- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03190135
Evaluation of the BOKS Before-school Physical Activity Program
June 15, 2017 updated by: Elsie Taveras, MD, Massachusetts General Hospital
Evaluation of the Build Our Kids' Success (BOKS) Before-school Physical Activity Program
BOKS, Build Our Kids' Success, is a before-school physical activity program that has been implemented in over 2,000 elementary and middle schools.
Students participate in the program for 12 weeks, two or three mornings per week for about 1 hour per session.
This study if a non-randomized control trial seeking to 1) examine the extent to which participation in the before-school BOKS program improves, health, well-being, and performance, and 2) compare the results of a two-day-per-week versus a three-day-per-week program.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
1250
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
-
Plymouth, Massachusetts, United States, 02360
- Plymouth Public Schools
-
Quincy, Massachusetts, United States, 02169
- Quincy Public Schools
-
Weymouth, Massachusetts, United States, 02190
- Weymouth Public Schools
-
-
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
5 years to 14 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participating school
- Child age 5-14 years
Exclusion Criteria:
- No valid parental consent
- Missing group assignment
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: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: BOKS: 2 day per week
|
Students participate in BOKS, a before-school physical activity program for 12 weeks, 2 times per week.
|
EXPERIMENTAL: BOKS: 3 day per week
|
Students participate in BOKS, a before-school physical activity program for 12 weeks, 3 times per week.
|
NO_INTERVENTION: Non-BOKS
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline Body Mass Index at 12 weeks
Time Frame: baseline, 12 weeks
|
Body Mass Index (kg/m^2): calculated from height and weight
|
baseline, 12 weeks
|
Change from baseline Body Mass Index Z-score at 12 weeks
Time Frame: baseline, 12 weeks
|
Age- and sex- specific Body Mass Index Z-score
|
baseline, 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline 400 meter run time at 12 weeks
Time Frame: baseline, 12 weeks
|
Time (seconds) to complete a 400 meter run
|
baseline, 12 weeks
|
Change from baseline physical activity at 12 weeks
Time Frame: baseline, 12 weeks
|
Days per week of physical activity
|
baseline, 12 weeks
|
Change from baseline peer relationships at 12 weeks
Time Frame: baseline, 12 weeks
|
PROMIS validated scale
|
baseline, 12 weeks
|
Change from baseline positive affect at 12 weeks
Time Frame: baseline, 12 weeks
|
PROMIS validated scale
|
baseline, 12 weeks
|
Change from baseline life satisfaction at 12 weeks
Time Frame: baseline, 12 weeks
|
PROMIS validated scale
|
baseline, 12 weeks
|
Change from baseline vitality/energy at 12 weeks
Time Frame: baseline, 12 weeks
|
Healthy Pathways Child-Report Scales
|
baseline, 12 weeks
|
Change from baseline student engagement at 12 weeks
Time Frame: baseline, 12 weeks
|
Healthy Pathways Child-Report Scales
|
baseline, 12 weeks
|
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.
General Publications
- Pojednic R, Peabody S, Carson S, Kennedy M, Bevans K, Phillips EM. The effect of before school physical activity on child development: A study protocol to evaluate the Build Our Kids Success (BOKS) Program. Contemp Clin Trials. 2016 Jul;49:103-8. doi: 10.1016/j.cct.2016.06.009. Epub 2016 Jun 23.
- Whooten RC, Perkins ME, Gerber MW, Taveras EM. Effects of Before-School Physical Activity on Obesity Prevention and Wellness. Am J Prev Med. 2018 Apr;54(4):510-518. doi: 10.1016/j.amepre.2018.01.017. Epub 2018 Feb 12.
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)
September 1, 2015
Primary Completion (ACTUAL)
May 31, 2016
Study Completion (ACTUAL)
May 31, 2016
Study Registration Dates
First Submitted
June 9, 2017
First Submitted That Met QC Criteria
June 15, 2017
First Posted (ACTUAL)
June 16, 2017
Study Record Updates
Last Update Posted (ACTUAL)
June 16, 2017
Last Update Submitted That Met QC Criteria
June 15, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017P000177
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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