Mobile Phone App to Promote Lifestyle Change in People at Risk of Type 2 Diabetes: Feasibility 3-Arm Randomized Controlled Trial.

Background: The use of mobile health interventions, such as 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 the Plunde app for promoting and monitoring individual goals related to lifestyle change for people at risk of T2D. Objective: The primary aim of this study was to assess the feasibility of an app for promoting lifestyle change in people at risk of T2D. The secondary aim was to assess recruitment rate, resource requirements, and change in potential outcomes for a full scale randomized controlled trial (RCT) study . Methods: A 3-arm feasibility RCT lasting 12 weeks was designed. Participants were recruited from 9 general practitioners in Norway. Eligible participants were randomized to either (1) app follow-up; (2) app follow-up and referral to care as usual in Healthy Life Centers; or (3) referral to care as usual in a Healthy Life Center, only. The primary outcome was feasibility and was measured by app adherence (actual usage of the app), the System Usability Scale, and app motivation score gained from a questionnaire designed for this study. Criteria for success were preset based on these measures. Secondary outcomes included recruitment rate, resource requirements, and potential primary outcomes of a full-scale RCT. This included change in body weight, waist circumference, and self-evaluated functional health status, assessed with the Dartmouth Primary Care Cooperative Research Network/World Organization of Family Doctors (COOP/WONCA) functional health assessment chart. Results: Within 8 months, 9 general practitioners recruited a total of 54 participants, of which 45 were eligble for participation in the study. Mean age was 61 (SD 13) years and 53% (n=24) were female. App adherence was 86%, the mean System Usability Scale score was 87.3 (SD 11.9), and the mean app motivation score was 74.8 (SD 30.3). Throughout the intervention period, health care professionals spent on average 3.0 (SD 1.0) minutes per participant per week providing follow-up. Statistically significant reduction in body weight and waist circumference was shown in group 1 and 3. Conclusions: Based on the preset criteria for success, the Plunde app is feasible in providing support for lifestyle change. The Plunde app had excellent user satisfaction. The amount of time spent on monitoring and promoting lifestyle change through the app was low; however, the recruitment was slow. Results from this study will guide the development of further research within this field.