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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03805295
Other study ID # 2017P002770
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 16, 2018
Est. completion date December 30, 2018

Study information

Verified date January 2019
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 128
Est. completion date December 30, 2018
Est. primary completion date December 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 14 Years
Eligibility Inclusion Criteria:

- Enrolled in the BOKS program

- Participating school

- Age 5-14

Exclusion Criteria:

- No valid consent

- Not enrolled in BOKS

Study Design


Intervention

Other:
BOKS Program
12-week physical activity program, occurring 3x/week, lasting 30-60 minutes per session.

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (3)

Lead Sponsor Collaborator
Massachusetts General Hospital American Council on Exercise, BOKS

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Body Mass Index (kg/m^2) calculated from height and weight Baseline, Follow-up for each session (12 weeks)
Secondary Change in Executive Function Executive function and attention/concentration as measured by the Flanker Task Baseline, Follow-up for each session (12 weeks)
Secondary Change in Quality of life PedsQL 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)
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