Reducing Health Disparities in Childhood Obesity

NCT ID: NCT04072549

Last Updated: 2024-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

651 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-26

Study Completion Date

2024-05-01

Brief Summary

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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

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Summer Programming

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.

Group Type EXPERIMENTAL

Free Summer Programming

Intervention Type 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.

Comparison/Control

The children in the control group will be children enrolled in the same schools as those randomized to receive summer programming. The comparison/control group will not receive a voucher to attend a summer camp.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Free Summer Programming

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Michael Beets

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of South Carolina

Columbia, South Carolina, United States

Site Status

Michael Beets

Columbia, South Carolina, United States

Site Status

Countries

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United States

References

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Beets MW, Burkart S, Pfledderer C, Adams E, Glenn Weaver R, Armstrong B, Brazendale K, Zhu X, Chen B, McLain A. Impact of Free Summer Day Camp on Physical Activity Behaviors and Screentime of Elementary-age Children from Low-Income Households: A Randomized Clinical Trial. Res Sq [Preprint]. 2025 May 13:rs.3.rs-6353093. doi: 10.21203/rs.3.rs-6353093/v1.

Reference Type DERIVED
PMID: 40470250 (View on PubMed)

Beets MW, Burkart S, Pfledderer C, Adams E, Weaver RG, Armstrong B, Brazendale K, Zhu X, Chen B, McLain A. Free Summer Programming and Body Mass Index Among Schoolchildren From Low-Income Households: A Randomized Clinical Trial. JAMA Pediatr. 2024 Dec 1;178(12):1252-1259. doi: 10.1001/jamapediatrics.2024.3693.

Reference Type DERIVED
PMID: 39401051 (View on PubMed)

Other Identifiers

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Pro00086238

Identifier Type: -

Identifier Source: org_study_id

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