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CompletedNCT03403816BOKSUpdated Jan 19, 2018

Objective Assessment of Physical Activity in Before-school Physical Activity Programs

An interventional study of Before School Physical Activity Program in Physical Activity and Sleep, sponsored by Harvard School of Public Health (HSPH). Completed. Open to participants aged 5 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-19.

Sponsored by Harvard School of Public Health (HSPH) · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Oct 2016, registered Dec 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
432
Allocation
Non-randomized
Ages
5 Years to 12 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Physical Activity
  • Sleep

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03

In context

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

This study's enrollment of 432 is above the median of 60 across 8,388 interventional studies indexed under Motor Activity.

Browse Motor Activity studies →

Lead sponsor

Harvard School of Public Health (HSPH) is the lead sponsor of 154 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
5 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • None
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
432 participants (actual)

Study arms

  • 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. .

    Behavioral: Before School Physical Activity Program

  • 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.

Interventions

  • BehavioralBefore 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.

    Also known as: Build Our Kids Success (BOKS)

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What researchers measure

Primary outcomes

  1. Total steps per day

    The primary outcome measure is a physical activity measure of how many steps per day participants took.

    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

Secondary outcomes

  1. Active minutes

    A secondary outcome measure is a measure of how many minutes participants spent in light, moderate and vigorous activity 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

  2. 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.

    Time frame: Participants wore Fitbit activity monitors for 24 hours for up to 5 school days

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Cradock AL, Barrett JL, Taveras EM, Peabody S, Flax CN, Giles CM, Gortmaker SL. Effects of a before-school program on student physical activity levels. Prev Med Rep. 2019 Jul 3;15:100940. doi: 10.1016/j.pmedr.2019.100940. eCollection 2019 Sep. PubMed 31367511 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2016 to primary completion in Dec 2016, 1 month.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 1 month is below that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 20, 2017
First posted
Jan 19, 2018
StartActual
Oct 17, 2016
Primary completionActual
Dec 16, 2016
CompletionActual
Dec 16, 2016
Last update
Jan 19, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03403816
Collaborators
Reebok Foundation, Massachusetts General Hospital
Responsible party
Angie Cradock (Senior Research Scientist, Harvard School of Public Health (HSPH)) — Principal investigator
First posted
Jan 19, 2018
Start date
Oct 17, 2016
Primary completion
Dec 16, 2016
Completion
Dec 16, 2016
Last update
Jan 19, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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