Children's Use of the Built Environment for Physical Activity

Obesity Clinical Trial

— CUBES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01939405
• Other study ID #: 2010P001480
• Secondary ID: K23HL103841
• Status: Completed
• Phase: N/A
• First received: September 3, 2013
• Last updated: August 31, 2017
• Start date: October 2013
• Est. completion date: June 2015

Study information

• Verified date: August 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• built environment use counseling

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Revere HealthCare Center	Revere	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Moderate to Vigorous Physical Activity (MVPA)	Short-term change in MVPA from baseline to post-intervention	Immediately post-intervention
Secondary	Moderate-to-Vigorous Physical Activity (MVPA)	Longer term change in MVPA from baseline to 3-4 months post intervention	4 months from baseline
Secondary	Sedentary Time	Short-term change in sedentary (non-active) time from baseline to post-intervention, objectively measured using accelerometers	Immediately post-intervention
Secondary	Sedentary Time	Longer-term change in sedentary (non-active) time from baseline to 3-4 months post-intervention, objectively measured using accelerometers.	4 months from baseline