "collaborative approach to research that equitably involves all partners … and recognizes the unique strengths that each brings. CBPR begins with a research topic of importance to the community and has the aim of combining knowledge with action and achieving social change to improve health outcomes and eliminate health disparities." Kellogg Foundation Community Health Scholars Program • Emphasizes meaningful consultation & participation from community stakeholders in all phases of a project • Community Driven Research: • All important decisions made by community representatives or organization

5. Why the increasing emphasis on Community Engaged Research? • In Social Research: • Greater recognition of issues of external validity and the value of collaboration • Community involvement can increase application & its success • Ethical considerations of participant community voice and control • In Health Research: • Need for translational research • US health outcomes are no better than outcomes for other industrialized countries • Even though the US is a leader in biomedical research, there is a gap between this research and practice, and ultimately health outcomes • NIH Roadmap – http://nihroadmap.nih.gov • Long-term plan to strengthen linkages between research and practice and practice and communities • One strategy – community engaged research

6. Added Ethical Concerns in Reviewing CER • Same principals, different level of application • Respect for community, culture, and the individuals who make up that community. Special attention given to communities that have suffered discrimination, marginalization, and exploitation • Beneficence means doing no harm to individuals, community groups, and cultural institutions • Justice means all partners in the research share the benefits, and the work is fair to the whole community, including those not represented by the working coalition

7. Being sensitive to time frames • It is death to a study funded for a year to spend the first six months trying to get IRB approval • Allow activities to start (e.g., needs assessment) before details are ready for later activities (e.g., interventions) • Expedite review of amendments and new studies (under an umbrella) when timing is critical • Invite investigators to committee meetings early in the review process to allow a dialogue with the committee to occur and to avoid repeated deferrals

8. The Nashville Collaborative: A Partnership To Develop and Test Community-based, Family-centered Programs that Measurably Reduce Childhood Obesity • Metro Parks Board approval in May 2008 • Official launch on June 28, 2008 • 7 grants obtained to test programs: • Family-based • Community-centered • Measureable • Sustainable Mr. Paul Widman and Dr. Shari Barkin, Co-Directors

9. I. What: Benefits of Academic–Community Partnership Science benefits from practical research Community benefits from evidence-based, sustainable program Improved childhealth outcomes

10. Why: ChildhoodObesity

11. Childhood Obesity

12. Childhood Obesity Disproportionate Effect on Minorities Of 2-5 year olds:

13. Childhood Obesity Disproportionate Effect on Minorities Of 2-5 year olds: 24-27% 12-15% 4-5%

14. Achievements An Overview of Nashville Collaborative Projects: • Salud con la Familia • Salud America! • Coleman Afterschool Program • Growing Right Onto Wellness (GROW)

15. Project 1: Salud con la Familia (Health with the Family) Funders: State of Tennessee; Vanderbilt Institute of Clinicaland Translational Research; 2008-2010 • Goal: To examine a family-based, community centered intervention to prevent/treat obesity for Latino parent-preschool child pairs. • Enrolled 100 Latino families with preschool-age children in 12 week sessions. • Results: • 41% of Latino preschoolers started overweight • Intervention group was 2x as likely to change their weight category to normal in 3 months

16. Salud con la Familia Results: BMI % Change

17. Project 2: Salud America! Funder: Robert Wood Johnson Foundation; 2009-2011 • Goal: To evaluate the impact of a community engaged research study (Salud con la Familia) on: • Latino family use of a recreation center for routine physical activity (134 families surveyed) one year after specific programming ended. • Metro Parks and Recreation programs and policies for Latino families with young children (89 staff surveyed)

18. Salud America!Results: Use of Recreation Center

19. Salud America!Results: Use of Recreation Center by Latino families with their children

20. Project 3: Coleman Afterschool Program • Goal: To see if children in parks-based afterschool programs were more active than children in usualafter-school programs. • 100 school-age children enrolled • Results: • Saw a 12% increase in activity over 3 months - 10% was in high-intensity activity • Reduced the gender gap – girls in Coleman program more active than control girls Funders: Vanderbilt CTSA and Institute for Obesity and Metabolism; 2010

21. Coleman Afterschool ProgramResults: Percent Change in Physical Activity • Children in parks-based program began ~10% more active than the control group. • After 3 months, they were ~20% more active than the control group.

22. Project 4: GROW Growing Right Onto Wellness (GROW) • Vanderbilt University School of Medicine Department of Pediatrics working with Metro Parks and Recreation was awarded $12 Million to prevent childhood obesity over 7 years. • Develop and test a multi-ethnic, community-based, family-centered healthy lifestyle intervention with 600 families with preschool-age children over three years

23. The GROW Timeline • 7 years total: Aug. 2010 – Aug. 2017 August. 2012 – Dec. 2016 Jul. – Dec. 2011 Oct. – Jun. 2010

24. The GROW Program Who? Where? What? *300 dyads split into 3 waves of 100 dyads = 50 per community center (further split into multiple session times)

25. The Goals of GROW Broader Impact

26. Formative ResearchDemographics • Focus Groups: 6 Parent Groups (N=50); 4 Metro Parks and Recreation Staff Groups (N=17) • Activity Testing: Conducted classes at intervention sites to test parent-child programming • Curriculum Development: Developed materials; involved expert review and cognitive interviews (N=60) • PhotoVoice: Assessed barriers around healthy eating and nutrition (N=6) • Pilot Study: • Tested RCT screening processes and intervention curriculum in the East Park area (N=50) • Updated curriculum and processes and tested with additional group in East Park area (N=11)

27. Formative ResearchDemographics

28. Formative ResearchRecruitment Changes Addition of federal assistance program participation question Target community highly gentrified resulting in participant income ranging from ≤ $14,999 to $100,000-$199,999 New screening tool respectfully determines underserved status through participation in federal assistance programs.

29. Formative ResearchDiet Recall Data

30. Formative ResearchAccelerometry • Baseline data were collected from 45 children 3 to 5 years of age who were participating in a healthy lifestyle pilot study. • Physical activity was assessed using an accelerometer. • Data were analyzed in 15-second epochs. • Validated threshold values were used to derive time spent in sedentary, light, moderate, and vigorous activity.1 1Pate RR, Almeida MJ, McIver KL, Pfeiffer KA, Dowda M. Validation and calibration of an accelerometer in preschool children. Obesity (Silver Spring). 2006;14(11):2000 –2006

31. Demographic and Baseline Results • N=24 girls, 21 boys • Ethnicity: 51% black, 31% white, 13% biracial • 34 normal weight, 11 overweight • Average age: 4.4 (SD 0.7) years • On average, participants wore accelerometers for 23.3 (SD 1.1) hours a day for 6.7 (0.8) days. • Children spent 8.8% (SD 2.2) of their wear time in MVPA. ActiGraph GT3X+ Accelerometer

32. Sample 24-Hour Activity Recording • On average, children completed 90% of their daily MVPA in 11.3 hours (SD 1.3 hours). • Young children are active throughout the majority of their waking hours. Physical activity threshold VPA MPA nap sleep sleep LPA 12 AM 6 AM 12 PM 6 PM 12 AM

33. Isolated Spurt A single MVPA period ≤ 4 epochs in length with > 4 epochs of non-MVPA before and afterit 842 (VPA) ≤ 4 epochs PA threshold values # of counts/15 sec 420 (MPA) Isolated Sustained ActivityA single MVPA period > 4 epochs in length with > 4 epochs of non-MVPA before and after it LPA 842 (VPA) > 4 epochs > 4 epochs > 4 epochs PA threshold values # of counts/15 sec 420 (MPA) Sedentary LPA > 4 epochs Sedentary > 4 epochs Number of 15-second Epochs 1 1 2 2 3 3 4 4 5 5 6 6 7 7 8 8 9 9 10 10 11 11 12 12 13 13 14 14 15 16 15 16 Number of 15-second Epochs

34. Clustered SpurtAn event comprised of a series of MVPA periods that average ≤4 epochs, where there are no periods ≥4 epochs of non-MVPA 842 (VPA) ≤ 4 epochs ≤ 4 epochs PA threshold values #of counts/15 sec 420 (MPA) Clustered Sustained ActivityAn event comprised of a series of MVPA periods that average >4 epochs, where there are no periods ≥ 4 epochs of non-MVPA LPA ≤ 4 epochs Sedentary > 4 epochs > 4 epochs 842 (VPA) > 4 epochs 420 (MPA) PA threshold values #of counts/15 sec LPA Number of 15-second Epochs 1 2 3 4 5 6 7 8 9 11 13 10 12 14 15 16 ≤ 4 epochs Sedentary 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 Number of 15-second Epochs

35. MVPA Category Duration Among Participants Time in MVPA within Activity Block Length of Activity Block

36. MVPA Category Distribution 2% 20% 16% 62%

37. Formative Phase Conclusion • Young children appear to participate in MVPA throughout most of their waking hours in 4 varied patterns: • Isolated spurts • Isolated sustained activity • Clustered spurts • Clustered sustained activity • Children spend the majority of their MVPA in clustered spurts. • Applying these MVPA categories may help inform preschool activity programs and policies to promote developmentally appropriate physical activity for young children.

38. Conclusions • Clinical and Translational Research includes multiple settings • Community settings require additional scientific rigor to test interventions in real-world settings (efficacy and effectiveness) • Findings can directly affect health and research

39. References Ball J, Janyst P. Enacting Research Ethics in Partnerships with Indigenous Communities in Canada: Do it in a good Way”. Journal of Empirical Research on Human Research Ethics 2008 vol.3 (2) 33-52. Canada Tri-Council Working Group on Ethics,Code of Conduct for Research Involving Humans {draft}: Ottawa: Minister of Supply and Services, 1996 Childress JF, Fletcher JC. Respect for autonomy. Hastings Center Report 1994;24(3):34–5. Dickert N and Sugarman J Ethical Considerations of Community Consultation in Research . American Journal of Public Health. 2005 vol 95 no.7 2005. Grignon J, Wong KA, Seifer SD. Ensuring Community-level Research Protections. Proceedings of the 2007 Educational Conference Call Series on Institutional Review Boards and Ethical Issues in Research. Seattle, WA:Community-Campus Partnerships for Health, 2008. Israel A et al. Review of Community-Based Research: Assessing Partnership Approaches to Improve Public Health. Annual Review of Public Health. 1998 19:173-202. Israel B, et al (Eds.). Methods in Community-Based Participatory Research for Health. San Francisco: Jossey-Bass & Co., 2005. Miller B. Autonomy. In: Reich WT, ed.Encyclopedia of Bioethics, Rev. ed. New York: Simon & Schuster MacMillan, 1995:215–20. Minkler M, Wallerstein N (Eds.). Community-Based Participatory Research for Health. San Francisco: Jossey-Bass & Co., 2003 Strand K, et al. Community-Based Research and Higher Education: Principles and Practices. San Francisco: Jossey-Bass & Co., 2003. Weijer, C. Protecting Communities in Research: Philosophical and Pragmatic Challenges Cambridge Quarterly of Healthcare Ethics (1999), 8, 501–513. Cambridge University Press Viswanathan M, Ammerman A, Eng E, Gartlehner G, Lohrk N, Griffith D, Rhodes S, Samuel-Hodge C, Mary S, Lux L, Webb L, Sutton SF, Swinson T, Jackman A, Whitener L, Community-Based participatory Research: Assessing the Evidence Evidence Report Technology Assessment No. 00 AHRQ Publication 04-E022-2 Rockville, MD: Agency for Healthcare Research and Quality. July 2004.