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Translating Science into Action in Community Settings 6-8-12 Special Considerations Shari Barkin, MD, MSHS Marian Wright Edelman Professor of Pediatrics.

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Presentation on theme: "Translating Science into Action in Community Settings 6-8-12 Special Considerations Shari Barkin, MD, MSHS Marian Wright Edelman Professor of Pediatrics."— Presentation transcript:

1 Translating Science into Action in Community Settings 6-8-12 Special Considerations Shari Barkin, MD, MSHS Marian Wright Edelman Professor of Pediatrics Division Director General Pediatrics 1

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 Research bedside → community evidence → 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? 5  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 Community benefits from evidence-based, sustainable program Improved child health outcomes Science benefits from practical research

10 Why: Childhood Obesity Obesity is a growing epidemic among children that impacts health not only in childhood but into adulthood.

11 Childhood Obesity Childhood and Adult Obesity Link In 2010, 18% of children & adolescents ages 6-19 years were obese—up from 5% in 1970 Preschoolers who were ever overweight are 5x more likely to be overweight as adolescents. Overweight adolescents have a 70% risk of becoming overweight or obese adults.

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

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

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) 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 Funders: State of Tennessee; Vanderbilt Institute of Clinical and Translational Research; 2008-2010

16 Salud con la Familia Results: BMI % Change

17 Project 2: Salud America! 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) Funder: Robert Wood Johnson Foundation; 2009-2011

18 Salud America! Results: Use of Recreation Center Survey ResultsUnexposed (n=65)Exposed (n=66) Adult Use (%) Once a month or less66.1534.85 More than once a month33.8565.15 Adult Use With Child (%) Once a month or less75.3837.88 More than once a month24.6262.12

19 Salud America! Results: Use of Recreation Center by Latino families with their children How often parents use the recreation center with their child Unexposed (%)Exposed (%) Everyday1.5% > 1/week13.9%24.2% Once/week7.7%19.7% >1/month1.5%16.7% Once/month4.6%27.2% Never70.8%10.6% p<0.000* Chi-square test

20 Project 3: Coleman Afterschool Program Goal: To see if children in parks-based afterschool programs were more active than children in usual after-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 Program Results: 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 Community Insight: Focus Groups & Interviews Practice & Preparation: 6-month Pilot Full Intervention Trial: 3- year GROW program Oct. – Jun. 2010 Jul. – Dec. 2011 August. 2012 – Dec. 2016 7 years total: Aug. 2010 – Aug. 2017

24 The GROW Program Intervention 300 parent-child dyads* (children ages 3 – 5) Coleman and East Park Community Centers Nutrition & Physical Activity Program Control 300 parent-child dyads (children ages 3 – 5) Thompson Lane and East Libraries Parent Involvement & Literacy Program *300 dyads split into 3 waves of 100 dyads = 50 per community center (further split into multiple session times) Who? Where? What?

25 The Goals of GROW Individual Instill healthy lifestyle changes Improve Body Mass Index (BMI) trajectories Assess influence of genetic risk factors Family View the effects of parental health changes upon children Community Develop social connections among participant families Assess how the program affects center use/program needs Serve as an example of a successful pediatric obesity prevention program to export to other communities Broader Impact

26 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) Formative Research Demographics

27 Child Age, mean (SD)4.69(0.74) Gender, No. (%) Female30(60.0) Male20(40) Absolute BMI, mean (SD)16.39(0.76) Waist circumference (cm)51.94(2.43) Tricep skinfold (mm)14.22(3.61) Race, No. (%) Black26(52) White15(30) Multi/Other9(18) Hispanic or Latino/Latina2(4) Adult Age, mean (SD)35.92(9.36) BMI (kg/m^2), mean (SD)35.39(12.46) Waist (cm), mean (SD)109.13(22.13) Tricep (mm), mean (SD)40.18(13.89) Gender, No. (%) Female48(96) Male2(4) Race/Ethnicity, No. (%) Black28(56) White19(38) Hispanic or Latino/Latina2(4) Multi/Other3(6) Total Household Income, No. (%) $24,999 or less29(58) $25,000 - $34,9994(8) $35,000 - $49,9992(4) $50,000 - $74,9995(10) $75,000 - $199,9999(18) I prefer not to answer1(2) Formative Research Demographics

28 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. Survey QuestionPilot 1 (N=50)Pilot 2 (N=11) Income under $25,000 58.0% (29)72.7% (8) WIC Participation 14.0% (7)36.4% (4) SNAP Participation 50.0% (25)90.9% (10) Addition of federal assistance program participation question Formative Research Recruitment Changes

29 Formative Research Diet Recall Data

30 Formative Research Accelerometry ●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 1 Pate 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. MPA nap sleep VPA LPA Physical activity threshold 12 AM6 AM12 PM6 PM 12 AM

33 Sedentary LPA Number of 15-second Epochs ≤ 4 epochs > 4 epochs 420 (MPA) 842 (VPA) PA threshold values # of counts/15 sec 123456789101112131415 16 Isolated Spurt A single MVPA period ≤ 4 epochs in length with > 4 epochs of non-MVPA before and after it 123456789101112131415 16 Sedentary LPA 420 (MPA) 842 (VPA) Number of 15-second Epochs PA threshold values # of counts/15 sec > 4 epochs Isolated Sustained Activity A single MVPA period > 4 epochs in length with > 4 epochs of non-MVPA before and after it

34 Sedentary LPA Number of 15-second Epochs > 4 epochs ≤ 4 epochs 420 (MPA) 842 (VPA) PA threshold values #of counts/15 sec 123456789101112131415 16 Clustered Sustained Activity An event comprised of a series of MVPA periods that average >4 epochs, where there are no periods ≥ 4 epochs of non-MVPA Clustered Spurt An event comprised of a series of MVPA periods that average ≤4 epochs, where there are no periods ≥4 epochs of non-MVPA 842 (VPA) Sedentary LPA Number of 15-second Epochs ≤ 4 epochs > 4 epochs 420 (MPA) PA threshold values #of counts/15 sec 123456789101112131415 16

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

36 MVPA Category Distribution MVPA Category Distribution as a Percentage of Total MVPA Girls % (SD) Boys % (SD) P-value 1 Isolated Spurt16.9 (4.8)13.8 (2.9) 0.0123 Isolated Sustained Activity 2.6 (1.2)2.0 (0.7)0.0842 Clustered Spurt63.5 (5.5)60.6 (7.7)0.1503 Clustered Sustained Activity 17.1 (7.8)23.6 (8.7) 0.0113 1 two-tailed t-test 62% 20%16% 2%

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 39 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.

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