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Trial record 1 of 1 for:    NCT02160834
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Reducing Sedentary Time in Obese Adults (Study 2) (B-MOBILE)

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ClinicalTrials.gov Identifier: NCT02160834
Recruitment Status : Withdrawn (study not initiated)
First Posted : June 11, 2014
Last Update Posted : March 24, 2015
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
The Miriam Hospital

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) Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : January 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Change in percentage of daily sedentary time from baseline to post-intervention. [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Change in percentage of daily sedentary time from baseline to follow-up [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02160834


Locations
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United States, Rhode Island
The Weight Control and Diabetes Research Center
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
The Miriam Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Dale S Bond, PhD The Miriam Hospital/Brown Alpert Medical School

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Responsible Party: The Miriam Hospital
ClinicalTrials.gov Identifier: NCT02160834     History of Changes
Other Study ID Numbers: 1R03KD095740-02
R03DK095740 ( U.S. NIH Grant/Contract )
First Posted: June 11, 2014    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: June 2014
Keywords provided by The Miriam Hospital:
Sedentary behavior
Physical activity
Obesity
Mobile health
Smartphone
Time spent sedentary
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms