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OpenTrials
Completed

NCT Number: NCT04072549

Reducing Health Disparities in Childhood Obesity

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michael Beets, Columbia, South Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Free Summer Programming

Behavioral

The summer day camps are not singularly focused, such as sport camps or academic only camps. Rather, the camps provide indoor and outdoor opportunities for children to be physically active each day, provide enrichment and academic programming, as well as provide breakfast, lunch, and snacks. To standardize programming, the schools operate their camps on the same daily schedules which are developed by the same district-level personnel, with identical programmatic content delivered across all schools. The schools also provide the same meals to all children enrolled. The meals adhere to the Summer Food Service Program nutrition guidelines and are reimbursed through existing federal food programs.

Primary outcomes

  1. BMI Age-Sex Specific Z-Score

    Time frame: Baseline and 3 months

    Change in Body Mass Index age=sex specific z-score. 0 represents the 50th percentile. A reduction of 0.15 is considered clinically meaningful in an already obese population

Secondary outcomes

  1. Moderate-to-Vigorous Physical Activity

    Time frame: 2 months

    Accelerometer-derived moderate-to-vigorous physical activity (minutes per day)

  2. Sleep

    Time frame: 2 months

    Accelerometer-derived sleep (minutes per day)

  3. Diet

    Time frame: 2 months

    Parent report of child dietary intake

  4. Screen Time

    Time frame: 2 months

    Parent report of screen time usage (minutes per day)

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Reducing Health Disparities in Childhood Obesity Using Financial Incentives in Low-income Households

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Aug 28, 2019
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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