A mobile phone app to promote lifestyle change in people at risk of type 2 diabetes: A feasibility three-armed randomized controlled trial (Preprint)

BACKGROUND The use of mobile health (mHealth) interventions, such as applications (apps) are proposed to meet the challenges faced by preventive health care services due to the increasing prevalence of type 2 diabetes (T2D). Thus, we developed and conducted initial feasibility testing of a mobile phone app for promoting and monitoring individual goals related to lifestyle change for people at risk of T2D. OBJECTIVE The aim of this study is to assess the feasibility of an app for promoting lifestyle change in people at risk of T2D. METHODS A three-armed randomized-controlled feasibility study with participants referred from nine general practitioners (GPs) in Norway. Eligible participants were randomized to eighter: (1) app follow-up; (2) app follow-up and care as usual in Healthy Life Centers (HLCs); (3) care as usual in HLC. Feasibility was evaluated with log data on system use, the System Usability Scale (SUS) and a questionnaire designed for this study. Criteria for success were preset and were based on these feasibility outcomes. In addition, recruitment rate and resource requirements were assessed. Potential primary outcomes in a full scale RCT were evaluated to get experience with the measurements and to examine a potential change. This included waist circumference, bodyweight and self-evaluated functional health status. RESULTS From May 2023 to Dec 2023, 45 participants were included. Mean age was 61(±13) years and 52.3 % were female. The completion rate was 91%. The mean SUS score was 86.9 (±12.1), and the mean app motivation score was 74.6 (±32.7). Within eight months, nine GPs recruited a total of 54 participants, of which 45 were eligible to participate in the study. Health care professionals spent on average 3.0 (±1.0) minutes per participant per week providing follow-up. A statistically significant improvement was observed for all participants from baseline to follow-up in waist circumference, bodyweight and self-evaluated functional health status. CONCLUSIONS It is feasible to use the app to provide lifestyle change in people at risk of T2D. The app had excellent user satisfaction. The amount of time spent on monitoring and promoting lifestyle change through the app, was low, however, recruitment was slow. Results from this study will guide the development of further research within this field. CLINICALTRIAL The feasibility study is registered in Clinical Trials, ID: NCT06117098