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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03403816
Other study ID # 16-1224
Secondary ID
Status Completed
Phase N/A
First received December 20, 2017
Last updated January 11, 2018
Start date October 17, 2016
Est. completion date December 16, 2016

Study information

Verified date January 2018
Source Harvard School of Public Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will determine the effectiveness of a free before-school physical activity program, BOKS (Build Our Kids' Success), in increasing objectively measured physical activity levels among children in elementary and middle school in 7 schools in Massachusetts.


Description:

This study will determine the effectiveness of a free before-school physical activity program, BOKS (Build Our Kids' Success), in increasing objectively measured physical activity levels among children in elementary and middle school in 7 schools in Massachusetts. The study focuses on capturing valid and objective assessments of student-level physical activity during BOKS program time and assessing the impact of the BOKS program on overall daily physical activity levels using minute-by-minute physical activity level data among elementary aged students. Data is also collected to understand how increasing physical activity may impact students' sleep.


Recruitment information / eligibility

Status Completed
Enrollment 432
Est. completion date December 16, 2016
Est. primary completion date December 16, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 12 Years
Eligibility Inclusion Criteria:

- Attending public elementary and middle school in two selected Massachusetts communities with BOKS programming

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Before School Physical Activity Program
BOKS is a before school physical activity program offered at no cost to participating families that focuses on engaging elementary and middle school students in physical activity, skill development and brief nutrition education sessions that prepare them for a day of learning. The BOKS curriculum includes 12 weeks of instruction and 40 minutes of structured kid-friendly activities that include warm-ups, skill of the week, running, relay and obstacle course activities and nutritional tips. The BOKS team provides training for BOKS leaders free of charge each month. BOKS is currently being used in more than 1,800 schools in the US and Canada.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Harvard School of Public Health Massachusetts General Hospital, Reebok Foundation

Outcome

Type Measure Description Time frame Safety issue
Primary Total steps per day The primary outcome measure is a physical activity measure of how many steps per day participants took. Participants wore a Fitbit activity monitor for up to 5 school days beginning with the before school period simultaneously for 24 hours/day
Secondary Active minutes A secondary outcome measure is a measure of how many minutes participants spent in light, moderate and vigorous activity per day. Participants wore a Fitbit activity monitor for up to 5 school days beginning with the before school period simultaneously for 24 hours/day
Secondary Sleep duration A secondary outcome measure is the amount of time participants spent asleep each night, measured by a Fitbit activity monitor, which collects a measure of total sleep time. Participants wore Fitbit activity monitors for 24 hours for up to 5 school days
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