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

Primary Purpose

Obesity, Overweight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
built environment use counseling
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obesity focused on measuring Obesity, Overweight, Physical Activity, Built Environment, counseling

Eligibility Criteria

10 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital Revere HealthCare Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

standard physical activity counseling

built environment use counseling

Arm Description

personalized counseling on active use of the built environment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 3, 2013
Last Updated
August 31, 2017
Sponsor
Massachusetts General Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT01939405
Brief Title
Children's Use of the Built Environment for Physical Activity
Acronym
CUBES
Official Title
Use of the Built Environment to Promote Physical Activity in Children.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
Obesity, Overweight, Physical Activity, Built Environment, counseling

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
standard physical activity counseling
Arm Type
No Intervention
Arm Title
built environment use counseling
Arm Type
Experimental
Arm Description
personalized counseling on active use of the built environment
Intervention Type
Behavioral
Intervention Name(s)
built environment use counseling
Primary Outcome Measure Information:
Title
Moderate to Vigorous Physical Activity (MVPA)
Description
Short-term change in MVPA from baseline to post-intervention
Time Frame
Immediately post-intervention
Secondary Outcome Measure Information:
Title
Moderate-to-Vigorous Physical Activity (MVPA)
Description
Longer term change in MVPA from baseline to 3-4 months post intervention
Time Frame
4 months from baseline
Title
Sedentary Time
Description
Short-term change in sedentary (non-active) time from baseline to post-intervention, objectively measured using accelerometers
Time Frame
Immediately post-intervention
Title
Sedentary Time
Description
Longer-term change in sedentary (non-active) time from baseline to 3-4 months post-intervention, objectively measured using accelerometers.
Time Frame
4 months from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas M Oreskovic, MD, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital Revere HealthCare Center
City
Revere
State/Province
Massachusetts
ZIP/Postal Code
02151
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27235377
Citation
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.
Results Reference
derived

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Children's Use of the Built Environment for Physical Activity

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