NCT04072549

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
651

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Aug 2019

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

August 26, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

May 22, 2026

Completed
Last Updated

May 22, 2026

Status Verified

April 1, 2026

Enrollment Period

4.7 years

First QC Date

August 26, 2019

Results QC Date

September 24, 2025

Last Update Submit

April 29, 2026

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • BMI Age-Sex Specific Z-Score

    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

    Baseline and 3 months

Secondary Outcomes (4)

  • Moderate-to-Vigorous Physical Activity

    2 months

  • Sleep

    2 months

  • Diet

    2 months

  • Screen Time

    2 months

Study Arms (2)

Summer Programming

EXPERIMENTAL

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.

Behavioral: Free Summer Programming

Comparison/Control

NO INTERVENTION

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.

Interventions

Free Summer ProgrammingBEHAVIORAL

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.

Summer Programming

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of South Carolina

Columbia, South Carolina, 29201, United States

Location

Michael Beets

Columbia, South Carolina, 29208, United States

Location

Related Publications (3)

  • Beets MW, Burkart S, Pfledderer CD, Adams E, Weaver RG, 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. Int J Behav Nutr Phys Act. 2025 Dec 29;22(1):159. doi: 10.1186/s12966-025-01852-2.

    PMID: 41466370DERIVED

  • 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.

    PMID: 40470250DERIVED

  • 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.

    PMID: 39401051DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

Limitations include having the study in a single, mid-sized metropolitan city in the southeastern US. These findings may not generalize to other geographical regions.

Results Point of Contact

Title
Michael Beets
Organization
University of South Carolina
beets@mailbox.sc.edu
8037773003

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 26, 2019

First Posted

August 28, 2019

Study Start

August 26, 2019

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

May 22, 2026

Results First Posted

May 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)