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Clinical Trials/NCT04085965
NCT04085965
Completed
Not Applicable

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

The Miriam Hospital1 site in 1 country94 target enrollmentStarted: May 17, 2017Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
94
Locations
1
Primary Endpoint
Completion of study measures

Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
6 Years to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Completion of study measures

Time Frame: 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

Time Frame: Baseline to end of summer; 8 weeks

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

Camp Attendance

Time Frame: 8 weeks

Number of days children attended the Boys and Girls Club Camp

Participation in Summer Activities

Time Frame: 8 weeks

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

Secondary Outcomes

  • 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)))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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