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Children's Use of the Built Environment for Physical Activity (CUBES)

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ClinicalTrials.gov Identifier: NCT01939405
Recruitment Status : Completed
First Posted : September 11, 2013
Results First Posted : October 2, 2017
Last Update Posted : October 2, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Nicolas M. Oreskovic, MD, MPH, Massachusetts General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Overweight Behavioral: built environment use counseling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Use of the Built Environment to Promote Physical Activity in Children.
Study Start Date : October 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: standard physical activity counseling
Experimental: built environment use counseling
personalized counseling on active use of the built environment
Behavioral: built environment use counseling



Primary Outcome Measures :
  1. Moderate to Vigorous Physical Activity (MVPA) [ Time Frame: Immediately post-intervention ]
    Short-term change in MVPA from baseline to post-intervention


Secondary Outcome Measures :
  1. Moderate-to-Vigorous Physical Activity (MVPA) [ Time Frame: 4 months from baseline ]
    Longer term change in MVPA from baseline to 3-4 months post intervention

  2. Sedentary Time [ Time Frame: Immediately post-intervention ]
    Short-term change in sedentary (non-active) time from baseline to post-intervention, objectively measured using accelerometers

  3. Sedentary Time [ Time Frame: 4 months from baseline ]
    Longer-term change in sedentary (non-active) time from baseline to 3-4 months post-intervention, objectively measured using accelerometers.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939405


Locations
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United States, Massachusetts
Massachusetts General Hospital Revere HealthCare Center
Revere, Massachusetts, United States, 02151
Sponsors and Collaborators
Massachusetts General Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Nicolas M Oreskovic, MD, MPH Massachusetts General Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nicolas M. Oreskovic, MD, MPH, Physician, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01939405     History of Changes
Other Study ID Numbers: 2010P001480
K23HL103841 ( U.S. NIH Grant/Contract )
First Posted: September 11, 2013    Key Record Dates
Results First Posted: October 2, 2017
Last Update Posted: October 2, 2017
Last Verified: August 2017

Keywords provided by Nicolas M. Oreskovic, MD, MPH, Massachusetts General Hospital:
Obesity
Overweight
Physical Activity
Built Environment
counseling

Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms