University of Central Florida
Orlando, Florida, 32816, United States
Location status: Recruiting
NCT Number: NCT07464015
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.
Interested in participating?
Request Info5 year–11 year
All sexes
Interventional
Not applicable
Orlando, Florida, 32816, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Attendance at a Boys and Girls Club of Central Florida summer day camp
Time frame: Baseline (pre-summer) and Follow-Up (3 months post-baseline)
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.
Time frame: Baseline (pre-summer) and Follow-Up (3 months post-baseline)
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.
Time frame: 14-day observation period
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.
Time frame: 14-day observation period
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.
Time frame: 14-day observation period
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.
Contact information is provided by the study sponsor or research team.
University of Central Florida
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07738029
Body Weight, Nutrition Disorders
Tampere, Pirkanmaa, Finland
View Trial DetailsNCT07728383
Body Weight, Nutrition Disorders
Minneapolis, Minnesota, United States
View Trial DetailsNCT07317310
Behavior, Body Weight
Taipei, Taiwan
View Trial DetailsNCT07724522
Body Weight, Cardiovascular Diseases
Washington D.C., District of Columbia, United States
View Trial Details