mFit: The Mobile Fitness Project (mFIT)

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.

Study Overview

• Status: Completed
• Conditions: Overweight; Obese
• Intervention / Treatment: Other: Smartphone Application

• Study Type: Interventional
• Enrollment (Actual): 212
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • UCLA Family Health Center
    • Santa Monica, California, United States, 90404
      • UCLA Internal Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
weight loss	six months

Secondary Outcome Measures

Outcome Measure	Time Frame
systolic blood pressure	six months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-efficacy in dieting	Based on 2 questions adapted from the diabetes empowerment scale (DES)	six months

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: Robert Wood Johnson Foundation
• Investigators: Principal Investigator: Brian Y Laing, MD, University of California, Los Angeles

Publications and helpful links

General Publications

• Laing BY, Mangione CM, Tseng CH, Leng M, Vaisberg E, Mahida M, Bholat M, Glazier E, Morisky DE, Bell DS. Effectiveness of a smartphone application for weight loss compared with usual care in overweight primary care patients: a randomized, controlled trial. Ann Intern Med. 2014 Nov 18;161(10 Suppl):S5-12. doi: 10.7326/M13-3005.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: July 23, 2012
• First Submitted That Met QC Criteria: July 25, 2012
• First Posted (Estimate): July 26, 2012

Study Record Updates

• Last Update Posted (Estimate): June 4, 2013
• Last Update Submitted That Met QC Criteria: June 2, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: mFit-UCLA