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Clinical Trials/NCT03805295
NCT03805295CompletedNot Applicable

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

Massachusetts General Hospital2 sites in 1 country188 target enrollmentStarted: February 16, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
188
Locations
2
Primary Endpoint
Change in Body Mass Index (kg/m^2)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
5 Years to 14 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Enrolled in the BOKS program
  • Participating school

Exclusion Criteria

  • No valid consent
  • Not enrolled in BOKS

Arms & Interventions

Spring 2018 Participation

Experimental

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.

Intervention: BOKS Program (Other)

Fall 2018 Participation

Experimental

Students in this arm (40 per school, up to 120 total) will participate in the BOKS program in Fall 2018.

Intervention: BOKS Program (Other)

Outcomes

Primary Outcomes

Change in Body Mass Index (kg/m^2)

Time Frame: Baseline, Follow-up for each session (12 weeks)

calculated from height and weight

Secondary Outcomes

  • Change in Executive Function(Baseline, Follow-up for each session (12 weeks))
  • Change in Quality of Life PedsQL(Baseline, Follow-up for each session (12 weeks))
  • Change in Executive Function(Baseline, Follow-up for each session (12 weeks))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Elsie Taveras, MD

Chief, Division of General Pediatrics

Massachusetts General Hospital

Study Sites (2)

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