Diabetes Mellitus Clinical Trial
Official title:
A Mixed Methods Pilot Randomized Controlled Trial of a Mobile Phone-based Health Program Among Adults With Prediabetes
Type 2 diabetes mellitus (T2DM) can be prevented through weight loss and increased physical
activity, yet its prevalence continues to rise. This trend may be due in part to low rates of
participation in evidence-based lifestyle change programs such as the Diabetes Prevention
Program (DPP). New strategies are needed to promote healthy behaviors among individuals at
risk for T2DM, and mobile health technologies may be an effective and scalable approach to
achieve this. One promising tool is JOOL Health, a mobile phone-based application that
leverages principles from Self-Determination Theory to help individuals understand how
certain behaviors (e.g. sleep, diet, physical activity) influence their ability to pursue
their core values and purpose in life. Through personalized messaging and feedback, JOOL
Health aims to increase autonomous motivation, a form of motivation closely associated with
the initiation and maintenance of healthy behaviors.
In this mixed methods pilot randomized controlled trial, the investigators will test whether
the JOOL Health mobile phone-based application -- used alone and in conjunction with other
mobile health technologies to track weight and physical activity -- can increase autonomous
motivation to prevent type 2 diabetes mellitus (T2DM) among individuals with prediabetes who
previously declined participation in a Diabetes Prevention Program (DPP).
This 12-week pilot randomized controlled trial aims to recruit 156 individuals with
prediabetes who declined participation in a formal DPP despite invitation to participate at
no out-of-pocket cost by their health plan. Participants will be randomized to 1 of 3 study
arms: (1) a group that receives information on prediabetes, evidence-based strategies to
decrease progression to diabetes, and a list of resources for mHealth tools for monitoring
diet, physical activity, and weight (control group); (2) a group that receives the JOOL
Health mobile phone application; and (3) a group that receives the JOOL Health mobile phone
application and other mHealth tools (e.g. Fitbit activity tracker and wireless-enabled scale)
whose results can be uploaded into JOOL.
The investigators will use a mixed methods approach with a sequential explanatory design,
which is to say that quantitative data and qualitative data will be collected in 2
consecutive phases within the study. Specifically, in the first phase, investigators will
collect and analyze qualitative data (e.g. focus groups) from a purposive sample of
participants with differing levels of engagement and success. The rationale for this approach
is that the quantitative data will provide a general overview of the intervention's efficacy
and limitations, and the qualitative data will help to explain these findings by exploring
participants' experiences and perspectives in more depth.
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