Clinical trial NCT01650337: mFit: The Mobile Fitness Project
Official title: Randomized Trial of a Smartphone Application for Weight Loss in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obese
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
First posted: 2012-07-26
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: weight loss
timeFrame: six months
Secondary outcomes:
measure: systolic blood pressure
timeFrame: six months
Other outcomes:
measure: Self-efficacy in dieting
timeFrame: six months
Locations:
city: Santa Monica
country: United States
facility: UCLA Family Health Center
state: California
city: Santa Monica
country: United States
facility: UCLA Internal Medicine
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Brian Y Laing, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.