ObesityNCT04072549
Reducing Health Disparities in Childhood Obesity
A study testing Free Summer Programming in people with Obesity, run by University of South Carolina at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Free Summer Programming
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 651 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Aug 2019to 1 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 1st through 3rd grade students in the participating schools.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of South Carolina
Columbia, South Carolina, 29201
Michael Beets
Columbia, South Carolina, 29208
About this study
Official title: Reducing Health Disparities in Childhood Obesity Using Financial Incentives in Low-income Households
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Free Summer Programming
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free Summer ProgrammingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and 3 months
Secondary outcomes (4)
Moderate-to-Vigorous Physical Activity
Accelerometer-derived moderate-to-vigorous physical activity (minutes per day)
Measured: 2 months
Sleep
Accelerometer-derived sleep (minutes per day)
Measured: 2 months
Diet
Parent report of child dietary intake
Measured: 2 months
Screen Time
Parent report of screen time usage (minutes per day)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start26 Aug 2019
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 651 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Beets, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04072549
- Sponsor's protocol ID
- Pro00086238
- Other IDs
- R01DK120490
- Status last verified
- Apr 2026
- First submitted
- 26 Aug 2019
- Last updated
- 22 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 41466370Beets 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.
PubMed 40470250Beets 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.
PubMed 39401051
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Health Disparities in Childhood Obesity Using Financial Incentives in Low-income Households
- ClinicalTrials.gov ID
- NCT04072549
- Acronym / sponsor ID
- Pro00086238
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 651 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Posted 22 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Summer Programming | Experimental | Behavioral: Free Summer ProgrammingThe 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 | 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. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1st through 3rd grade students in the participating schools.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Free Summer ProgrammingThe 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. | Behavioural | Summer Programming |
Primary outcome
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
4 secondary outcomes
Moderate-to-Vigorous Physical Activity
Time frame: 2 months
Sleep
Time frame: 2 months
Diet
Time frame: 2 months
Screen Time
Time frame: 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41466370Beets 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.
- Derived from this study: PubMed 40470250Beets 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.
- Derived from this study: PubMed 39401051Beets 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free Summer Programming in people with Obesity, run by University of South Carolina at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI Age-Sex Specific Z-Score (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04072549, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.