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

March 19, 2015 updated by: The Miriam Hospital

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • The Weight Control and Diabetes Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
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."

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in percentage of daily sedentary time from baseline to post-intervention.
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in percentage of daily sedentary time from baseline to follow-up
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Miriam Hospital

Collaborators

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

Investigators

  • Principal Investigator: Dale S Bond, PhD, The Miriam Hospital/Brown Alpert Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

June 9, 2014

First Submitted That Met QC Criteria

June 10, 2014

First Posted (Estimate)

June 11, 2014

Study Record Updates

Last Update Posted (Estimate)

March 24, 2015

Last Update Submitted That Met QC Criteria

March 19, 2015

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R03KD095740-02
  • R03DK095740 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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