- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03141151
Competency-based Approaches to Community Health (COACH)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The complex multi-level determinants of childhood obesity necessitate a personalized approach. One of the main challenges to effective behavior change interventions is the complexity of the systems in which these behaviors are situated. Namely, health behaviors are the result of the confluence of macro-level influences (e.g., the built environment, family, etc.) and micro-level influences (e.g., stress). Furthermore, it is imperative that attempts to support healthy childhood growth consider the foundational contribution of a person's culture to their health behaviors, especially as children from traditionally underserved minorities are often hardest hit by obesity.
This program will test a 15 week behavioral intervention followed by 3 months of coaching calls that uses principles from the learning sciences and health behavior change to help shape healthy behaviors in the context of family. The follow-up of the study will last 1 year. The content of the intervention will focus on health behavior change, including teaching goal-setting and self monitoring skills, as well as parenting strategies.
The primary outcome of interest will be early childhood BMI trajectory over 1 year. Additional measures will include survey data to measure parent and child health behaviors (e.g., diet, physical activity, sleep, media use) that are associated with obesity.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tennessee
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Nashville, Tennessee, United States, 37212
- Vanderbilt University Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Three-to-five year old child
- Spanish or English-speaking
- Child's BMI ≥ 50%
- Parental commitment to participate in a year long study
- Consistent phone access
- Parent age ≥ 18 years
- Child completion of baseline data collection on height, weight, and waist circumference and all willing survey items completed by the parent
- Parents and children must be healthy (parents with controlled medical conditions will also be eligible).
- Dyad must be considered underserved which will be indicated by the parents self-reporting if they or someone in their household participate in one of these programs or services: TennCare, CoverKids, WIC, Food Stamps (SNAP), Free and Reduced Price School Lunch and Breakfast, Families First (TANF), and/or subsidized housing
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: COACH: Healthy Bodies
This will be a staged intensity behavioral intervention.
The intensive phase will last 15 weeks and consist of weekly, 90 minute, skills-building sessions.
The content will focus on diet, physical activity, sleep, media use, and parenting.
Behavior change techniques will include goal-setting, self-monitoring, and problem solving.
Following the intensive phase, participants will enter a maintenance phase, consisting of monthly phone calls from a health coach for 3 months.
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Staged intensity behavioral intervention focusing on healthy lifestyles in the context of family.
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Active Comparator: COACH: Strong minds
This will be a school-readiness intervention for the 3-5 year old children involved, which will meet twice a month for 3 months.
Group sessions will focus on building social support around literacy skills for parents and children, as well as school advocacy.
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School Readiness Intervention focusing on literacy and parent skills
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Child Body Mass Index
Time Frame: Baseline, 4 months, 7 months, 1 year
|
child BMI trajectory across 12 months; BMI differences over time are estimates from the longitudinal mixed-effects regression model
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Baseline, 4 months, 7 months, 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child Diet: Soda
Time Frame: 4 months
|
Parent-reported survey data; Child diet: Soda was measured by a single survey item used in the Feeding Infants and Toddlers Study with higher values representing higher frequency of consumption per day.
(citation: Ziegler P, Briefel R, Clusen N, et al.
Feeding Infants and Toddlers Study (FITS): Development of the FITS survey in comparison to other dietary survey methods.
J Am Diet Assoc 2006;106:S12-S27.)
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4 months
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Child Physical Activity
Time Frame: 4 months
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Parent-reported survey data
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4 months
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Parent BMI
Time Frame: 4 months
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4 months
|
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Parent Diet Practices
Time Frame: 4 months
|
Self-reported survey data; Parent diet practices were measured by using a summed score of a 4-item questionnaire of eating behaviors, including overeating, unplanned eating, making poor food choices, and emotional eating.
Higher scores represent more unhealthy parent dieting practices.
Items ranged on a scale from 0-5 and were summed to create the scale which ranged from 0-20.
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4 months
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Parenting Practices: Engagement
Time Frame: 4 months
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Self-reported survey data; Parenting practices around child physical activity were measured by the Preschooler Physical Activity Parenting Practices (PPAPP) scale which has an engagement subscale.
Parenting practices: Engagement was a 15 item subscale of the PPAPP survey with higher scores representing higher parent engagement practices.
Items ranged on a scale from 1-5 and were summed to create the subscale which ranged from 15-75.
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4 months
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Collaborators and Investigators
Investigators
- Principal Investigator: William Heerman, MD MPH, Vanderbilt University Medical Center
Publications and helpful links
General Publications
- Heerman WJ, Teeters L, Sommer EC, Burgess LE, Escarfuller J, Van Wyk C, Barkin SL, Duhon AA, Cole J, Samuels LR, Singer-Gabella M. Competency-Based Approaches to Community Health: A Randomized Controlled Trial to Reduce Childhood Obesity among Latino Preschool-Aged Children. Child Obes. 2019 Dec;15(8):519-531. doi: 10.1089/chi.2019.0064. Epub 2019 Aug 5.
- Adams LE, Sommer EC, Truesdale KP, Barkin SL, Heerman WJ. Validation of a new scoring approach of a child dietary questionnaire for use in early childhood among low-income, Latino populations. BMC Nutr. 2022 Oct 31;8(1):125. doi: 10.1186/s40795-022-00618-4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 170420
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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