mFit: The Mobile Fitness Project

Overweight Clinical Trial

— mFIT  

Official title:

Randomized Trial of a Smartphone Application for Weight Loss in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01650337
• Other study ID #: mFit-UCLA
• Status: Completed
• Phase: N/A
• First received: July 23, 2012
• Last updated: June 2, 2013
• Start date: August 2012
• Est. completion date: May 2013

Study information

• Verified date: June 2013
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Obese
• Overweight

Intervention

Other:
• Smartphone Application
Smartphone application to help monitor caloric intake and expenditure

Locations

Country	Name	City	State
United States	UCLA Family Health Center	Santa Monica	California
United States	UCLA Internal Medicine	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-efficacy in dieting	Based on 2 questions adapted from the diabetes empowerment scale (DES)	six months	No
Primary	weight loss		six months	No
Secondary	systolic blood pressure		six months	No