Clinical trial NCT03190135: 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
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Affect
Physical Activity
Fitness
Keywords: Overweight
Obesity
School
Physical Activity
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Reeboks BOKS
First posted: 2017-06-16
Enrollment: 1250
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* Participating school
* Child age 5-14 years

Exclusion Criteria:

* No valid parental consent
* Missing group assignment

Primary outcomes:
measure: Change from baseline Body Mass Index at 12 weeks
timeFrame: baseline, 12 weeks
measure: Change from baseline Body Mass Index Z-score at 12 weeks
timeFrame: baseline, 12 weeks
Secondary outcomes:
measure: Change from baseline 400 meter run time at 12 weeks
timeFrame: baseline, 12 weeks
measure: Change from baseline physical activity at 12 weeks
timeFrame: baseline, 12 weeks
measure: Change from baseline peer relationships at 12 weeks
timeFrame: baseline, 12 weeks
measure: Change from baseline positive affect at 12 weeks
timeFrame: baseline, 12 weeks
measure: Change from baseline life satisfaction at 12 weeks
timeFrame: baseline, 12 weeks
measure: Change from baseline vitality/energy at 12 weeks
timeFrame: baseline, 12 weeks
measure: Change from baseline student engagement at 12 weeks
timeFrame: baseline, 12 weeks
Other outcomes:
Locations:
city: Plymouth
country: United States
facility: Plymouth Public Schools
state: Massachusetts
city: Quincy
country: United States
facility: Quincy Public Schools
state: Massachusetts
city: Weymouth
country: United States
facility: Weymouth Public Schools
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Elsie Taveras, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.