Final published version
Licence: CC BY: Creative Commons Attribution 4.0 International License
Research output: Contribution to Journal/Magazine › Journal article › peer-review
| Article number | e092260 |
|---|---|
| <mark>Journal publication date</mark> | 26/03/2025 |
| <mark>Journal</mark> | BMJ Open |
| Issue number | 3 |
| Volume | 15 |
| Publication Status | Published |
| <mark>Original language</mark> | English |
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.