Implementation and Evaluation of a Before School Physical Activity Program in Revere, MA

Quality of Life Clinical Trial

Official title:

Implementation and Evaluation of a Before School Physical Activity Program in Revere, MA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03805295
• Other study ID #: 2017P002770
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Executive Function
• Fitness
• Overweight
• Overweight and Obesity
• Physical Activity
• Quality of Life

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)