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Completed

NCT Number: NCT01650337

mFit: The Mobile Fitness Project

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA Family Health Center, Santa Monica, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smartphone Application

Other

Smartphone application to help monitor caloric intake and expenditure

Primary outcomes

  1. weight loss

    Time frame: six months

Secondary outcomes

  1. systolic blood pressure

    Time frame: six months

Other outcomes

  1. Self-efficacy in dieting

    Time frame: six months

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

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Robert Wood Johnson Foundation

Registry information

Official study title

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

Acronym: mFIT

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 26, 2012
Registry last updated
Jun 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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