A Mobile Phone-based Program for Adults With Prediabetes

NCT03025607 | Completed

• 1 other identifier: 2420.PIRAP
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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).

Conditions

Prediabetic State; Diabetes Mellitus

Keywords

Prevention; Mobile health; Autonomous motivation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in self-reported weight

  Baseline to 12-week follow-up

• Change in HbA1c

  Baseline to 12-week follow-up

• Change in psychosocial measures

  Baseline to 12-week follow-up

Study Arms (3)

Control

NO INTERVENTION

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

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.

Device: JOOL Health Mobile Phone Application

JOOL-Plus

EXPERIMENTAL

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.

Device: JOOL Health Mobile Phone Application

Interventions

JOOL Health Mobile Phone Application DEVICE

JOOL Health is a mobile phone-based application that aims to increase autonomous motivation to prevent T2DM by helping individuals make connections between certain health behaviors and the energy and willpower needed to achieve personal goals. On a daily basis, JOOL Health users chart the following health behaviors: Sleep, Presence, Activity, Creativity, and Eating. On a weekly basis, JOOL Health users are asked to record how well they lived according to their purpose and values. Through the integration of user-entered information with contextual data, JOOL Health provides tailored messaging and daily predictions of individuals' energy and willpower.

JOOL-Only; JOOL-Plus

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Blue Cross Blue Shield of Michigan Foundation: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (2)

• Griauzde D, Kullgren JT, Liestenfeltz B, Ansari T, Johnson EH, Fedewa A, Saslow LR, Richardson C, Heisler M. A Mobile Phone-Based Program to Promote Healthy Behaviors Among Adults With Prediabetes Who Declined Participation in Free Diabetes Prevention Programs: Mixed-Methods Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Jan 9;7(1):e11267. doi: 10.2196/11267.

  PMID: 30626566 DERIVED

• Griauzde DH, Kullgren JT, Liestenfeltz B, Richardson C, Heisler M. A mobile phone-based program to promote healthy behaviors among adults with prediabetes: study protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2018 Feb 13;4:48. doi: 10.1186/s40814-018-0246-z. eCollection 2018.

  PMID: 29449958 DERIVED

MeSH Terms

Conditions

Prediabetic State; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Dina Griauzde, MD

  Robert Wood Johnson Clinical Scholars Program (VA Scholar)

  STUDY DIRECTOR

• Michele Heisler, MD

  Robert Wood Johnson Clinical Scholars Program

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Michele Heisler, MD

Study Record Dates

• First Submitted: January 16, 2017
• First Posted: January 19, 2017
• Study Start: May 3, 2017
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: April 19, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)