Overweight and ObesityNCT03190135
Evaluation of the BOKS Before-school Physical Activity Program
A study testing BOKS: 2 day a week before-school physical activity program and BOKS: 3 day a week before-school physical activity program in people with Overweight and Obesity and Affect, run by Massachusetts General Hospital at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Overweight and Obesity, Affect, Physical Activity
- What is being tested?
- BOKS: 2 day a week before-school physical activity program and BOKS: 3 day a week 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
- 1,250 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Sep 2015to 31 May 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participating school
- Child age 5-14 years
Who cannot join
- No valid parental consent
- Missing group assignment
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Plymouth Public Schools
Plymouth, Massachusetts, 02360
Quincy Public Schools
Quincy, Massachusetts, 02169
Weymouth Public Schools
Weymouth, Massachusetts, 02190
About this study
Official title: Evaluation of the Build Our Kids' Success (BOKS) Before-school Physical Activity Program
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.
- Conditions
- Overweight and Obesity, Affect, Physical Activity, Fitness
- Being tested
- BOKS: 2 day a week before-school physical activity program, BOKS: 3 day a week before-school physical activity program
- Keywords
- Overweight, Obesity, School, Physical Activity
- Medical subject headings
- Overweight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOKS: 2 day a week before-school physical activity programBehavioural
Students participate in BOKS, a before-school physical activity program for 12 weeks, 2 times per week.
BOKS: 3 day a week before-school physical activity programBehavioural
Students participate in BOKS, a before-school physical activity program for 12 weeks, 3 times per week.
| Study group | Role | What they receive |
|---|---|---|
| BOKS: 2 day per week | Experimental | Not described Receives: Behavioral: BOKS: 2 day a week before-school physical activity program |
| BOKS: 3 day per week | Experimental | Not described Receives: Behavioral: BOKS: 3 day a week before-school physical activity program |
| Non-BOKS | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Body Mass Index at 12 weeks
Body Mass Index (kg/m^2): calculated from height and weight
Measured: baseline, 12 weeks
Change from baseline Body Mass Index Z-score at 12 weeks
Age- and sex- specific Body Mass Index Z-score
Measured: baseline, 12 weeks
Secondary outcomes (7)
Change from baseline 400 meter run time at 12 weeks
Time (seconds) to complete a 400 meter run
Measured: baseline, 12 weeks
Change from baseline physical activity at 12 weeks
Days per week of physical activity
Measured: baseline, 12 weeks
Change from baseline peer relationships at 12 weeks
PROMIS validated scale
Measured: baseline, 12 weeks
Change from baseline positive affect at 12 weeks
PROMIS validated scale
Measured: baseline, 12 weeks
Change from baseline life satisfaction at 12 weeks
PROMIS validated scale
Measured: baseline, 12 weeks
Change from baseline vitality/energy at 12 weeks
Healthy Pathways Child-Report Scales
Measured: baseline, 12 weeks
Change from baseline student engagement at 12 weeks
Healthy Pathways Child-Report Scales
Measured: baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start1 Sep 2015
- Primary completion31 May 2016
- Study completion31 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- 1,250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Reeboks BOKS
- Responsible party
- Principal investigator, Elsie Taveras, MD, Massachusetts General Hospital
- Investigators
- Elsie Taveras, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03190135
- Sponsor's protocol ID
- 2017P000177
- Status last verified
- Jun 2017
- First submitted
- 9 Jun 2017
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27339866Whooten 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.
PubMed 29449135
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Build Our Kids' Success (BOKS) Before-school Physical Activity Program
- ClinicalTrials.gov ID
- NCT03190135
- Acronym / sponsor ID
- 2017P000177
- Conditions
- Overweight and Obesity, Affect, Physical Activity, Fitness
- Keywords
- Overweight, Obesity, School, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,250 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Reeboks BOKS
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 31 May 2016 (actual)
- Study completion
- 31 May 2016 (actual)
- First posted
- 16 Jun 2017 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BOKS: 2 day per week | Experimental | Behavioral: BOKS: 2 day a week before-school physical activity program |
| BOKS: 3 day per week | Experimental | Behavioral: BOKS: 3 day a week before-school physical activity program |
| Non-BOKS | No intervention | – |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Participating school
- Child age 5-14 years
Key exclusion criteria (2 listed)
- No valid parental consent
- Missing group assignment
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 |
|---|---|---|
| BOKS: 2 day a week before-school physical activity programStudents participate in BOKS, a before-school physical activity program for 12 weeks, 2 times per week. | Behavioural | BOKS: 2 day per week |
| BOKS: 3 day a week before-school physical activity programStudents participate in BOKS, a before-school physical activity program for 12 weeks, 3 times per week. | Behavioural | BOKS: 3 day per week |
Primary outcome
Change from baseline Body Mass Index at 12 weeks
Time frame: baseline, 12 weeks
Body Mass Index (kg/m^2): calculated from height and weight
Change from baseline Body Mass Index Z-score at 12 weeks
Time frame: baseline, 12 weeks
Age- and sex- specific Body Mass Index Z-score
7 secondary outcomes
Change from baseline 400 meter run time at 12 weeks
Time frame: baseline, 12 weeks
Change from baseline physical activity at 12 weeks
Time frame: baseline, 12 weeks
Change from baseline peer relationships at 12 weeks
Time frame: baseline, 12 weeks
Change from baseline positive affect at 12 weeks
Time frame: baseline, 12 weeks
Change from baseline life satisfaction at 12 weeks
Time frame: baseline, 12 weeks
Change from baseline vitality/energy at 12 weeks
Time frame: baseline, 12 weeks
Change from baseline student engagement at 12 weeks
Time frame: baseline, 12 weeks
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 16 Jun 2017.
- Background: PubMed 27339866Pojednic 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.
- Derived from this study: PubMed 29449135Whooten 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.
- 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.
Elsie Taveras, MD, MPH principal investigator
Massachusetts General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BOKS: 2 day a week before-school physical activity program and BOKS: 3 day a week before-school physical activity program in people with Overweight and Obesity and Affect, run by Massachusetts General Hospital at 3 sites in United States.
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 2 inclusion and 2 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 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change from baseline Body Mass Index at 12 weeks (time frame: baseline, 12 weeks). The study lists 2 primary outcomes in all. 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 NCT03190135, which also lists 2 linked publications.
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 16 Jun 2017.