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Trial record 1 of 1 for:    NCT04085965
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Testing the Feasibility and Preliminary Effect of Summer Camp

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ClinicalTrials.gov Identifier: NCT04085965
Recruitment Status : Completed
First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Sponsor:
Collaborator:
Hassenfeld Child Health Innovation Institute
Information provided by (Responsible Party):
The Miriam Hospital

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.

Condition or disease Intervention/treatment Phase
Childhood Obesity Prevention Behavioral: Boys and Girls Club summer day camp Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Testing the Feasibility and Preliminary Effect of Summer Day Camp on Excess Summer Weight Gain in Children From Low-income Communities
Actual Study Start Date : May 17, 2017
Actual Primary Completion Date : August 22, 2018
Actual Study Completion Date : August 22, 2018

Arm Intervention/treatment
Experimental: CAMP
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.
Behavioral: Boys and Girls Club summer day camp
Daily camp activities included sports, games, obstacle courses, swimming and boating, summer learning and arts and crafts. Lunch was served daily via the USDA's Summer Food Service Program.

No Intervention: Summer As Usual
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.



Primary Outcome Measures :
  1. Retention [ Time Frame: Baseline to end of summer; 8 weeks ]
    Number of participants who completed both baseline and end of summer assessments

  2. Camp Attendance [ Time Frame: 8 weeks ]
    Number of days children attended the Boys and Girls Club Camp

  3. Participation in Summer Activities [ Time Frame: 8 weeks ]
    Number of days children attended camp, summer school, or day care over the summer

  4. 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


Secondary Outcome Measures :
  1. Excess summer weight gain [ Time Frame: Baseline to end of summer; 8 weeks ]
    Change in BMIz

  2. Physical Activity [ Time Frame: 4-6 weeks (from baseline (end of May / beginning of June) to mid-summer (mid-July)) ]
    Change in minutes of moderate to vigorous physical activity (MVPA) as measured by ActiGraph accelerometer

  3. Sedentary Behavior [ Time Frame: 4-6 weeks (from baseline (end of May / beginning of June) to mid-summer (mid-July)) ]
    Change in percent time spent sedentary as measured by ActiGraph accelerometer

  4. Energy Intake [ Time Frame: 4-6 weeks (from baseline (end of May / beginning of June) to mid-summer (mid-July)) ]
    Change in total energy intake as measured from 3 non-consecutive 24-hour diet recalls

  5. Diet Quality [ Time Frame: 4-6 weeks (from baseline (end of May / beginning of June) to mid-summer (mid-July)) ]
    Change in Diet Quality as measured by the HEI-2015 from three non-consecutive 24-hour diet recalls



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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04085965


Locations
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United States, Rhode Island
The Miriam Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
The Miriam Hospital
Hassenfeld Child Health Innovation Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The Miriam Hospital
ClinicalTrials.gov Identifier: NCT04085965    
Other Study ID Numbers: 710-9073
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Miriam Hospital:
Summer Camp
Child overweight / obesity
Diet
Physical Activity
Additional relevant MeSH terms:
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Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight