Actively Recruiting

Phase Not Applicable
Age: 5Years - 11Years
All Genders
NCT07464015

Feasibility and Acceptability of a Pediatric Referral to Summer Day Camps to Treat Obesity in Children From Low-Income Households

Led by University of Central Florida · Updated on 2026-05-01

80

Participants Needed

1

Research Sites

69 weeks

Total Duration

On this page

Sponsors

U

University of Central Florida

Lead Sponsor

N

National Institute of Nursing Research (NINR)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Feasibility and Acceptability of a Pediatric Referral to Summer Day Camps to Treat Obesity in Children From Low-Income Households

Who Can Participate

Age: 5Years - 11Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Child is overweight or obese
  • Child attends a pediatric clinic
  • Child has Medicaid insurance
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Central Florida

Orlando, Florida, United States, 32816

Actively Recruiting

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Research Team

K

Keith Brazendale, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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