A Mobile Phone-based Program for Adults With Prediabetes

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University of Michigan

Status

Completed

Conditions

Prediabetic State
Diabetes Mellitus

Treatments

Device: JOOL Health Mobile Phone Application

Study type

Interventional

Funder types

Other

Identifiers

NCT03025607
2420.PIRAP

Details and patient eligibility

About

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).

Full 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.

Enrollment

69 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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

Trial design

69 participants in 3 patient groups

Control
No Intervention group
Description:
Participants in this group will receive information on prediabetes and evidence-based ways to decrease progression to diabetes as well as a list of resources for mHealth tools for monitoring diet, physical activity, and weight.
JOOL-Only
Experimental group
Description:
Participants in this group will receive information on prediabetes and evidence-based ways to decrease progression to diabetes, a list of resources for mHealth tools to monitor diet, physical activity and weight, and will receive the JOOL Health mobile phone application.
Treatment:
Device: JOOL Health Mobile Phone Application
JOOL-Plus
Experimental group
Description:
Participants in this group will receive information on prediabetes and evidence-based ways to decrease progression to diabetes, a list of resources for mHealth tools to monitor diet, physical activity and weight, the JOOL Health mobile phone application, a digital scale, and a Fitbit.
Treatment:
Device: JOOL Health Mobile Phone Application

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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