Reducing Sedentary Time in Obese Adults

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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Behavioral intervention
Behavioral intervention to reduce sedentary time delivered via mobile smartphone
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Average daily sedentary minutes
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Average daily adherence to prompts to reduce sedentary time delivered via mobile smartphone
Time Frame: 4 weeks
4 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, Ph.D., The Miriam Hospital/Brown Alpert Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

February 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

September 17, 2012

First Submitted That Met QC Criteria

September 19, 2012

First Posted (Estimate)

September 20, 2012

Study Record Updates

Last Update Posted (Estimate)

March 24, 2015

Last Update Submitted That Met QC Criteria

March 19, 2015

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1R03DK095740-01 (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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