Health Status DisparitiesPhase 2DOSENCT06158594
Determining the Optimal Amount of Structured Environments for Healthy Kids
A Phase 2 study testing Summer day camp in people with Health Status Disparities and Pediatric Obesity, run by University of South Carolina at 1 site in United States.
Trial summary
Studies show that virtually all increases in children's (5-12yrs) BMI occur during the summer, no matter children's' weight status (i.e., normal weight, overweight, or obese) at summer entry. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Status Disparities, Pediatric Obesity, Ethnic Groups
- What is being tested?
- Summer day camp
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 31 Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- k-4th grader in a partner school
- eligible for free and reduced price lunch (a widely recognized indicator of
- socioeconomic level and poverty status)
- parent that indicates "yes' on an informed consent document for participation in the study
Who cannot join
- Diagnosis of an intellectual disability, such as Down Syndrome, Fragile X, Fetal Alcohol
- a physical disability, such as wheelchair use, that prevents the ability to ambulate without assistance.
- Families who plan to enroll their children in a summer camp or relocate (i.e., move) during the 14-month period that they participate
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina
Columbia, South Carolina, 29205
About this study
Official title: Identifying the Ideal Dose of Structured Summer Programming for Mitigating Accelerated Summer BMI Gain
Studies show that virtually all increases in children's (5-12yrs) BMI occur during the summer, no matter children's' weight status (i.e., normal weight, overweight, or obese) at summer entry. Recent preliminary studies show that children engage in healthier behaviors on days that they attend summer day camps, and that BMI gain does not accelerate for these children. The proposed randomized dose-response study will identify the dose-response relationship between amount of summer programming and summer BMI gain.
Read the detailed description
Summer is a period of accelerated BMI gain for children (5-12yrs). Studies show that virtually all increases in BMI occur during the summer, no matter children's' weight status (i.e., normal weight, overweight, or obese) at summer entry. Our research team recently developed the Structured Days Hypothesis (SDH), which may explain accelerated summer BMI gain. The SDH posits that structure, defined as pre-planned, segmented, and adult-supervised compulsory environments, protect children against obesogenic behaviors and prevent excessive BMI gain. The SDH draws upon the 'filled-time perspective', which posits that time filled with favorable activities cannot be filled with unfavorable activities. In the context of the SDH, this means that children engage in more obesogenic behaviors that lead to increased weight gain during times that are less-structured (e.g., summer days) compared to times that are more structured (e.g., school days). Based on the SDH, pre-existing community-operated summer day camps (e.g., B\&G Club, YMCA), may exert a positive influence on summer BMI gain by limiting children's engagement in obesogenic behaviors. Recent preliminary studies show that children engage in healthier behaviors on days that they attend summer day camps, and that BMI gain does not accelerate for these children. A major weakness in the rigor of these preliminary studies is that they cannot identify the dose-response relationship between structured summer programming and summer BMI gain. Dose-response studies can definitively identify the smallest dose at which a useful effect is observed while simultaneously revealing the maximum dose beyond which there is no further beneficial effect. In the same way determining the effective dose of structure to mitigate negative health outcomes is necessary to inform feasible, scalable interventions and health policy. The proposed randomized dose-response study will identify the dose-response relationship between amount of summer programming and summer BMI gain. The impact of 4 weeks (n=90, 20 days), 6 weeks (n=90, 30 days), and 8 weeks (n=90, 40 days) of summer programming compared to no program (n=90) will be evaluated. Comprehensive implementation monitoring to evaluate implementation will also be conducted. This will identify factors associated with children's summer BMI gain and obesogenic behaviors. The aims of the study are to: Aim 1. Evaluate structured summer programming's impact on children's BMI gain and obesogenic behaviors. Aim 2. Evaluate implementation and contextual factors and their relationship with children's summer BMI gain and obesogenic behaviors. Aim 3. Determine the cost effectiveness of 4, 6, 8 weeks of summer programming for mitigating accelerated summer BMI gain. This work is significant as it addresses a critical public health goal - reducing obesity - through programing during a timeframe - summer vacation - when substantial, long-lasting negative effects occur. This application is innovative because of the focus on identifying the dose-response relationship between structured summer programming and summer BMI gain. This innovation addresses a weakness in the rigor of previous studies and is critical for identifying the ideal dose of summer programming for mitigating accelerated summer BMI gain.
- Being tested
- Summer day camp
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Summer day campBehavioural
The summer day camp programs are existing camps which take place at schools from which children will be recruited. The 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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Children in this group will not receive a voucher to attend a pre-existing summer program |
| 4-week voucher | Experimental | Children in this group will receive a voucher to attend 4-weeks of a pre-existing summer program Receives: Behavioral: Summer day camp |
| 6-week voucher | Experimental | Children in this group will receive a voucher to attend 6-weeks of a pre-existing summer program Receives: Behavioral: Summer day camp |
| 8-week voucher | Experimental | Children in this group will receive a voucher to attend 8-weeks of a pre-existing summer program Receives: Behavioral: Summer day camp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index
BMI translated into BMI z-scores based on Centers for Disease Control age-sex-specific zBMI growth charts
Measured: End of school year (0 months, start of summer), beginning of school year (3 months, end of summer) and end of following school year (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start1 Mar 2024
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health Status DisparitiesStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, R. Glenn Weaver, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06158594
- Sponsor's protocol ID
- Pro00125467
- Acronym
- DOSE
- Status last verified
- Sep 2026
- First submitted
- 27 Nov 2023
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kiely KP, Beets MW, Adams EL, Pate RR, Brian C, Bridget A, Sarah B, Cepni AB, Holmes AJ, White JW, Olivia F, Meghan S, Hannah P, Randolph GAT, Xuanxuan Z, Weaver RG. Protocol for a randomized controlled dose response trial to combat accelerated summer BMI gain in children: The Determining the Optimal amount of Structured Environments (DOSE) study. Contemp Clin Trials. 2025 Apr;151:107840. doi: 10.1016/j.cct.2025.107840. Epub 2025 Feb 10.
PubMed 39938613
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying the Ideal Dose of Structured Summer Programming for Mitigating Accelerated Summer BMI Gain
- ClinicalTrials.gov ID
- NCT06158594
- Acronym / sponsor ID
- DOSE / Pro00125467
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Studies show that virtually all increases in children's (5-12yrs) BMI occur during the summer, no matter children's' weight status (i.e., normal weight, overweight, or obese) at summer entry. Recent preliminary studies show that children engage in healthier behaviors on days that they attend summer day camps, and that BMI gain does not accelerate for these children. The proposed randomized dose-response study will identify the dose-response relationship between amount of summer programming and summer BMI gain.
Detailed description
Summer is a period of accelerated BMI gain for children (5-12yrs). Studies show that virtually all increases in BMI occur during the summer, no matter children's' weight status (i.e., normal weight, overweight, or obese) at summer entry. Our research team recently developed the Structured Days Hypothesis (SDH), which may explain accelerated summer BMI gain. The SDH posits that structure, defined as pre-planned, segmented, and adult-supervised compulsory environments, protect children against obesogenic behaviors and prevent excessive BMI gain. The SDH draws upon the 'filled-time perspective', which posits that time filled with favorable activities cannot be filled with unfavorable activities. In the context of the SDH, this means that children engage in more obesogenic behaviors that lead to increased weight gain during times that are less-structured (e.g., summer days) compared to times that are more structured (e.g., school days). Based on the SDH, pre-existing community-operated summer day camps (e.g., B\&G Club, YMCA), may exert a positive influence on summer BMI gain by limiting children's engagement in obesogenic behaviors. Recent preliminary studies show that children engage in healthier behaviors on days that they attend summer day camps, and that BMI gain does not accelerate for these children. A major weakness in the rigor of these preliminary studies is that they cannot identify the dose-response relationship between structured summer programming and summer BMI gain. Dose-response studies can definitively identify the smallest dose at which a useful effect is observed while simultaneously revealing the maximum dose beyond which there is no further beneficial effect. In the same way determining the effective dose of structure to mitigate negative health outcomes is necessary to inform feasible, scalable interventions and health policy. The proposed randomized dose-response study will identify the dose-response relationship between amount of summer programming and summer BMI gain. The impact of 4 weeks (n=90, 20 days), 6 weeks (n=90, 30 days), and 8 weeks (n=90, 40 days) of summer programming compared to no program (n=90) will be evaluated. Comprehensive implementation monitoring to evaluate implementation will also be conducted. This will identify factors associated with children's summer BMI gain and obesogenic behaviors. The aims of the study are to: Aim 1. Evaluate structured summer programming's impact on children's BMI gain and obesogenic behaviors. Aim 2. Evaluate implementation and contextual factors and their relationship with children's summer BMI gain and obesogenic behaviors. Aim 3. Determine the cost effectiveness of 4, 6, 8 weeks of summer programming for mitigating accelerated summer BMI gain. This work is significant as it addresses a critical public health goal - reducing obesity - through programing during a timeframe - summer vacation - when substantial, long-lasting negative effects occur. This application is innovative because of the focus on identifying the dose-response relationship between structured summer programming and summer BMI gain. This innovation addresses a weakness in the rigor of previous studies and is critical for identifying the ideal dose of summer programming for mitigating accelerated summer BMI gain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Children in this group will not receive a voucher to attend a pre-existing summer program |
| 4-week voucher | Experimental | Behavioral: Summer day campChildren in this group will receive a voucher to attend 4-weeks of a pre-existing summer program |
| 6-week voucher | Experimental | Behavioral: Summer day campChildren in this group will receive a voucher to attend 6-weeks of a pre-existing summer program |
| 8-week voucher | Experimental | Behavioral: Summer day campChildren in this group will receive a voucher to attend 8-weeks of a pre-existing summer program |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- k-4th grader in a partner school
- eligible for free and reduced price lunch (a widely recognized indicator of
- socioeconomic level and poverty status)
- parent that indicates "yes' on an informed consent document for participation in the study
Key exclusion criteria (3 listed)
- Diagnosis of an intellectual disability, such as Down Syndrome, Fragile X, Fetal Alcohol
- a physical disability, such as wheelchair use, that prevents the ability to ambulate without assistance.
- Families who plan to enroll their children in a summer camp or relocate (i.e., move) during the 14-month period that they participate
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 |
|---|---|---|
| Summer day campThe summer day camp programs are existing camps which take place at schools from which children will be recruited. The 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. | Behavioural | 4-week voucher, 6-week voucher, 8-week voucher |
Primary outcome
Change in Body Mass Index
Time frame: End of school year (0 months, start of summer), beginning of school year (3 months, end of summer) and end of following school year (12 months)
BMI translated into BMI z-scores based on Centers for Disease Control age-sex-specific zBMI growth charts
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Derived from this study: PubMed 39938613Kiely KP, Beets MW, Adams EL, Pate RR, Brian C, Bridget A, Sarah B, Cepni AB, Holmes AJ, White JW, Olivia F, Meghan S, Hannah P, Randolph GAT, Xuanxuan Z, Weaver RG. Protocol for a randomized controlled dose response trial to combat accelerated summer BMI gain in children: The Determining the Optimal amount of Structured Environments (DOSE) study. Contemp Clin Trials. 2025 Apr;151:107840. doi: 10.1016/j.cct.2025.107840. Epub 2025 Feb 10.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Summer day camp in people with Health Status Disparities and Pediatric Obesity, run by University of South Carolina at 1 site 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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Change in Body Mass Index (time frame: End of school year (0 months, start of summer), beginning of school year (3 months, end of summer) and end of following school year (12 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 NCT06158594, which also lists 1 linked publication.
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 Sep 2026.