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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.

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Sites and contacts
Official record

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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
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.

Keith Brazendale, PhD contact

4078230786

keith.brazendale@ucf.edu

United States1 site, 1 recruiting
  • University of Central Florida

    Orlando, Florida, 32816

    Keith Brazendale, PhD, 4078230786, keith.brazendale@ucf.edu

    Recruiting

Other trials in United States

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.

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 groups in NCT07464015
Study groupRoleWhat they receive
Summer Day Camp VoucherExperimentalChildren (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
ControlNo interventionChildren (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.

  1. 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)

  2. 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)
  1. 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

  2. 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

  3. 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.

  1. First posted11 Mar 2026
  2. Study start4 May 2026
  3. Primary completionAug 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

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)
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

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