Evaluation of the BOKS Before-school Physical Activity Program

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03190135
• Other study ID #: 2017P000177
• Status: Completed
• Phase: N/A
• First received: June 9, 2017
• Last updated: June 15, 2017
• Start date: September 1, 2015
• Est. completion date: May 31, 2016

Study information

• Verified date: June 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1250
• Est. completion date: May 31, 2016
• Est. primary completion date: May 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 14 Years

Eligibility

Inclusion Criteria:

• Participating school

• Child age 5-14 years

Exclusion Criteria:

• No valid parental consent

• Missing group assignment

Related Conditions & MeSH terms

• Affect
• Fitness
• Overweight
• Overweight and Obesity
• Physical Activity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Plymouth Public Schools	Plymouth	Massachusetts
United States	Quincy Public Schools	Quincy	Massachusetts
United States	Weymouth Public Schools	Weymouth	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Reeboks BOKS

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Body Mass Index at 12 weeks	Body Mass Index (kg/m^2): calculated from height and weight	baseline, 12 weeks
Primary	Change from baseline Body Mass Index Z-score at 12 weeks	Age- and sex- specific Body Mass Index Z-score	baseline, 12 weeks
Secondary	Change from baseline 400 meter run time at 12 weeks	Time (seconds) to complete a 400 meter run	baseline, 12 weeks
Secondary	Change from baseline physical activity at 12 weeks	Days per week of physical activity	baseline, 12 weeks
Secondary	Change from baseline peer relationships at 12 weeks	PROMIS validated scale	baseline, 12 weeks
Secondary	Change from baseline positive affect at 12 weeks	PROMIS validated scale	baseline, 12 weeks
Secondary	Change from baseline life satisfaction at 12 weeks	PROMIS validated scale	baseline, 12 weeks
Secondary	Change from baseline vitality/energy at 12 weeks	Healthy Pathways Child-Report Scales	baseline, 12 weeks
Secondary	Change from baseline student engagement at 12 weeks	Healthy Pathways Child-Report Scales	baseline, 12 weeks