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Translating Science into Action in Community Settings 6 -8 -12 Special Considerations Shari Barkin, 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

Translational Research T 1: applying discoveries generated during research in the laboratory, and in Translational Research T 1: applying discoveries generated during research in the laboratory, and in preclinical studies, to trials and studies in human subjects. T 2: enhances the development and adoption of prevention and treatment strategies in clinical and community settings to improve the public’s health.

T 2 Translational Research bedside → community evidence → practice § Identifies community, patient, T 2 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.

Community Engaged Research Includes: § § § Community Based Research: § [as opp. to 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

Why the increasing emphasis on Community Engaged Research? In Social Research: Greater recognition of 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 Need for translational research In Health Research: NIH Roadmap – http: //nihroadmap. nih. gov 5 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 Long-term plan to strengthen linkages between research and practice and communities One strategy – community engaged research

Added Ethical Concerns in Reviewing CER Same principals, different level of application Respect for 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

Being sensitive to time frames It is death to a study funded for a 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

The Nashville Collaborative: A Partnership To Develop and Test Communitybased, Family-centered Programs that Measurably The Nashville Collaborative: A Partnership To Develop and Test Communitybased, 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

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

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

Childhood Obesity Childhood and Adult Obesity Link • In 2010, 18% of children & 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 5 x more likely to be overweight as adolescents. • Overweight adolescents have a 70% risk of becoming overweight or obese adults.

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

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

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

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

Salud con la Familia Results: BMI % Change Salud con la Familia Results: BMI % Change

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

Salud America! Results: Use of Recreation Center Survey Results Unexposed (n=65) Exposed (n=66) Adult Salud America! Results: Use of Recreation Center Survey Results Unexposed (n=65) Exposed (n=66) Adult Use (%) Once a month or less 66. 15 34. 85 More than once a month 33. 85 65. 15 Adult Use With Child (%) Once a month or less 75. 38 37. 88 More than once a month 24. 62 62. 12

Salud America! Results: Use of Recreation Center by Latino families with their children How Salud America! Results: Use of Recreation Center by Latino families with their children How often parents use the Unexposed (%) Exposed (%) recreation center with their child Everyday 1. 5% > 1/week 13. 9% 24. 2% Once/week 7. 7% 19. 7% >1/month 1. 5% 16. 7% Once/month 4. 6% 27. 2% Never 70. 8% 10. 6% p<0. 000* Chi-square test

Project 3: Coleman Afterschool Program Funders: Vanderbilt CTSA and Institute for Obesity and Metabolism; Project 3: Coleman Afterschool Program Funders: Vanderbilt CTSA and Institute for Obesity and Metabolism; 2010 • 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

Coleman Afterschool Program Results: Percent Change in Physical Activity • Children in parksbased program Coleman Afterschool Program Results: Percent Change in Physical Activity • Children in parksbased program began ~10% more active than the control group. • After 3 months, they were ~20% more active than the control group.

Project 4: GROW Growing Right Onto Wellness (GROW) • Vanderbilt University School of Medicine 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

The GROW Timeline • 7 years total: Aug. 2010 – Aug. 2017 August. 2012 The GROW Timeline • 7 years total: Aug. 2010 – Aug. 2017 August. 2012 – Dec. 2016 Jul. – Dec. 2011 Practice & Preparation: 6 -month Pilot Oct. – Jun. 2010 Community Insight: Focus Groups & Interviews Full Intervention Trial: 3 - year GROW program

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

The Goals of GROW Individual • Instill healthy lifestyle changes • Improve Body Mass 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 Broader Impact Serve as an example of a successful pediatric obesity prevention program to export to other communities

Formative Research Demographics • • • Focus Groups: 6 Parent Groups (N=50); 4 Metro Formative Research Demographics • • • 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) Photo. Voice: 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 Adult Child Age, mean (SD) Female Male 30(60. 0) 20(40) Absolute Formative Research Demographics Adult Child Age, mean (SD) Female Male 30(60. 0) 20(40) Absolute BMI, mean (SD) 16. 39(0. 76) Waist circumference (cm) 51. 94(2. 43) Tricep skinfold (mm) 14. 22(3. 61) 109. 13(22. 13) 40. 18(13. 89) Gender, No. (%) Female Male 48(96) 2(4) Race/Ethnicity, No. (%) Black 28(56) White 19(38) Hispanic or Latino/Latina 2(4) Multi/Other Race, No. (%) Black 35. 39(12. 46) Tricep (mm), mean (SD) Gender, No. (%) BMI (kg/m^2), mean (SD) Waist (cm), mean (SD) 4. 69(0. 74) 35. 92(9. 36) 3(6) Total Household Income, No. (%) 26(52) $24, 999 or less 29(58) 15(30) Multi/Other 9(18) Hispanic or Latino/Latina 2(4) 4(8) $35, 000 - $49, 999 2(4) $50, 000 - $74, 999 5(10) $75, 000 - $199, 999 White $25, 000 - $34, 999 9(18) I prefer not to answer 1(2)

Formative Research Recruitment Changes • Target community highly gentrified resulting in participant income ranging Formative Research Recruitment Changes • 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. Addition of federal assistance program participation question Survey Question Pilot 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)

Formative Research Diet Recall Data Formative Research Diet Recall Data

Formative Research Accelerometry ● ● Baseline data were collected from 45 children 3 to 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, Mc. Iver KL, Pfeiffer KA, Dowda M. Validation and calibration of an accelerometer in preschool children. Obesity (Silver Spring). 2006; 14(11): 2000 – 2006

Demographic and Baseline Results ● N=24 girls, 21 boys ● Ethnicity: 51% black, 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. Acti. Graph GT 3 X+ Accelerometer

Physical activity threshold Sample 24 -Hour Activity Recording ● ● VPA MPA nap sleep Physical activity threshold Sample 24 -Hour Activity Recording ● ● VPA MPA nap sleep LPA 12 AM 6 AM 12 PM 6 PM 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. 12 AM

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

 #of counts/15 sec PA threshold values ≤ 4 epochs 842 (VPA) ≤ 4 #of counts/15 sec PA threshold values ≤ 4 epochs 842 (VPA) ≤ 4 epochs 420 (MPA) LPA Sedentary ≤ 4 epochs > 4 epochs 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 #of counts/15 sec PA threshold values Number of 15 -second Epochs > 4 epochs 842 (VPA) > 4 epochs 420 (MPA) LPA ≤ 4 epochs Sedentary 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 Number of 15 -second Epochs 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 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

MVPA Category Duration Among Participants 12 10 Minutes 8 Time in MVPA within Activity MVPA Category Duration Among Participants 12 10 Minutes 8 Time in MVPA within Activity Block Length of Activity Block 6 9. 1 4 7. 3 2 0. 34 1. 9 0 Isolated Spurt Isolated Sustained Activity 1. 7 3. 0 Clustered Spurt MVPA Category Clustered Sustained Activity

MVPA Category Distribution Average Percent of MVPA 20% 16% 62% 2% MVPA Category Distribution MVPA Category Distribution Average Percent of MVPA 20% 16% 62% 2% MVPA Category Distribution as a Percentage of Total MVPA Girls Boys P-value 1 % (SD) 16. 9 (4. 8) 13. 8 (2. 9) 0. 0123 Isolated Spurt Isolated Sustained 2. 6 (1. 2) 2. 0 (0. 7) 0. 0842 Activity Clustered Spurt 63. 5 (5. 5) 60. 6 (7. 7) 0. 1503 Clustered 17. 1 (7. 8) 23. 6 (8. 7) 0. 0113 Sustained Activity 1 two-tailed t-test

Formative Phase Conclusion ● Young children appear to participate in MVPA throughout most of 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.

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

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