Diabetes Mellitus Clinical Trial
Official title:
A Mixed Methods Pilot Randomized Controlled Trial of a Mobile Phone-based Health Program Among Adults With Prediabetes
Verified date | April 2018 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 69 |
Est. completion date | March 1, 2018 |
Est. primary completion date | March 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan | Blue Cross Blue Shield of Michigan Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Autonomous Motivation to Prevent T2DM | 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. | 12 Weeks | |
Secondary | Change in self-reported weight | Baseline to 12-week follow-up | ||
Secondary | Change in HbA1c | Baseline to 12-week follow-up | ||
Secondary | Change in psychosocial measures | Overall motivation to prevent T2DM; purpose in life; perceived competence to prevent T2DM; social support; eating behavior; self-reported physical activity; patient activation; willingness to participate in a Diabetes Prevention Program | Baseline to 12-week follow-up |
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