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临床试验/NCT07464015
NCT07464015招募中不适用

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

University of Central Florida1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年5月4日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
Height in centimeters

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
5 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Overweight or Obese
  • Attends pediatric clinic
  • Medicaid Insured

排除标准

  • 未提供

研究组 & 干预措施

Control

No Intervention

Children (n=40) randomized to the control group arm will continue summer as usual

Summer Day Camp Voucher

Experimental

Children (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

干预措施: Summer Day Camp (Behavioral)

结局指标

主要结局

Height in centimeters

时间窗: 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.

Weight in kilograms

时间窗: 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.

次要结局

  • Obesogenic Behaviors - Physical Activity(14-day observation period)
  • Obesogenic Behaviors - Sleep(14-day observation period)
  • Obesogenic Behaviors - Diet(14-day observation period)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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