Back to resultsImplementation and Evaluation of a Before School Physical Activity Program in Revere, MA
Primary Purpose
Overweight and Obesity, Physical Activity, Quality of Life
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BOKS Program
Sponsored by
About this trial
This is an interventional prevention trial for Overweight and Obesity
Eligibility Criteria
Inclusion Criteria:
- Enrolled in the BOKS program
- Participating school
- Age 5-14
Exclusion Criteria:
- No valid consent
- Not enrolled in BOKS
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Spring 2018 Participation
Fall 2018 Participation
Arm Description
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.
Students in this arm (40 per school, up to 120 total) will participate in the BOKS program in Fall 2018.
Outcomes
Primary Outcome Measures
Change in Body Mass Index (kg/m^2)
calculated from height and weight
Secondary Outcome Measures
Change in Executive Function
Executive function and attention/concentration as measured by the Flanker Task
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.
Full Information
NCT ID
NCT03805295
First Posted
January 11, 2019
Last Updated
January 14, 2019
Sponsor
Massachusetts General Hospital
Collaborators
American Council on Exercise, BOKS
1. Study Identification
Unique Protocol Identification Number
NCT03805295
Brief Title
Implementation and Evaluation of a Before School Physical Activity Program in Revere, MA
Official Title
Implementation and Evaluation of a Before School Physical Activity Program in Revere, MA
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 16, 2018 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
American Council on Exercise, BOKS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Physical Activity, Quality of Life, Fitness, Executive Function
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spring 2018 Participation
Arm Type
Experimental
Arm Description
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.
Arm Title
Fall 2018 Participation
Arm Type
Experimental
Arm Description
Students in this arm (40 per school, up to 120 total) will participate in the BOKS program in Fall 2018.
Intervention Type
Other
Intervention Name(s)
BOKS Program
Intervention Description
12-week physical activity program, occurring 3x/week, lasting 30-60 minutes per session.
Primary Outcome Measure Information:
Title
Change in Body Mass Index (kg/m^2)
Description
calculated from height and weight
Time Frame
Baseline, Follow-up for each session (12 weeks)
Secondary Outcome Measure Information:
Title
Change in Executive Function
Description
Executive function and attention/concentration as measured by the Flanker Task
Time Frame
Baseline, Follow-up for each session (12 weeks)
Title
Change in Quality of life PedsQL
Description
Measured by PedsQL, a validated measure of pediatric self-rated quality of life with higher score indicating higher quality of life.
Time Frame
Baseline, Follow-up for each session (12 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Enrolled in the BOKS program
Participating school
Age 5-14
Exclusion Criteria:
No valid consent
Not enrolled in BOKS
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elsie Taveras, MD
Organizational Affiliation
MGH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Implementation and Evaluation of a Before School Physical Activity Program in Revere, MA
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