Physical ActivityBOKSNCT03403816

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

A study testing Before School Physical Activity Program in people with Physical Activity and Sleep, run by Harvard School of Public Health (HSPH).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 5 to 12 yearsHealthy volunteers can take part
Conditions the study is for: Physical Activity, Sleep
What is being tested?: Before School Physical Activity Program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 432 participants
Where: No sites listed yet
Study dates: 17 Oct 2016to 16 Dec 2016
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 5 to 12 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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

Who cannot join

None

About this study

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.

Conditions: Physical Activity, Sleep
Being tested: Before School Physical Activity Program
Medical subject headings: Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Before School Physical Activity ProgramBehavioural
Also called Build Our Kids Success (BOKS)
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.

Study groups in NCT03403816
Study group	Role	What they receive
Intervention	Active comparator	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. . Receives: Behavioral: Before School Physical Activity Program
Comparison	No intervention	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 being measured

The primary outcome is the main question the study is designed to answer.

Total steps per day
The primary outcome measure is a physical activity measure of how many steps per day participants took.
Measured: 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 (2)

Active minutes
A secondary outcome measure is a measure of how many minutes participants spent in light, moderate and vigorous activity per day.
Measured: 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
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.
Measured: Participants wore Fitbit activity monitors for 24 hours for up to 5 school days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Oct 201616 Dec 2016

First posted19 Jan 2018
Study start17 Oct 2016
Primary completion16 Dec 2016
Study completion16 Dec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Physical ActivityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 432 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03403816
Sponsor's protocol ID: 16-1224
Acronym: BOKS
Status last verified: Jan 2018
First submitted: 20 Dec 2017
Last updated: 19 Jan 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Objective Assessment of Physical Activity in Before-school Physical Activity Programs
ClinicalTrials.gov ID: NCT03403816
Acronym / sponsor ID: BOKS / 16-1224
Conditions: Physical Activity, Sleep
Study type: Interventional
Recruitment status: Completed
Enrolment: 432 participants (actual)
Lead sponsor: Harvard School of Public Health (HSPH)University, hospital or other
Collaborators: Reebok Foundation, Massachusetts General Hospital
Study start: 17 Oct 2016 (actual)
Primary completion: 16 Dec 2016 (actual)
Study completion: 16 Dec 2016 (actual)
First posted: 19 Jan 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intervention	Active comparator	Behavioral: Before School Physical Activity ProgramStudents 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. .
Comparison	No intervention	–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.

Who may qualify

Ages: 5 to 12 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Before School Physical Activity ProgramAlso: Build Our Kids Success (BOKS)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.	Behavioural	Intervention

Primary outcome

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.

2 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2018.
Derived from this study: PubMed 31367511Cradock 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing Before School Physical Activity Program in people with Physical Activity and Sleep, run by Harvard School of Public Health (HSPH).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03403816, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2018.