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A Mobile Phone-based Program for Adults With Prediabetes

Primary Purpose

Prediabetic State, Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
JOOL Health Mobile Phone Application
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prediabetic State focused on measuring Prevention, Mobile health, Autonomous motivation

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

JOOL-Only

JOOL-Plus

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in self-reported weight
Change in HbA1c
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

Full Information

First Posted
January 16, 2017
Last Updated
April 18, 2018
Sponsor
University of Michigan
Collaborators
Blue Cross Blue Shield of Michigan Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03025607
Brief Title
A Mobile Phone-based Program for Adults With Prediabetes
Official Title
A Mixed Methods Pilot Randomized Controlled Trial of a Mobile Phone-based Health Program Among Adults With Prediabetes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
May 3, 2017 (Actual)
Primary Completion Date
March 1, 2018 (Actual)
Study Completion Date
March 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Blue Cross Blue Shield of Michigan Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetic State, Diabetes Mellitus
Keywords
Prevention, Mobile health, Autonomous motivation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm 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.
Arm Title
JOOL-Only
Arm Type
Experimental
Arm 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.
Arm Title
JOOL-Plus
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
JOOL Health Mobile Phone Application
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Autonomous Motivation to Prevent T2DM
Description
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.
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Change in self-reported weight
Time Frame
Baseline to 12-week follow-up
Title
Change in HbA1c
Time Frame
Baseline to 12-week follow-up
Title
Change in psychosocial measures
Description
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
Time Frame
Baseline to 12-week follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dina Griauzde, MD
Organizational Affiliation
Robert Wood Johnson Clinical Scholars Program (VA Scholar)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Michele Heisler, MD
Organizational Affiliation
Robert Wood Johnson Clinical Scholars Program
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30626566
Citation
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.
Results Reference
derived
PubMed Identifier
29449958
Citation
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.
Results Reference
derived

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A Mobile Phone-based Program for Adults With Prediabetes

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