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NCT01688804 Clinical Trial

Reducing Sedentary Time in Obese Adults

Sedentary Behavior Clinical Trial

Official title:
A Mobile Health Approach to Reducing Sedentary Time in Bariatric Surgery Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01688804
Other study ID # 1R03DK095740-01
Secondary ID
Status Completed
Phase N/A
First received September 17, 2012
Last updated March 19, 2015
Start date February 2013
Est. completion date December 2014

Study information
Verified date September 2012
Source The Miriam Hospital
Contact n/a
Is FDA regulated No
Health authority United States: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases
Study type Interventional

Clinical Trial Summary

Greater time spent in sedentary behaviors, independent of physical activity level, can increase risk of morbidity and mortality. Objective assessments indicate that bariatric surgery patients spend large amounts of time in sedentary behaviors. The present study is the first to test whether a mobile health (mHealth) approach that employs widely adopted smartphone technology to monitor and modify sedentary behaviors as they occur is a feasible and acceptable method of reducing sedentary time in these patients and other obese populations.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years to 65 Years
Eligibility Inclusion Criteria:

- Bariatric surgery patients and other obese individuals will be considered

- Body mass index >= 30 kg/m2

Exclusion Criteria:

- Report being unable to engage in daily activities and walk continuously for >= 10 minutes without assistance

- Are currently involved in a physical activity intervention.

- Are unable to read or understand the study materials

- Are currently taking medications that cause dizziness and/or feeling faint when sitting or standing.

- Report any condition that in the opinion of investigators would preclude adherence to the intervention protocol including plans to relocate, history of substance abuse or other significant psychiatric problems, or terminal illness.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• Behavioral intervention to reduce sedentary time delivered via mobile smartphone
The overall goals of the intervention are to decrease overall sedentary time and to increase the number of breaks in sedentary time. The intervention approach combines an advanced smartphone device with an on-board accelerometer and a sophisticated smartphone application to: 1) monitor participants sedentary behavior in real time in their natural environment; and 2) use monitored data to deliver immediate, individually-tailored, goal-driven prompts and feedback to encourage substitute of sedentary behaviors with physical activity.

Locations
Country Name City State
United States The Weight Control and Diabetes Research Center Providence Rhode Island

Sponsors (2)
Lead Sponsor Collaborator
The Miriam Hospital National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Average daily sedentary minutes 4 weeks No
Secondary Average daily adherence to prompts to reduce sedentary time delivered via mobile smartphone 4 weeks No
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