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Evaluation of the BOKS Before-school Physical Activity Program

Primary Purpose

Overweight and Obesity, Affect, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BOKS: 2 day a week before-school physical activity program
BOKS: 3 day a week before-school physical activity program
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight and Obesity focused on measuring Overweight, Obesity, School, Physical Activity

Eligibility Criteria

5 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participating school
  • Child age 5-14 years

Exclusion Criteria:

  • No valid parental consent
  • Missing group assignment

Sites / Locations

  • Plymouth Public Schools
  • Quincy Public Schools
  • Weymouth Public Schools

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

BOKS: 2 day per week

BOKS: 3 day per week

Non-BOKS

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline Body Mass Index at 12 weeks
Body Mass Index (kg/m^2): calculated from height and weight
Change from baseline Body Mass Index Z-score at 12 weeks
Age- and sex- specific Body Mass Index Z-score

Secondary Outcome Measures

Change from baseline 400 meter run time at 12 weeks
Time (seconds) to complete a 400 meter run
Change from baseline physical activity at 12 weeks
Days per week of physical activity
Change from baseline peer relationships at 12 weeks
PROMIS validated scale
Change from baseline positive affect at 12 weeks
PROMIS validated scale
Change from baseline life satisfaction at 12 weeks
PROMIS validated scale
Change from baseline vitality/energy at 12 weeks
Healthy Pathways Child-Report Scales
Change from baseline student engagement at 12 weeks
Healthy Pathways Child-Report Scales

Full Information

First Posted
June 9, 2017
Last Updated
June 15, 2017
Sponsor
Massachusetts General Hospital
Collaborators
Reeboks BOKS
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1. Study Identification

Unique Protocol Identification Number
NCT03190135
Brief Title
Evaluation of the BOKS Before-school Physical Activity Program
Official Title
Evaluation of the Build Our Kids' Success (BOKS) Before-school Physical Activity Program
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
May 31, 2016 (Actual)
Study Completion Date
May 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Reeboks 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
BOKS, Build Our Kids' Success, is a before-school physical activity program that has been implemented in over 2,000 elementary and middle schools. Students participate in the program for 12 weeks, two or three mornings per week for about 1 hour per session. This study if a non-randomized control trial seeking to 1) examine the extent to which participation in the before-school BOKS program improves, health, well-being, and performance, and 2) compare the results of a two-day-per-week versus a three-day-per-week program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Affect, Physical Activity, Fitness
Keywords
Overweight, Obesity, School, Physical Activity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BOKS: 2 day per week
Arm Type
Experimental
Arm Title
BOKS: 3 day per week
Arm Type
Experimental
Arm Title
Non-BOKS
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
BOKS: 2 day a week before-school physical activity program
Intervention Description
Students participate in BOKS, a before-school physical activity program for 12 weeks, 2 times per week.
Intervention Type
Behavioral
Intervention Name(s)
BOKS: 3 day a week before-school physical activity program
Intervention Description
Students participate in BOKS, a before-school physical activity program for 12 weeks, 3 times per week.
Primary Outcome Measure Information:
Title
Change from baseline Body Mass Index at 12 weeks
Description
Body Mass Index (kg/m^2): calculated from height and weight
Time Frame
baseline, 12 weeks
Title
Change from baseline Body Mass Index Z-score at 12 weeks
Description
Age- and sex- specific Body Mass Index Z-score
Time Frame
baseline, 12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline 400 meter run time at 12 weeks
Description
Time (seconds) to complete a 400 meter run
Time Frame
baseline, 12 weeks
Title
Change from baseline physical activity at 12 weeks
Description
Days per week of physical activity
Time Frame
baseline, 12 weeks
Title
Change from baseline peer relationships at 12 weeks
Description
PROMIS validated scale
Time Frame
baseline, 12 weeks
Title
Change from baseline positive affect at 12 weeks
Description
PROMIS validated scale
Time Frame
baseline, 12 weeks
Title
Change from baseline life satisfaction at 12 weeks
Description
PROMIS validated scale
Time Frame
baseline, 12 weeks
Title
Change from baseline vitality/energy at 12 weeks
Description
Healthy Pathways Child-Report Scales
Time Frame
baseline, 12 weeks
Title
Change from baseline student engagement at 12 weeks
Description
Healthy Pathways Child-Report Scales
Time Frame
baseline, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participating school Child age 5-14 years Exclusion Criteria: No valid parental consent Missing group assignment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elsie Taveras, MD, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Plymouth Public Schools
City
Plymouth
State/Province
Massachusetts
ZIP/Postal Code
02360
Country
United States
Facility Name
Quincy Public Schools
City
Quincy
State/Province
Massachusetts
ZIP/Postal Code
02169
Country
United States
Facility Name
Weymouth Public Schools
City
Weymouth
State/Province
Massachusetts
ZIP/Postal Code
02190
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27339866
Citation
Pojednic R, Peabody S, Carson S, Kennedy M, Bevans K, Phillips EM. The effect of before school physical activity on child development: A study protocol to evaluate the Build Our Kids Success (BOKS) Program. Contemp Clin Trials. 2016 Jul;49:103-8. doi: 10.1016/j.cct.2016.06.009. Epub 2016 Jun 23.
Results Reference
background
PubMed Identifier
29449135
Citation
Whooten RC, Perkins ME, Gerber MW, Taveras EM. Effects of Before-School Physical Activity on Obesity Prevention and Wellness. Am J Prev Med. 2018 Apr;54(4):510-518. doi: 10.1016/j.amepre.2018.01.017. Epub 2018 Feb 12.
Results Reference
derived

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Evaluation of the BOKS Before-school Physical Activity Program

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