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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
94

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • The Miriam Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Miriam Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hassenfeld Child Health Innovation Institute

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 17, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 22, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 22, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 3, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings