[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07464015":3,"trial-entities:NCT07464015":86,"trial-summary:NCT07464015":91},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":34,"secondary_outcomes":42,"sex":53,"minimum_age":54,"maximum_age":55,"healthy_volunteers":14,"eligibility_criteria":56,"std_ages":64,"locations":66,"central_contacts":81,"overall_officials":83,"references":84,"see_also_links":85},"NCT07464015","STUDY00008221","Feasibility and Acceptability of a Pediatric Referral to Summer Day Camps to Treat Obesity in Children From Low-Income Households","RECRUITING","2027-09","2026-02","2026-05-01","2026-05","University of Central Florida","OTHER",false,"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\u002Fprograms, 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\u002Fobese. 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\u002Fbeverages 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\u002Fguardians (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\u002Ffamilies 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\u002Fbarriers 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\u002Ffamilies 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.",null,[18],"Obesity & Overweight",[],"INTERVENTIONAL","TREATMENT",[23],"NA",{"count":25,"type":26},80,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"BEHAVIORAL","Summer Day Camp","Attendance at a Boys and Girls Club of Central Florida summer day camp",[33],"Summer Day Camp Voucher",[35,39],{"measure":36,"description":37,"timeFrame":38},"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\u002Fm\\^2.","Baseline (pre-summer) and Follow-Up (3 months post-baseline)",{"measure":40,"description":41,"timeFrame":38},"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\u002Fm\\^2.",[43,47,50],{"measure":44,"description":45,"timeFrame":46},"Obesogenic Behaviors - Physical Activity","Summer differences in physical activity between children in treatment and control group.\n\nEach 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.","14-day observation period",{"measure":48,"description":49,"timeFrame":46},"Obesogenic Behaviors - Sleep","Summer differences in sleep between children in treatment and control group.\n\nEach 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.",{"measure":51,"description":52,"timeFrame":46},"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.","ALL","5 Years","11 Years",{"inclusion":57,"exclusion":61,"raw_text":63},[58,59,60],"Overweight or Obese","Attends pediatric clinic","Medicaid Insured",[62],"None","Inclusion Criteria:\n\n* Overweight or Obese\n* Attends pediatric clinic\n* Medicaid Insured\n\nExclusion Criteria:\n\n* None",[65],"CHILD",[67],{"facility":12,"status":7,"city":68,"state":69,"zip":70,"country":71,"contacts":72,"geoPoint":78},"Orlando","Florida","32816","United States",[73],{"name":74,"role":75,"phone":76,"email":77},"Keith Brazendale, PhD","CONTACT","4078230786","keith.brazendale@ucf.edu",{"lat":79,"lon":80},28.53834,-81.37924,[82],{"name":74,"role":75,"phone":76,"email":77},[],[],[],{"nct_id":4,"conditions":87,"biomarkers":90},[88,89],"Obesity","Overweight",[],{"nct_id":4,"found":92,"summary":93,"prompt_version":103},true,{"design":94,"status":95,"heading":96,"summary":97,"follow_up":98,"word_count":99,"commitments":100,"compensation":101,"drugs_mentioned":102},"This is an interventional study planning to enroll 80 participants. It is not specified if it is randomized or blinded.","completed","Summer Day Camps for Childhood Obesity in Low-Income Households","This study is looking at whether referring children from low-income families to summer day camps can help treat obesity. It's for children aged 5 to 11 who are overweight or obese, attend a pediatric clinic, and have Medicaid insurance. The study will measure changes in your child's height and weight before the summer camp and then again three months after the camp ends. The goal is to see if attending a Boys and Girls Club of Central Florida summer day camp is a practical and acceptable way to help children manage their weight. The current status of this study is unclear.","Participants will be followed for three months after the summer camp ends.",101,"Your child would attend a Boys and Girls Club of Central Florida summer day camp. Their height and weight would be measured before the summer and three months after.","Not stated in the trial record.",[30],"v2"]