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

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03805295
• Collaborator: American Council on Exercise (Other), BOKS (Other)
• Enrollment: 128
• Location: 1
• Arms: 2
• Actual Duration (Months): 10.4
• Patients Per Site Per Month: 12.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity; Physical Activity; Quality of Life; Fitness; Executive Function	Other: BOKS Program	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 128 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Implementation and Evaluation of a Before School Physical Activity Program in Revere, MA
• Actual Study Start Date: Feb 16, 2018
• Actual Primary Completion Date: Dec 30, 2018
• Actual Study Completion Date: Dec 30, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in Body Mass Index (kg/m^2) [Baseline, Follow-up for each session (12 weeks)]

   calculated from height and weight

Secondary Outcome Measures

1. Change in Executive Function [Baseline, Follow-up for each session (12 weeks)]

   Executive function and attention/concentration as measured by the Flanker Task

2. Change in Quality of life PedsQL [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 14 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Enrolled in the BOKS program

• Participating school

• Age 5-14

Exclusion Criteria:

• No valid consent

• Not enrolled in BOKS

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital
• American Council on Exercise
• BOKS

Investigators

• Principal Investigator: Elsie Taveras, MD, MGH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Elsie Taveras, MD, Chief, Division of General Pediatrics, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT03805295
• Other Study ID Numbers: 2017P002770
• First Posted: Jan 15, 2019
• Last Update Posted: Jan 15, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Overweight

Study Results

No Results Posted as of Jan 15, 2019