Reducing Health Disparities in Childhood Obesity

Not Applicable

Completed

• Conditions: Obesity

• Registration Number: NCT04072549
• Lead Sponsor: University of South Carolina

Brief Summary

In this study, we will address cost barriers to participating in summer programs and hypothesize this will lead to marked improvements in children's obesogenic behaviors and a reduction in excessive, unhealthy weight gain over summer.

Detailed Description

For this study, we will rigorously test the impact of providing access to existing community-operated summer programs on weight status (i.e., BMI z-score) and obesogenic behaviors of 1st-3rd grade children from low-income households. Using a pragmatic, Type II hybrid effectiveness-implementation randomized design, we will compare changes in weight status and obesogenic behaviors of children from low-income households randomized to one of two conditions: free summer programming or comparison/control.

Study Timeline

• Study Start: 2019-08-26
• Study First Submitted: 2019-08-26
• Study First Submitted QC: 2019-08-27
• Study First Posted: 2019-08-28
• Status Verified: 2024-05
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-01
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 651

Inclusion Criteria

1st through 3rd grade students in the participating schools.

Exclusion Criteria

The only exclusion criteria will be the diagnosis of an intellectual disability, such as:

Autism Spectrum Disorder Down Syndrome Fragile X Fetal Alcohol and/or a physical disability, such as wheelchair use

This decision was made because of the added resources required to evaluate these children, as well as the inability to sample enough of these children to adequately draw conclusions.

No other exclusion criteria will be used.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
BMI	Baseline and 3 months	Change in Body Mass Index - height and weight

Secondary Outcome Measures

Name	Time	Method
Diet	Baseline and 2 months	Parent report of child dietary intake (healthy eating index)
Sleep	Baseline and 2 months	Accelerometer-derived sleep (minutes per day)
Physical Activity	Baseline and 2 months	Accelerometer-derived physical activity (minutes per day)
Screen Time	Baseline and 2 months	Parent report of screen time usage (minutes per day)

Trial Locations

Locations (2)

University of South Carolina; 🇺🇸 Columbia, South Carolina, United States

Michael Beets; 🇺🇸 Columbia, South Carolina, United States