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.

Abstract

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). Feasibility multicentre, parallel group, randomised controlled trial (RCT). Participants were recruited from England and Canada using a decentralised design. Adults (40-75 years) recently diagnosed with T2D (5-24 months). 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. 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. 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). 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. ISRCTN: 14335124; ClinicalTrials.gov: NCT0465353.