N/A
N=117
Competency-based Approaches to Community Health
Obesity, Childhood
Bottom Line
View on ClinicalTrials.gov: NCT03141151 ↗Enrolled (actual)
117
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Change in Child Body Mass Index — 18.1; 18.1; 18.1; 18.2 kg/m^2
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- COACH: Healthy Bodies (Behavioral); COACH: Strong Minds (Behavioral)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Child Body Mass Index |
18.1; 18.1; 18.1; 18.2; 18.0; 18.4 | — |
| SECONDARY Child Diet: Soda |
0.17; 0.19 | — |
| SECONDARY Child Physical Activity |
2.00; 1.62 | — |
| SECONDARY Parent BMI |
30.44; 31.57 | — |
| SECONDARY Parent Diet Practices |
5.04; 5.22 | — |
| SECONDARY Parenting Practices: Engagement |
53.79; 49.52 | — |
Summary
This study is a family-centered, community-based intervention to prevent and treat childhood obesity among 3-5 year old children from undeserved communities. Half of participants will receive a healthy lifestyle intervention and half of participants will receive a school-readiness intervention.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03141151). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.