- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04072549
Reducing Health Disparities in Childhood Obesity
Reducing Health Disparities in Childhood Obesity Using Financial Incentives in Low-income Households
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
South Carolina
-
Columbia, South Carolina, United States, 29201
- University of South Carolina
-
Columbia, South Carolina, United States, 29208
- Michael Beets
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
|
|
No Intervention: 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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Baseline and 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Moderate-to-Vigorous Physical Activity
Time Frame: 2 months
|
Accelerometer-derived moderate-to-vigorous physical activity (minutes per day)
|
2 months
|
|
Sleep
Time Frame: 2 months
|
Accelerometer-derived sleep (minutes per day)
|
2 months
|
|
Diet
Time Frame: 2 months
|
Parent report of child dietary intake
|
2 months
|
|
Screen Time
Time Frame: 2 months
|
Parent report of screen time usage (minutes per day)
|
2 months
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00086238
- R01DK120490 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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