- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04544137
Summer Food Service Program
September 3, 2020 updated by: The Miriam Hospital
Evaluation and Enhancement of the Summer Food Service Program in Youth From an Urban, Low-resource Community
This pilot trial is designed to test the acceptability and preliminary efficacy of offering the BOKS program, an evidence-based physical activity curriculum that engages school-age children in moderate to vigorous physical activity for one hour daily, alongside the USDA's Summer Food Service Program (SFSP) during the summer.
Eighty children, ages 6-12 years and from low-income households, will be randomized to participate in the BOKS + SFSP program or to the SFSP alone.
We anticipate that the BOKS program will not only provide increased physical activity for the participants, but that it will help to promote participation in the SFSP given that it will be offered in the same location directly before the SFSP lunches are served.
Study Overview
Detailed Description
Youth from low-resource communities are disproportionately affected by childhood obesity, independent of race and ethnicity.
A time of particular vulnerability for excess weight gain in low-income youth is the summer.
Findings from three separate low-income populations show that BMI z-scores (BMIz) decrease during the school year and increase during the summer in this population.
To address this and aid in national obesity prevention efforts, the Institute of Medicine and the White House Task Force on Childhood Obesity recommend increased access to the Summer Food Service Program (SFSP), a federally-funded program that provides a free, healthy lunch meal to youth during the summer.
However, participation in the SFSP is low.
Based on qualitative work with families from low-income communities, this pilot trial is designed to test the acceptability and and preliminary efficacy of the BOKS program, an evidence-based physical activity curriculum that engages school-age children in moderate to vigorous physical activity for one hour daily, when offered alongside the USDA's Summer Food Service Program during the summer.
Specifically, 80 children, ages 6-12 years and from low-income households, will be randomized to participate in the BOKS + SFSP program or to the SFSP alone.
To test acceptability of the combined program versus the SFSP alone, we will compare SFSP participation (attendance) across groups.
Additionally, we will examine physical fitness levels in both groups to determine if participation in the BOKS program prevents the loss of fitness gains achieved during the school year.
Study Type
Interventional
Enrollment (Actual)
43
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
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Weight Control and Diabetes Research Center
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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:
- Reside in the low-income, Rhode Island community where BOKS program is offered
- Quality for free meals as part of the NSLP, which is equivalent to a family of four having an annual income less than $43,568 in the state of Rhode Island.
- Ages 6-12 years
- Ability of the child to speak, read and write English (for purposes of the focus groups and intervention)
- Agreement to randomization
Exclusion Criteria:
- Inability to participate in routine physical activity
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: BOKS + SFSP
Children randomized to the BOKS + SFSP will be invited to attend the one-hour BOKS program four days per week for eight weeks during the summer.
The BOKS program will be run by Lifespan employed staff in the hour before the SFSP lunch service at two community locations.
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BOKS is an evidence-based physical activity program developed by Reebok to get kids active and establish a lifelong commitment to health and fitness.
It was originally developed and tested as a 12-week program offered before or after school.
In the present study, BOKS will be offered four days per week for eight weeks over the summer at a public park in one low-income community.
The program will run one-hour prior to lunch service by the USDA's Summer Food Service Program.
The BOKS curriculum includes lesson plans for 40-45 minute classes that follow the same daily format and focus on a functional fitness skill of the week (squat, plank, push up, etc) and engage participants in team-oriented games.
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No Intervention: SFSP
Children randomized to the SFSP alone group will be asked to participate in the SFSP as they would have otherwise.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability of the BOKS + SFSP Programs
Time Frame: 8 weeks
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Attendance in the SFSP
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Respiratory Fitness
Time Frame: 8 weeks
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Pacer Test
|
8 weeks
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Excess Summer Weight gain
Time Frame: 8 weeks
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Change in BMIz
|
8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 14, 2019
Primary Completion (Actual)
August 27, 2019
Study Completion (Actual)
September 30, 2019
Study Registration Dates
First Submitted
September 3, 2020
First Submitted That Met QC Criteria
September 3, 2020
First Posted (Actual)
September 10, 2020
Study Record Updates
Last Update Posted (Actual)
September 10, 2020
Last Update Submitted That Met QC Criteria
September 3, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 207716
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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