- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03403816
Objective Assessment of Physical Activity in Before-school Physical Activity Programs (BOKS)
January 11, 2018 updated by: Angie Cradock, Harvard School of Public Health (HSPH)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
432
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 12 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Attending public elementary and middle school in two selected Massachusetts communities with BOKS programming
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Intervention
Students in grades K-6 at 7 schools in two communities participating in 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. . |
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.
Other Names:
|
|
NO_INTERVENTION: Comparison
Students in grades K-6 at the same 7 schools in two communities as the intervention participants, but who did not participate in the before school physical activity program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total steps per day
Time Frame: Participants wore a Fitbit activity monitor for up to 5 school days beginning with the before school period simultaneously for 24 hours/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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Active minutes
Time Frame: Participants wore a Fitbit activity monitor for up to 5 school days beginning with the before school period simultaneously for 24 hours/day
|
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
|
|
Sleep duration
Time Frame: Participants wore Fitbit activity monitors for 24 hours for up to 5 school days
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 17, 2016
Primary Completion (ACTUAL)
December 16, 2016
Study Completion (ACTUAL)
December 16, 2016
Study Registration Dates
First Submitted
December 20, 2017
First Submitted That Met QC Criteria
January 11, 2018
First Posted (ACTUAL)
January 19, 2018
Study Record Updates
Last Update Posted (ACTUAL)
January 19, 2018
Last Update Submitted That Met QC Criteria
January 11, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 16-1224
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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