N/A
Completed N=267
A Trial of Two Family-based Childhood Obesity Treatment Programs
Obesity, Childhood
Source: ClinicalTrials.gov NCT03245775 ↗
Enrolled (actual)
267
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcomePrimary: Change From Baseline in Child Body Mass Index (BMI) Z-score at 6 Months — 0.03; 0.00 z-scores
Summary
The primary aim is to determine the relative effectiveness in child BMI z-scores at 3, 6, and 12-months post baseline of iChoose+ versus Family Connections. Secondary aims are to determine (1) ongoing reach, fidelity, and implementation costs, (2) community capacity for implementation and sustainability, (3) relative impact on family eating/physical activity and parental weight, and (4) relative adherence and potential dose response relationships.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Child Body Mass Index (BMI) Z-score at 6 Months |
0.03; 0.00 | — |
| SECONDARY Change From Baseline of Parent Body Mass Index (BMI) at 6 Months |
-1.04; 0.04 | — |
| SECONDARY Change From Baseline in the Pediatric Quality of Life Inventory for Children Score at 6 Months |
-0.7; 5.0 | — |
| SECONDARY Change From Baseline in the Healthy Days Core Module for Parents at 6 Months |
3.1; -3.8 | — |
Eligibility Criteria
Inclusion Criteria
- Parent/child dyads will be eligible for participation if they reside in the Dan River Region
- English speaking
- child with a BMI percentile ranking of 85 or higher
- Cohort 3 age eligibility changed from 8-12 to 5-15
Exclusion Criteria
- children with a major cognitive impairment and parents or children with a medical contraindication for moderate physical activity.
Data sourced from ClinicalTrials.gov (NCT03245775). 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. Informational only — not medical advice.