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

Abstract

BackgroundRates 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.MethodsThis 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.DiscussionTo 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 registrationNCT03025607. Registered February 2017.Electronic supplementary materialThe online version of this article (10.1186/s40814-018-0246-z) contains supplementary material, which is available to authorized users.

Mixed methods pilot study of a low-carbohydrate diabetes prevention programme among adults with pre-diabetes in the USA

“…Twelve per cent (n=22) of eligible individuals enrolled in our study within 2 weeks of receiving an invitation letter. LC-DPP participation was slightly higher than that observed in traditional DPPs,6–8 including those offered by our institution’s self-funded health plan 40. Given room-size limitations and the pilot nature of this study, we ceased recruitment efforts once we met our enrolment target, and we may therefore be underestimating potential LC-DPP participation.…”

Association Between Life Purpose and Mortality Among US Adults Older Than 50 Years

“…There are also eHealth applications designed to influence life purpose (eg, Purposeful). 39,40 Future research should focus on the mechanism of how life purpose may influence all-cause mortality and cause-specific mortality and on the appropriate timing of life purpose interventions in a diseased population. Ultimately, a randomized trial exploring life purpose interventions and disease outcomes, quality of life, and mortality are warranted.…”

Preventing Type 2 Diabetes Among Midlife Women: A Feasibility Study Comparing a Combined Sleep and Lifestyle Intervention With a Standard Lifestyle Intervention

“…Some programs acknowledged that sleep interventions might enhance energy balance interventions but included only minimal educational materials and few if any measures of sleep duration or quality. 21,22 In a pilot randomized controlled trial, a fully integrated sleep, diet, and activity lifestyle intervention compared with lifestyle alone led to more rapid weight loss. 23 This pilot study evaluated treatment effects immediately after the 3-month program, with no additional follow-up.…”