A mobile phone-based program to promote healthy behaviors among adults with prediabetes: study protocol for a pilot randomized controlled trial

Dina H Griauzde, Jeffrey T Kullgren, Brad Liestenfeltz, Caroline Richardson, Michele Heisler, Dina H Griauzde, Jeffrey T Kullgren, Brad Liestenfeltz, Caroline Richardson, Michele Heisler

Abstract

Background: Rates of participation in Diabetes Prevention Programs (DPPs) are low. This may be due, in part, to low levels of autonomous motivation (i.e., motivation that arises from internal sources and sustains healthy behaviors over time) to prevent type 2 diabetes (T2DM) among many individuals with prediabetes. Mobile health (mHealth) technologies that incorporate principles from the Self-Determination Theory offer an effective and scalable approach to increase autonomous motivation levels. One promising mobile phone-based application is JOOL Health, which aims to help users connect certain health behaviors (e.g., sleep and diet) with personal values in specific life domains (e.g., family and work). The first aim of this study is to estimate whether JOOL Health can increase autonomous motivation to prevent T2DM among individuals with prediabetes who declined DPP participation. The second aim of this pilot study is to examine the intervention's feasibility and acceptability.

Methods: This is a 12-week, three-arm pilot randomized controlled trial. We will recruit 105 individuals with prediabetes who did not engage in a DPP despite invitation from their health plan to participate in face-to-face or web-based programs at no out-of-pocket-cost. Participants will be randomized to one of three study arms: (1) a group that receives information on prediabetes, evidence-based strategies to decrease progression to T2DM, and a list of resources for mHealth tools for monitoring diet, physical activity, and weight (comparison group); (2) a group that receives the JOOL Health application; and (3) a group that receives the JOOL Health application as well as a Fitbit activity tracker and wireless-enabled scale. Our primary outcome is change in autonomous motivation to prevent T2DM (measured using the Treatment Self-Regulation Questionnaire). We will also collect data related to the intervention's feasibility (recruitment and retention rates) and acceptability (adherence and qualitative experience) as well as changes in psychosocial outcomes, hemoglobin A1c, and weight.

Discussion: To our knowledge, this is the first study that aims to promote positive health behaviors among individuals with prediabetes who previously declined to participate in a DPP. Our results will inform a larger trial to test the effect of JOOL Health on clinically relevant outcomes, including weight loss, physical activity, and DPP engagement.

Trial registration: NCT03025607. Registered February 2017.

Keywords: Autonomous motivation; Behavior change; Prediabetes; Prevention; Type 2 diabetes mellitus.

Conflict of interest statement

Dr. Griauzde is an Internal Medicine physician and a second year research fellow in the Robert Wood Johnson Foundation’s Clinical Scholars Program (VA Scholar).This study was approved by the Institutional Review Board at the University of Michigan.It is not applicable; individual participant’s data will not be included in any form.Drs. Griauzde, Heisler, and Richardson declare that they have no competing interests. Dr. Kullgren has received consulting fees from SeeChange Health and HealthMine, and a speaking honorarium from AbilTo, Inc.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study flow diagram

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