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临床试验/NCT04085965
NCT04085965已完成不适用

Testing the Feasibility and Preliminary Effect of Summer Day Camp on Excess Summer Weight Gain in Children From Low-income Communities

The Miriam Hospital2 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2017年5月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
94
试验地点
2
主要终点
Completion of study measures

研究概览

简要总结

This pilot randomized controlled trial was designed to assess the feasibility and preliminary efficacy of randomizing children, ages 6-12 years from two low-income communities in Rhode Island, to attend a summer day camp (CAMP) or to experience summer as usual (SAU). Children randomized to CAMP attended a Boys and Girls Club summer day camp for 8-weeks in summer 2017 or 2018. As part of the consent process, children randomized to SAU agreed to experience an unstructured summer (i.e. not enroll in more than one week of summer camp, summer school or other structured summer programming). Primary feasibility outcomes included retention, engagement and completion of midsummer measures. Secondary outcomes, change in BMIz (a proxy for excess summer weight gain), physical activity engagement, sedentary behavior, and diet (energy intake and diet quality), were collected by blinded research staff at the end of the school year, midsummer and the end of the summer.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Qualify for free or reduced-price meals at school
  • Speak English (for purposes of camp participation)
  • Agree, along with their parent(s), to randomization.

排除标准

  • A medical condition that interferes with participation in physical activity
  • Enrollment in summer programming (camp, summer school, etc) for more than one week

研究组 & 干预措施

CAMP

Experimental

Children randomized to CAMP were enrolled in the Boys and Girls Club Camp in one of two low-income Rhode Island communities in summer 2017 or 2018 for 7-weeks in 2017 and 8-weeks in 2018 due to a delayed end to the 2017 school year (i.e. snow days). Camp was offered daily from 8:30 to 4:30.

干预措施: Boys and Girls Club summer day camp (Behavioral)

Summer As Usual

No Intervention

Children randomized to the SAU group were asked to experience an unstructured summer as otherwise planned by their parent / guardian. They agreed to not attend structured summer programming (i.e. camp, summer school, or day care) for more than one week over the summer so as to provide an inactive control group for comparison to those in CAMP.

结局指标

主要结局

Completion of study measures

时间窗: Baseline (May / June); Midsummer (mid-July)

Number of participants who completed three 24-hour diet recalls and/or 7-days of actigraphy at baseline and mid-summer assessment visits

Retention

时间窗: Baseline to end of summer; 8 weeks

Number of participants who completed both baseline and end of summer assessments

Camp Attendance

时间窗: 8 weeks

Number of days children attended the Boys and Girls Club Camp

Participation in Summer Activities

时间窗: 8 weeks

Number of days children attended camp, summer school, or day care over the summer

次要结局

  • Excess summer weight gain(Baseline to end of summer; 8 weeks)
  • Diet Quality(4-6 weeks (from baseline (end of May / beginning of June) to mid-summer (mid-July)))
  • Sedentary Behavior(4-6 weeks (from baseline (end of May / beginning of June) to mid-summer (mid-July)))
  • Physical Activity(4-6 weeks (from baseline (end of May / beginning of June) to mid-summer (mid-July)))
  • Energy Intake(4-6 weeks (from baseline (end of May / beginning of June) to mid-summer (mid-July)))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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