Motivation and Problem Solving Versus Mobile 360° Videos to Promote Enrollment in the National Diabetes Prevention Program's Lifestyle Change Program Among People With Prediabetes: Protocol for a Randomized Trial.

BACKGROUND

More than 88 million Americans are at risk of developing type 2 diabetes mellitus (T2DM). The National Diabetes Prevention Program's Lifestyle Change Program (DPP LCP) has been shown to be effective in reducing the risk of progressing from prediabetes to T2DM. However, most individuals who could benefit from the program do not enroll.

OBJECTIVE

The aim of this trial is to test the real-world efficacy of 3 mobile phone-based approaches to increasing enrollment in the DPP LCP including a best-practice condition and 2 novel approaches.

METHODS

We will conduct a 3-armed randomized clinical trial comparing enrollment and 1-month engagement in the DPP LCP among adults with prediabetes from 2 health care settings. Participants in the best-practice condition will receive SMS-based notifications that they have prediabetes and a link to a website that explains prediabetes, T2DM, and the DPP LCP. This will be followed by a single question survey, "Would you like the DPP LCP to call you to enroll?" Participants in the 2 intervention arms will receive the same best-practice intervention plus either 2 mobile 360° videos or up to 5 brief phone calls from a health coach trained in a motivational coaching approach known as Motivation and Problem Solving (MAPS). We will collect measures of diabetes-related knowledge, beliefs in the controllability of risk for T2DM, risk perceptions for T2DM, and self-efficacy for lifestyle change pre-intervention and 4 weeks later. The primary outcomes of the study are enrollment in the DPP LCP and 4-week engagement in the DPP LCP. In addition, data on the person-hours needed to deliver the interventions as well as participant feedback about the interventions and their acceptability will be collected. Our primary hypotheses are that the 2 novel interventions will lead to higher enrollment and engagement in the DPP LCP than the best-practice intervention. Secondary hypotheses concern the mechanisms of action of the 2 intervention arms: (1) whether changes in risk perception are associated with program enrollment among participants in the mobile 360° video group and (2) whether changes in self-efficacy for lifestyle change are associated with program enrollment among participants in the MAPS coaching group. Finally, exploratory analyses will examine the cost effectiveness and acceptability of the interventions.

RESULTS

The project was funded in September 2020; enrollment began in February 2021 and is expected to continue through July 2022.

CONCLUSIONS

We are conducting a test of 2 novel, scalable, mobile phone-based interventions to increase enrollment in the DPP LCP. If effective, they have tremendous potential to be scaled up to help prevent T2DM nationwide.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04746781; https://clinicaltrials.gov/ct2/show/NCT04746781.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/28884.