Overweight Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Supportive Care
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