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mFit: The Mobile Fitness Project (mFIT)

Primary Purpose

Overweight, Obese

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Smartphone Application
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Overweight

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UCLA Family Health Center
  • UCLA Internal Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Smartphone Application

Usual primary care

Arm Description

Patients will be given access to a smartphone application for weight loss and instructed on how to use it.

Outcomes

Primary Outcome Measures

weight loss

Secondary Outcome Measures

systolic blood pressure

Full Information

First Posted
July 23, 2012
Last Updated
June 2, 2013
Sponsor
University of California, Los Angeles
Collaborators
Robert Wood Johnson Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01650337
Brief Title
mFit: The Mobile Fitness Project
Acronym
mFIT
Official Title
Randomized Trial of a Smartphone Application for Weight Loss in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
Robert Wood Johnson Foundation

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obese

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
212 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Smartphone Application
Arm Type
Experimental
Arm Description
Patients will be given access to a smartphone application for weight loss and instructed on how to use it.
Arm Title
Usual primary care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Smartphone Application
Intervention Description
Smartphone application to help monitor caloric intake and expenditure
Primary Outcome Measure Information:
Title
weight loss
Time Frame
six months
Secondary Outcome Measure Information:
Title
systolic blood pressure
Time Frame
six months
Other Pre-specified Outcome Measures:
Title
Self-efficacy in dieting
Description
Based on 2 questions adapted from the diabetes empowerment scale (DES)
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Y Laing, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Family Health Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
UCLA Internal Medicine
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25402403
Citation
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.
Results Reference
derived

Learn more about this trial

mFit: The Mobile Fitness Project

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