Evaluation of the BOKS Before-school Physical Activity Program

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03190135

Collaborator

Reeboks BOKS (Other)

1,250

Enrollment

Locations

Arms

Actual Duration (Months)

416.7

Patients Per Site

46.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity Affect Physical Activity Fitness	Behavioral: BOKS: 2 day a week before-school physical activity program Behavioral: BOKS: 3 day a week before-school physical activity program	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

1250 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Evaluation of the Build Our Kids' Success (BOKS) Before-school Physical Activity Program

Actual Study Start Date :

Sep 1, 2015

Actual Primary Completion Date :

May 31, 2016

Actual Study Completion Date :

May 31, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BOKS: 2 day per week	Behavioral: BOKS: 2 day a week before-school physical activity program Students participate in BOKS, a before-school physical activity program for 12 weeks, 2 times per week.
Experimental: BOKS: 3 day per week	Behavioral: BOKS: 3 day a week before-school physical activity program Students participate in BOKS, a before-school physical activity program for 12 weeks, 3 times per week.
No Intervention: Non-BOKS

Arm

Intervention/Treatment

Experimental: BOKS: 2 day per week

Behavioral: BOKS: 2 day a week before-school physical activity program

Students participate in BOKS, a before-school physical activity program for 12 weeks, 2 times per week.

Experimental: BOKS: 3 day per week

Behavioral: BOKS: 3 day a week before-school physical activity program

Students participate in BOKS, a before-school physical activity program for 12 weeks, 3 times per week.

No Intervention: Non-BOKS

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Participating school
Child age 5-14 years

Exclusion Criteria:

No valid parental consent
Missing group assignment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Plymouth Public Schools	Plymouth	Massachusetts	United States	02360
2	Quincy Public Schools	Quincy	Massachusetts	United States	02169
3	Weymouth Public Schools	Weymouth	Massachusetts	United States	02190