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

Hesketh, K ORCID: 0000-0003-3409-3906, Low, J ORCID: 0000-0002-1964-6237, Andrews, R, Blitz, S, Buckley, B ORCID: 0000-0002-1479-8872, Falkenhain, K ORCID: 0000-0002-3240-964X, Job, J ORCID: 0000-0002-0307-9602, Jones, CA, Jones, H ORCID: 0000-0001-8282-1459, Jung, ME ORCID: 0000-0002-2360-0952, Little, J, Mateus, C ORCID: 0000-0001-6219-219X, Percival, SL, Pulsford, R, Russon, CL, Singer, J, Sprung, VS ORCID: 0000-0002-2666-4986, McManus, AM and Cocks, M ORCID: 0000-0003-1671-8714 (2025) 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. BMJ Open, 15 (3). ISSN 2044-6055

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Abstract

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.

Item Type:	Article
Uncontrolled Keywords:	Diabetes Mellitus, Type 2; Digital Technology; Exercise; Feasibility Studies; Telemedicine; eHealth; Humans; Diabetes Mellitus, Type 2; Middle Aged; Female; Male; Feasibility Studies; Exercise; Aged; Telemedicine; Canada; Adult; Patient Compliance; Motivation; United Kingdom; 1103 Clinical Sciences; 1117 Public Health and Health Services; 1199 Other Medical and Health Sciences; 32 Biomedical and clinical sciences; 42 Health sciences; 52 Psychology
Subjects:	R Medicine > RC Internal medicine > RC1200 Sports Medicine
Divisions:	Sport and Exercise Sciences
Publisher:	BMJ Publishing Group
Date of acceptance:	28 February 2025
Date of first compliant Open Access:	28 March 2025
Date Deposited:	28 Mar 2025 14:32
Last Modified:	03 Jul 2025 14:30
DOI or ID number:	10.1136/bmjopen-2024-092260
URI:	https://researchonline.ljmu.ac.uk/id/eprint/26032

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