80 Participants NeededMy employer runs this trial

Summer Day Camps for Childhood Obesity

KB
Overseen ByKeith Brazendale, PhD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of Central Florida
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

Overweight or Obese
Attends pediatric clinic
I have Medicaid insurance.

Exclusion Criteria

I have no additional requirements for this criterion.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Children receive a voucher referral to attend a summer day camp for 8 weeks free-of-charge

8 weeks
Continuous attendance at summer day camp

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
1 visit (in-person) for follow-up measurements

What Are the Treatments Tested in This Trial?

Interventions

  • Summer Day Camp

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Summer Day Camp VoucherExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Central Florida

Lead Sponsor

Trials
101
Recruited
1,191,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials
623
Recruited
10,400,000+