B-MOBILE: Reducing Sedentary Time in Obese Adults (Study 2)

Sponsor

The Miriam Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02160834

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Behavioral: B-MOBILE Smartphone-Based Intervention (3-min break) Behavioral: B-MOBILE Smartphone-Based Intervention (6-min break)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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."	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."
Experimental: 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."	Behavioral: 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."
No Intervention: Control

Arm

Intervention/Treatment

Experimental: 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."

Behavioral: B-MOBILE Smartphone-Based Intervention (3-min break)

Experimental: 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."

Behavioral: B-MOBILE Smartphone-Based Intervention (6-min break)

No Intervention: Control

Outcome Measures

Primary Outcome Measures

Change in percentage of daily sedentary time from baseline to post-intervention. [8 weeks]

Secondary Outcome Measures

Change in percentage of daily sedentary time from baseline to follow-up [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.