Community Active and Healthy Families
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Obesity, Childhood
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Wait list controlMasking: Double (Investigator, Outcomes Assessor)Masking Description: Outcome assessor will not be aware of intervention allocationPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 5 years and 99 years
- Gender
- Both males and females
Description
To address childhood overweight disparities among Latino children in immigrant families a pragmatic effectiveness trial of a community-based obesity treatment program, Community Active and Healthy Families (AHF), among 5-12 year old overweight and obese Latino children in immigrant families using a ...
To address childhood overweight disparities among Latino children in immigrant families a pragmatic effectiveness trial of a community-based obesity treatment program, Community Active and Healthy Families (AHF), among 5-12 year old overweight and obese Latino children in immigrant families using a wait-list control randomized design will be conducted. The hypothesis is that children randomized to Community-AHF will demonstrate a reduction in child body mass index (primary outcome) and improved diet physical activity behaviors (secondary outcomes) at intervention completion compared with wait-list controls. The trial will evaluate whether Community-AHF is effective at decreasing BMI among overweight or obese Latino children. Overweight (BMIz score>85th%ile) and obese (BMIz score>95th%ile) 5-12 year-old patients referred by their primary care pediatrician will be enrolled in the trial. The primary outcome will be change in BMI from baseline to 10 months.Other measures include diet and physical activity for children and parents, hypothesized mediators of the intervention, and important sociodemographic characteristics. The trial will aim to have ? 120 participants in each arm at the conclusion, 10 months after baseline. To accomplish this, 300 participants will be randomized for optimal statistical power. The sample size for was calculated to detect 0.7 kg/m2 lower mean BMI in the Community-AHF versus the waitlist control at 10 months after randomization.
Tracking Information
- NCT #
- NCT04414553
- Collaborators
- Johns Hopkins University
- Investigators
- Principal Investigator: Lisa R DeCamp, MD, MSPH University of Colorado, Denver