- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04085965
Testing the Feasibility and Preliminary Effect of Summer Camp
September 9, 2019 updated by: The Miriam Hospital
Testing the Feasibility and Preliminary Effect of Summer Day Camp on Excess Summer Weight Gain in Children From Low-income Communities
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
94
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02906
- The Miriam Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 12 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Retention
Time Frame: Baseline to end of summer; 8 weeks
|
Number of participants who completed both baseline and end of summer assessments
|
Baseline to end of summer; 8 weeks
|
|
Camp Attendance
Time Frame: 8 weeks
|
Number of days children attended the Boys and Girls Club Camp
|
8 weeks
|
|
Participation in Summer Activities
Time Frame: 8 weeks
|
Number of days children attended camp, summer school, or day care over the summer
|
8 weeks
|
|
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
|
Baseline (May / June); Midsummer (mid-July)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Excess summer weight gain
Time Frame: Baseline to end of summer; 8 weeks
|
Change in BMIz
|
Baseline to end of summer; 8 weeks
|
|
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
|
4-6 weeks (from baseline (end of May / beginning of June) to mid-summer (mid-July))
|
|
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
|
4-6 weeks (from baseline (end of May / beginning of June) to mid-summer (mid-July))
|
|
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
|
4-6 weeks (from baseline (end of May / beginning of June) to mid-summer (mid-July))
|
|
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
|
4-6 weeks (from baseline (end of May / beginning of June) to mid-summer (mid-July))
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 17, 2017
Primary Completion (Actual)
August 22, 2018
Study Completion (Actual)
August 22, 2018
Study Registration Dates
First Submitted
September 3, 2019
First Submitted That Met QC Criteria
September 9, 2019
First Posted (Actual)
September 11, 2019
Study Record Updates
Last Update Posted (Actual)
September 11, 2019
Last Update Submitted That Met QC Criteria
September 9, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 710-9073
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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