Overweight and ObesityNCT03805295
Implementation and Evaluation of a Before School Physical Activity Program in Revere, MA
A study testing BOKS Program in people with Overweight and Obesity and Physical Activity, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study evaluates the implementation of the BOKS program in three schools (K-8) in Revere, MA, and its effect on participating students with regard to BMI, cognitive, and quality of life outcomes. Read more about this study
- Who is it for?
- Ages 5 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Physical Activity, Quality of Life
- What is being tested?
- BOKS Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2018to 30 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Child
Who may be able to join
- Enrolled in the BOKS program
- Participating school
- Age 5-14
Who cannot join
- No valid consent
- Not enrolled in BOKS
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
This study evaluates the implementation of the BOKS program in three schools (K-8) in Revere, MA, and its effect on participating students with regard to BMI, cognitive, and quality of life outcomes. BOKS (Build Our Kids' Success) is a before-school physical activity program that has been implemented in over 2,000 elementary and middle schools. Two sessions will be held (Spring 2018 and Winter 2018. This is a cohort study evaluating the impact of program participation on child BMI, quality of life, and executive function.
- Being tested
- BOKS Program
- 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 ProgramOther
12-week physical activity program, occurring 3x/week, lasting 30-60 minutes per session.
| Study group | Role | What they receive |
|---|---|---|
| Spring 2018 Participation | Experimental | Students in this arm (40 per school, up to 120 total) will participate in the BOKS program in Winter-Spring 2018. They will serve as the control group in Fall 2018. Receives: Other: BOKS Program |
| Fall 2018 Participation | Experimental | Students in this arm (40 per school, up to 120 total) will participate in the BOKS program in Fall 2018. Receives: Other: BOKS Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index (kg/m^2)
calculated from height and weight
Measured: Baseline, Follow-up for each session (12 weeks)
Secondary outcomes (2)
Change in Executive Function
Executive function and attention/concentration as measured by the Flanker Task
Measured: Baseline, Follow-up for each session (12 weeks)
Change in Quality of Life PedsQL
Measured by PedsQL, a validated measure of pediatric self-rated quality of life with higher score indicating higher quality of life.
Measured: Baseline, Follow-up for each session (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start16 Feb 2018
- Primary completion30 Dec 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Council on Exercise, BOKS
- Responsible party
- Principal investigator, Elsie Taveras, MD, Massachusetts General Hospital
- Investigators
- Elsie Taveras, MD, Principal investigator, MGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03805295
- Sponsor's protocol ID
- 2017P002770
- Status last verified
- Dec 2025
- First submitted
- 11 Jan 2019
- Last updated
- 23 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Evaluation of a Before School Physical Activity Program in Revere, MA
- ClinicalTrials.gov ID
- NCT03805295
- Acronym / sponsor ID
- 2017P002770
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- American Council on Exercise, BOKS
- Study start
- 16 Feb 2018 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 15 Jan 2019 (actual)
- Results
- Posted 23 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the implementation of the BOKS program in three schools (K-8) in Revere, MA, and its effect on participating students with regard to BMI, cognitive, and quality of life outcomes. BOKS (Build Our Kids' Success) is a before-school physical activity program that has been implemented in over 2,000 elementary and middle schools. Two sessions will be held (Spring 2018 and Winter 2018. This is a cohort study evaluating the impact of program participation on child BMI, quality of life, and executive function.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spring 2018 Participation | Experimental | Other: BOKS ProgramStudents in this arm (40 per school, up to 120 total) will participate in the BOKS program in Winter-Spring 2018. They will serve as the control group in Fall 2018. |
| Fall 2018 Participation | Experimental | Other: BOKS ProgramStudents in this arm (40 per school, up to 120 total) will participate in the BOKS program in Fall 2018. |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Enrolled in the BOKS program
- Participating school
- Age 5-14
Key exclusion criteria (2 listed)
- No valid consent
- Not enrolled in BOKS
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 Program12-week physical activity program, occurring 3x/week, lasting 30-60 minutes per session. | Other | Fall 2018 Participation, Spring 2018 Participation |
Primary outcome
Change in Body Mass Index (kg/m^2)
Time frame: Baseline, Follow-up for each session (12 weeks)
calculated from height and weight
2 secondary outcomes
Change in Executive Function
Time frame: Baseline, Follow-up for each session (12 weeks)
Change in Quality of Life PedsQL
Time frame: Baseline, Follow-up for each session (12 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 principal investigator
MGH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BOKS Program in people with Overweight and Obesity and Physical Activity, run by Massachusetts General Hospital at 1 site 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 3 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 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 23 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in Body Mass Index (kg/m^2) (time frame: Baseline, Follow-up for each session (12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Dec 2025.