Obesity & OverweightNCT07464015
Feasibility and Acceptability of a Pediatric Referral to Summer Day Camps to Treat Obesity in Children From Low-Income Households
A study testing Summer Day Camp in people with Obesity & Overweight, run by University of Central Florida at 1 site in United States.
Trial summary
Children from low-income households have a 25-30% higher prevalence of OWOB compared to their higher-income peers. The lack of feasible and effective treatments to address obesity in children with OWOB and from low-income household's points to a real need for prioritization and urgency. The U.S. Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Obesity & Overweight
- 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
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2026to Sep 2027
- Phase
- Interventional
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 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Overweight or Obese
- Attends pediatric clinic
- Medicaid Insured
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Central Florida
Orlando, Florida, 32816
Keith Brazendale, PhD, 4078230786, keith.brazendale@ucf.edu
About this study
Children from low-income households have a 25-30% higher prevalence of OWOB compared to their higher-income peers. The lack of feasible and effective treatments to address obesity in children with OWOB and from low-income household's points to a real need for prioritization and urgency. The U.S. Preventive Services Task Force (USPSTF) notes several shortcomings with current behavioral interventions and clinical practice to treat children with OWOB. Current efforts lack the necessary intensity recommended by USPSTF (26-52 hours in a 6-month period); incorporate multi-component interventions that are not feasible to consistently deliver; do not consider barriers to services/programs, such as cost; do not explore collaborative relationships between providers and community programs, and are expressed as 'treatment', therefore, perpetuating the stigma of being overweight/obese. Our project rationale focuses on addressing these limitations during a critical time for accelerated weight-gain in children with OWOB, summer. Our pilot randomized clinical trial will provide free access for children to attend summer day camps (SDCs) as a treatment for OWOB. SDCs are settings where children show high levels of physical activity, consume foods/beverages that meet federal nutrition guidelines, and maintain a consistent sleep schedule during summer. Unfortunately, not all children have access to SDCs. Our team surveyed more than 100 parents/guardians (84% Medicaid) who have a child with OWOB and receives treatment at a pediatric clinic and ~75% reported that they would like to receive a voucher to attend a SDC and that cost was the number one reason why their child did not attend. The proposed pilot randomized clinical trial will randomize a total of 80 children with OWOB (5-11 years) who are covered by Medicaid, into two groups: (1) those who receive a pediatric voucher referral (PVR) from an pediatrician or nurse practitioner to attend an existing SDC for 8 weeks free-of- charge (n=40) or (2) those who continue to receive standard care (control; n=40). By leveraging the expertise of primary care providers and partnering with two well-positioned community partners, our team will evaluate a highly promising intervention to address cost as a barrier for children/families attending summer programming by addressing the following specific aims: 1) to examine the feasibility (intervention delivery) and acceptability (intervention uptake) of the PVR program, 2) to determine the preliminary effectiveness of the PVR program on weight outcomes, and the potential mediating influence of activity, sleep, and diet on any observed changes, and 3) to qualitatively explore the facilitators/barriers of participation in the PVR program and to identify what children and families face during the school year and summer in relation to weight management. Findings will inform the design of a R01 clinical trial. Long term goals of this proposal are to influence policies for subsidizing access to local community SDCs for children/families who meet health criteria (i.e., OWOB). Scalability of this approach is promising given the widespread presence of SDCs and pediatric health clinics in communities.
- Conditions
- Obesity & Overweight
- Being tested
- Summer Day Camp
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Summer Day CampBehavioural
Attendance at a Boys and Girls Club of Central Florida summer day camp
| Study group | Role | What they receive |
|---|---|---|
| Summer Day Camp Voucher | Experimental | Children (n=40) randomized to the experimental arm will receive a voucher 'referral' from a pediatrician or nurse practitioner to attend an existing summer day camp for 8 weeks free-of- charge Receives: Behavioral: Summer Day Camp |
| Control | No intervention | Children (n=40) randomized to the control group arm will continue summer as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height in centimeters
Height in centimeters will be captured via a stadiometer at baseline (pre-summer) and follow-up (post summer) approximately 12 weeks apart for children in the treatment and control group. Height and weight measurements will be aggregated to arrive at Body Mass Index (BMI) in kg/m^2.
Measured: Baseline (pre-summer) and Follow-Up (3 months post-baseline)
Weight in kilograms
Weight in kilograms will be captured via the Tanita C-300 scale at baseline (pre-summer) and follow-up (post summer) approximately 12 weeks apart for children in the treatment and control group. Height and weight measurements will be aggregated to arrive at Body Mass Index (BMI) in kg/m^2.
Measured: Baseline (pre-summer) and Follow-Up (3 months post-baseline)
Secondary outcomes (3)
Obesogenic Behaviors - Physical Activity
Summer differences in physical activity between children in treatment and control group.
Each study participant will wear the Actigraph Link on their non-dominant wrist for 14 days. The device is waterproof, allowing us to capture water-based activities during summer, and is extensively used in free-living child-focused studies.
Measured: 14-day observation period
Obesogenic Behaviors - Sleep
Summer differences in sleep between children in treatment and control group.
Each study participant will wear the Actigraph Link on their non-dominant wrist for 14 days. This extensively used in free-living child-focused studies for sleep.
Measured: 14-day observation period
Obesogenic Behaviors - Diet
The Beverage and Snack Questionnaire (BSQ) will capture reported consumption of Healthy Meal Index food categories, such as sugar-sweetened beverages, salty snacks, sweets, milk, fruit, and vegetables each day. Parents will complete one per day, in consultation with their child, for 14-days.
Measured: 14-day observation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start4 May 2026
- Primary completionAug 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07464015
- Sponsor's protocol ID
- STUDY00008221
- Other IDs
- 1R21NR021423-01A1
- Status last verified
- Sep 2026
- First submitted
- 19 Feb 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No