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mFit: The Mobile Fitness Project (mFIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01650337
Recruitment Status : Completed
First Posted : July 26, 2012
Last Update Posted : June 4, 2013
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
Brian Y. Laing, University of California, Los Angeles

Brief Summary:

BACKGROUND: The nascent field of mobile health (mHealth) is expanding with impressive speed. In March 2012, experts estimated that 40,000 health related smartphone applications were on the market but little is known about the effectiveness of these programs. To our knowledge, no studies have evaluated whether weight loss can be successfully achieved through use of a smartphone application or how these applications could be used in primary care practice.

PURPOSE: To evaluate the effectiveness of a popular, free smartphone application for weight loss and calorie counting in a primary care setting.

METHODS: The first phase of this study involved a community based participatory approach to select the intervention. Patient focus groups were conducted and analyzed to explore patients' preferences regarding various text-message versus smartphone programs. The second phase of this study, described here, will be a randomized controlled trial with overweight primary care patients exposed to one of two conditions for 6 months: (1) usual care; (2) usual care plus smartphone application, which includes instructing participants on how to use the application and encouraging them to use the applications' reminders and social networking features. The primary outcome of interest is weight change at 3 and 6 months. Two-sample t-test or Wilcoxon rank sum test will be used to compare weight change between groups, as appropriate. ANCOVA models will be used to examine weight change after adjusting for covariates such as education, sex and age. Repeated measures analysis will be carried out to compare weight change between the groups using baseline, 3 month and 6 month data. In addition to an intent-to-treat analysis, the investigators will also conduct a "treatment received" analysis, adjusting for the extent of application use in both the intervention and control arms.

CONCLUSIONS: This study will demonstrate whether a smartphone application introduced in primary care settings and incorporated into the visit can produce weight loss. Study findings could inform a national discourse on the value of smartphone applications in routine clinical practice.

Condition or disease Intervention/treatment Phase
Overweight Obese Other: Smartphone Application Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Supportive Care
Official Title: Randomized Trial of a Smartphone Application for Weight Loss in Primary Care
Study Start Date : August 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Smartphone Application
Patients will be given access to a smartphone application for weight loss and instructed on how to use it.
Other: Smartphone Application
Smartphone application to help monitor caloric intake and expenditure

No Intervention: Usual primary care

Primary Outcome Measures :
  1. weight loss [ Time Frame: six months ]

Secondary Outcome Measures :
  1. systolic blood pressure [ Time Frame: six months ]

Other Outcome Measures:
  1. Self-efficacy in dieting [ Time Frame: six months ]
    Based on 2 questions adapted from the diabetes empowerment scale (DES)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • primary care patient at UCLA Family Health Center or 16th Street Internal Medicine
  • age 18 or older,
  • English speaking,
  • BMI > 25,
  • interested in losing weight,
  • smartphone ownership,
  • valid email address.

Exclusion Criteria:

  • current, planned or previous pregnancy within 6 months,
  • currently using a smartphone app for dieting,
  • hemodialysis,
  • 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 identifier (NCT number): NCT01650337

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United States, California
UCLA Family Health Center
Santa Monica, California, United States, 90404
UCLA Internal Medicine
Santa Monica, California, United States, 90404
Sponsors and Collaborators
University of California, Los Angeles
Robert Wood Johnson Foundation
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Principal Investigator: Brian Y Laing, MD University of California, Los Angeles
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Brian Y. Laing, Robert Wood Johnson Clinical Scholar, University of California, Los Angeles Identifier: NCT01650337    
Other Study ID Numbers: mFit-UCLA
First Posted: July 26, 2012    Key Record Dates
Last Update Posted: June 4, 2013
Last Verified: June 2013
Additional relevant MeSH terms:
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Body Weight