- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03805295
Implementation and Evaluation of a Before School Physical Activity Program in Revere, MA
December 19, 2025 updated by: Elsie Taveras, MD, Massachusetts General Hospital
This study evaluates the implementation of the BOKS program in three schools (K-8) in Revere, MA, and its effect on participating students with regard to BMI, cognitive, and quality of life outcomes.
BOKS (Build Our Kids' Success) is a before-school physical activity program that has been implemented in over 2,000 elementary and middle schools.
Two sessions will be held (Spring 2018 and Winter 2018.
This is a cohort study evaluating the impact of program participation on child BMI, quality of life, and executive function.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
188
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
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General 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
Ages Eligible for Study
1 year to 10 years (Child)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Enrolled in the BOKS program
- Participating school
- Age 5-14
Exclusion Criteria:
- No valid consent
- Not enrolled in BOKS
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: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Spring 2018 Participation
Students in this arm (40 per school, up to 120 total) will participate in the BOKS program in Winter-Spring 2018.
They will serve as the control group in Fall 2018.
|
12-week physical activity program, occurring 3x/week, lasting 30-60 minutes per session.
|
|
Experimental: Fall 2018 Participation
Students in this arm (40 per school, up to 120 total) will participate in the BOKS program in Fall 2018.
|
12-week physical activity program, occurring 3x/week, lasting 30-60 minutes per session.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Body Mass Index (kg/m^2)
Time Frame: Baseline, Follow-up for each session (12 weeks)
|
calculated from height and weight
|
Baseline, Follow-up for each session (12 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Executive Function
Time Frame: Baseline, Follow-up for each session (12 weeks)
|
Executive function and attention/concentration as measured by the Flanker Task
|
Baseline, Follow-up for each session (12 weeks)
|
|
Change in Quality of Life PedsQL
Time Frame: Baseline, Follow-up for each session (12 weeks)
|
Measured by PedsQL, a validated measure of pediatric self-rated quality of life with higher score indicating higher quality of life.
|
Baseline, Follow-up for each session (12 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Elsie Taveras, MD, MGH
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)
February 16, 2018
Primary Completion (Actual)
December 30, 2018
Study Completion (Actual)
December 30, 2018
Study Registration Dates
First Submitted
January 11, 2019
First Submitted That Met QC Criteria
January 14, 2019
First Posted (Actual)
January 15, 2019
Study Record Updates
Last Update Posted (Estimated)
December 23, 2025
Last Update Submitted That Met QC Criteria
December 19, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017P002770
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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