Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence in Type 2 Diabetes (MOTIVATE-T2D) : a decentralised feasibility randomised controlled trial delivered across the UK and Canada

OBJECTIVES: Assess the feasibility of a mobile health (mHealth)-supported home-delivered physical activity (PA) intervention (MOTIVATE-T2D) in people with recently diagnosed type 2 diabetes (T2D). DESIGN: Feasibility multicentre, parallel group, randomised controlled trial (RCT). SETTING: Participants were recruited from England and Canada using a decentralised design. PARTICIPANTS: Adults (40-75 years) recently diagnosed with T2D (5-24 months). INTERVENTIONS: Participants were randomised 1:1 to intervention (MOTIVATE-T2D) or active control groups. Participants codesigned 6month- home-delivered, personalised, progressive PA programmes supported by virtual behavioural counselling. MOTIVATE-T2D used biofeedback from wearable technologies to support the programme. The active control group received the same intervention without wearables. OUTCOMES: The primary outcomes were recruitment rate, retention and adherence to purposeful exercise. Clinical data on effectiveness were collected as exploratory outcomes at baseline, 6 and 12 months, with HbA1c and systolic blood pressure (BP) proposed as primary outcomes for a future full RCT. RESULTS: n=135 eligible participants expressed an interest in the trial, resulting in 125 participants randomised (age 55±9 years, 48% female, 81% white), a recruitment rate of 93%. Retention at 12 months was 82%. MOTIVATE-T2D participants were more likely to start (OR 10.4, CI 3.4 to 32.1) and maintain purposeful exercise at 6 (OR 7.1, CI 3.2 to 15.7) and 12 months (OR 2.9, CI 1.2 to 7.4). Exploratory clinical outcomes showed a potential effect in favour of MOTIVATE-T2D, including proposed primary outcomes HbA1c and systolic BP (between-group mean differences: HbA1c: 6 months: -5% change from baseline, CI -10 to 2: 12 months: -2% change from baseline, CI -8 to -4; systolic BP: 6 months: -1 mm Hg, CI -5 to 3: 12 months: -4 mm Hg, CI -8 to 1). CONCLUSIONS: Our findings support the feasibility of delivering the MOTIVATE-T2D mHealth-supported PA intervention for people with recently diagnosed T2D and progression to a full RCT to examine its clinical and cost-effectiveness. TRIAL REGISTRATION NUMBER: ISRCTN: 14335124; ClinicalTrials.gov: NCT0465353.