mFit: The Mobile Fitness Project (mFIT)

This study has been completed.
Sponsor:
Collaborator:
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
Brian Y. Laing, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01650337
First received: July 23, 2012
Last updated: June 2, 2013
Last verified: June 2013

July 23, 2012
June 2, 2013
August 2012
May 2013   (final data collection date for primary outcome measure)
weight loss [ Time Frame: six months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01650337 on ClinicalTrials.gov Archive Site
systolic blood pressure [ Time Frame: six months ] [ Designated as safety issue: No ]
Same as current
Self-efficacy in dieting [ Time Frame: six months ] [ Designated as safety issue: No ]
Based on 2 questions adapted from the diabetes empowerment scale (DES)
Same as current
 
mFit: The Mobile Fitness Project
Randomized Trial of a Smartphone Application for Weight Loss in Primary Care

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Supportive Care
  • Overweight
  • Obese
Other: Smartphone Application
Smartphone application to help monitor caloric intake and expenditure
  • Experimental: Smartphone Application
    Patients will be given access to a smartphone application for weight loss and instructed on how to use it.
    Intervention: Other: Smartphone Application
  • No Intervention: Usual primary care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
212
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01650337
mFit-UCLA
Yes
Brian Y. Laing, University of California, Los Angeles
University of California, Los Angeles
Robert Wood Johnson Foundation
Principal Investigator: Brian Y Laing, MD University of California, Los Angeles
University of California, Los Angeles
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP