Recruitment

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