A Mixed Methods Pilot Randomized Controlled Trial of a Mobile Phone-based Health Program Among Adults With Prediabetes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prediabetic State
- Sponsor
- University of Michigan
- Enrollment
- 69
- Locations
- 1
- Primary Endpoint
- Change in Autonomous Motivation to Prevent T2DM
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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).
Detailed Description
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.
Investigators
Mary Ellen Michele Heisler
Dr. Michele Heisler, MD
University of Michigan
Eligibility Criteria
Inclusion Criteria
- •Invited to participate in a DPP by the participant's health plan, but have not engaged in a program at least 6 months after receiving the first letter of invitation
- •Wireless internet access
- •Personal smartphone access
Exclusion Criteria
- •Individuals currently participating in another lifestyle or behavior change program or research study
- •Inability to read, write, or speak English
- •Inability to provide informed consent
- •Women who are pregnant or intend to become pregnant during the intervention period
Outcomes
Primary Outcomes
Change in Autonomous Motivation to Prevent T2DM
Time Frame: 12 Weeks
Change from baseline mean score on a scale of 1 - 7 as assessed by the Treatment Self Regulation Questionnaire- Autonomous Section survey instrument where 1 means little autonomous motivation and 7 means high autonomous motivation.
Secondary Outcomes
- Change in psychosocial measures(Baseline to 12-week follow-up)
- Change in self-reported weight(Baseline to 12-week follow-up)
- Change in HbA1c(Baseline to 12-week follow-up)