mFIT: mFit: The Mobile Fitness Project

Sponsor
University of California, Los Angeles (Other)
Overall Status
Completed
CT.gov ID
NCT01650337
Collaborator
Robert Wood Johnson Foundation (Other)
212
2
2
9
106
11.8

Study Details

Study Description

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
  • Other: Smartphone Application
N/A

Study Design

Study Type:
Interventional
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 :
Aug 1, 2012
Actual Primary Completion Date :
May 1, 2013
Actual Study Completion Date :
May 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. weight loss [six months]

Secondary Outcome Measures

  1. systolic blood pressure [six months]

Other Outcome Measures

  1. Self-efficacy in dieting [six months]

    Based on 2 questions adapted from the diabetes empowerment scale (DES)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UCLA Family Health Center Santa Monica California United States 90404
2 UCLA Internal Medicine Santa Monica California United States 90404

Sponsors and Collaborators

  • University of California, Los Angeles
  • Robert Wood Johnson Foundation

Investigators

  • Principal Investigator: Brian Y Laing, MD, University of California, Los Angeles

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Brian Y. Laing, Robert Wood Johnson Clinical Scholar, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01650337
Other Study ID Numbers:
  • mFit-UCLA
First Posted:
Jul 26, 2012
Last Update Posted:
Jun 4, 2013
Last Verified:
Jun 1, 2013
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 4, 2013