Reducing Sedentary Time in Obese Adults (Study 2)

Obesity Clinical Trial

— B-MOBILE  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02160834
• Other study ID #: 1R03KD095740-02
• Secondary ID: R03DK095740
• Status: Withdrawn
• Phase: N/A
• First received: June 9, 2014
• Last updated: March 19, 2015
• Start date: January 2014
• Est. completion date: December 2014

Study information

• Verified date: June 2014
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: National Institutes of Health
• 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• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria:

• Bariatric surgery patients and other obese individuals will be considered

• Body mass index >= 25 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• B-MOBILE Smartphone-Based Intervention (3-min break)
Participants will receive a smartphone with B-MOBILE app that automatically monitors their sedentary time and prompts them after every 30 continuous sedentary minutes to walk for at least 3 minutes. Participants who meet this goal will receive reinforcing feedback in "real time."
• B-MOBILE Smartphone-Based Intervention (6-min break)
Participants will receive a smartphone with B-MOBILE app that automatically monitors their sedentary time and prompts them after every 60 continuous sedentary minutes to walk for at least 6 minutes. Participants who meet this goal will receive reinforcing feedback in "real time."

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	Change in percentage of daily sedentary time from baseline to post-intervention.		8 weeks	No
Secondary	Change in percentage of daily sedentary time from baseline to follow-up		12 weeks	No