ObesityCUBESNCT01939405

Children's Use of the Built Environment for Physical Activity

A study testing built environment use counseling in people with Obesity and Overweight, run by Massachusetts General Hospital at 1 site in United States.

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 10 to 16 years
Conditions the study is for: Obesity, Overweight
What is being tested?: built environment use counseling
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: Oct 2013to Jun 2015
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 10 to 16 years
All sexes
No healthy volunteers
Child

Who may be able to join

Adolescents ages 10-16 years
BMI > 85th percentile for age and sex

Who cannot join

Physical conditions impairing ambulation
Adolescents who do not speak English
Adolescents who have missed more than 2 scheduled doctor's appointments during the past 5 years
Adolescents who are receiving any other form of physical activity counseling/intervention at the time of enrollment

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital Revere HealthCare Center
Revere, Massachusetts, 02151

Other trials in United States

About this study

Official title: Use of the Built Environment to Promote Physical Activity in Children.

The study aims are to develop and test the feasibility of a pediatric physical activity intervention that incorporates personal information on use of the built environment, and test the intervention's preliminary efficacy at increasing physical activity. The investigators hypothesize that it will be feasible to incorporate and measure changes in empiric GIS (geographic information system), GPS (global positioning system), and accelerometer feedback in the office setting as demonstrated by: i) Completeness of GPS and accelerometer data collection (primary measure of feasibility), ii) Participation rates among adolescents in the intervention group compared to the control group, and iii) Acceptability to patients as measured by adolescent satisfaction.

Conditions: Obesity, Overweight
Being tested: built environment use counseling
Keywords: Obesity, Overweight, Physical Activity, Built Environment, counseling
Medical subject headings: Obesity, Overweight, Motor Activity

What participants receive

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

built environment use counselingBehavioural

Study groups in NCT01939405
Study group	Role	What they receive
standard physical activity counseling	No intervention	Not described
built environment use counseling	Experimental	personalized counseling on active use of the built environment Receives: Behavioral: built environment use counseling

What is being measured

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

Moderate to Vigorous Physical Activity (MVPA)
Short-term change in MVPA from baseline to post-intervention
Measured: Immediately post-intervention

Secondary outcomes (3)

Moderate-to-Vigorous Physical Activity (MVPA)
Longer term change in MVPA from baseline to 3-4 months post intervention
Measured: 4 months from baseline
Sedentary Time
Short-term change in sedentary (non-active) time from baseline to post-intervention, objectively measured using accelerometers
Measured: Immediately post-intervention
Sedentary Time
Longer-term change in sedentary (non-active) time from baseline to 3-4 months post-intervention, objectively measured using accelerometers.
Measured: 4 months from baseline

Timeline

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

Oct 2013Jun 2015

First posted11 Sep 2013 (estimated)
Study startOct 2013
Primary completionMay 2015
Study completionJun 2015

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for 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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01939405
Sponsor's protocol ID: 2010P001480
Other IDs: K23HL103841
Acronym: CUBES
Status last verified: Aug 2017
First submitted: 3 Sep 2013
Last updated: 2 Oct 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Oreskovic NM, Winickoff JP, Perrin JM, Robinson AI, Goodman E. A Multimodal Counseling-Based Adolescent Physical Activity Intervention. J Adolesc Health. 2016 Sep;59(3):332-337. doi: 10.1016/j.jadohealth.2016.03.012. Epub 2016 May 24.
PubMed 27235377

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Use of the Built Environment to Promote Physical Activity in Children.
ClinicalTrials.gov ID: NCT01939405
Acronym / sponsor ID: CUBES / 2010P001480
Conditions: Obesity, Overweight
Keywords: Obesity, Overweight, Physical Activity, Built Environment, counseling
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: Oct 2013
Primary completion: May 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 11 Sep 2013 (estimated)
Results: Posted 2 Oct 2017

Clinical summary

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

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
standard physical activity counseling	No intervention	–
built environment use counseling	Experimental	Behavioral: built environment use counselingpersonalized counseling on active use of the built environment

Who may qualify

Ages: 10 to 16 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

Adolescents ages 10-16 years
BMI > 85th percentile for age and sex

Key exclusion criteria (4 listed)

Physical conditions impairing ambulation
Adolescents who do not speak English
Adolescents who have missed more than 2 scheduled doctor's appointments during the past 5 years
Adolescents who are receiving any other form of physical activity counseling/intervention at the time of enrollment

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
built environment use counseling	Behavioural	built environment use counseling

Primary outcome

Moderate to Vigorous Physical Activity (MVPA)
Time frame: Immediately post-intervention
Short-term change in MVPA from baseline to post-intervention

3 secondary outcomes

Moderate-to-Vigorous Physical Activity (MVPA)
Time frame: 4 months from baseline
Sedentary Time
Time frame: Immediately post-intervention
Sedentary Time
Time frame: 4 months from baseline

Results and safety

Results posted to the registry on 2 Oct 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Physical Activity Counseling	30	27
Built Environment Use Counseling	30	28

Primary outcome: Moderate to Vigorous Physical Activity (MVPA)

Time frame: Immediately post-intervention. Median (Inter-Quartile Range). Unit: minutes

Measure	Standard Physical Activity Counseling n = 27	Built Environment Use Counseling n = 28
Value	-1.9 (-14.1 to 3.7)	1.07 (-14.7 to 21.4)

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Physical Activity Counseling	0 of 0	0 of 0	0
Built Environment Use Counseling	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): Small sample size, single office setting, short term (4 months) follow-up, multi-component intervention including financial incentives and text messages.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27235377Oreskovic NM, Winickoff JP, Perrin JM, Robinson AI, Goodman E. A Multimodal Counseling-Based Adolescent Physical Activity Intervention. J Adolesc Health. 2016 Sep;59(3):332-337. doi: 10.1016/j.jadohealth.2016.03.012. Epub 2016 May 24.

Related trials for Obesity

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
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Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)

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.

Nicolas M Oreskovic, MD, MPH principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing built environment use counseling in people with Obesity and Overweight, 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 2 inclusion and 4 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 2 Oct 2017. 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 2 Oct 2017). 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?

Moderate to Vigorous Physical Activity (MVPA) (time frame: Immediately post-intervention). 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 NCT01939405, 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 2 Oct 2017.