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mFit: The Mobile Fitness Project (mFIT)

This study is not yet open for participant recruitment.
Verified August 2012 by University of California, Los Angeles
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: August 1, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention
Overweight
Obese
 Other: Smartphone Application

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Supportive Care
Official Title: Randomized Trial of a Smartphone Application for Weight Loss in Primary Care

Resource links provided by NLM:

MedlinePlus related topics: Weight Control
U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • weight loss [ Time Frame: six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • systolic blood pressure [ Time Frame: six months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Self-efficacy in dieting [ Time Frame: six months ] [ Designated as safety issue: No ]
    Based on 2 questions adapted from the diabetes empowerment scale (DES)


Estimated Enrollment: 180
Study Start Date: August 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01650337

Contacts
Contact: Brian Y Laing, MD 4242721953 blaing@mednet.ucla.edu
Contact: Cristina Punzalan, MPH

Locations
United States, California
UCLA Family Health Center Not yet recruiting
Santa Monica, California, United States, 90404
Contact: Michelle Bholat, MD            
UCLA Internal Medicine Not yet recruiting
Santa Monica, California, United States, 90404
Contact: Eve Glazier, MD            
Sponsors and Collaborators
University of California, Los Angeles
Robert Wood Johnson Foundation
Investigators
Principal Investigator: Brian Y Laing, MD University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Brian Y. Laing, Robert Wood Johnson Clinical Scholar, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01650337     History of Changes
Other Study ID Numbers: mFit-UCLA
Study First Received: July 23, 2012
Last Updated: August 1, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013