BACKGROUND: The growing number of patients with type 2 diabetes and prediabetes is a major public health concern. Physical activity is a cornerstone of diabetes management and may prevent its onset in prediabetes patients. Despite this, many patients with (pre)diabetes remain physically inactive. Primary care physicians are well-situated to deliver interventions to increase their patients' physical activity levels. However, effective and sustainable physical activity interventions for (pre)diabetes patients that can be translated into routine primary care are lacking. METHODS: We describe the rationale and protocol for a 12-month pragmatic, multicentre, randomised, controlled trial assessing the effectiveness of an mHealth intervention delivered in general practice to increase physical activity and reduce sedentary behaviour of patients with prediabetes and type 2 diabetes (ENERGISED). Twenty-one general practices will recruit 340 patients with (pre)diabetes during routine health check-ups. Patients allocated to the active control arm will receive a Fitbit activity tracker to self-monitor their daily steps and try to achieve the recommended step goal. Patients allocated to the intervention arm will additionally receive the mHealth intervention, including the delivery of several text messages per week, with some of them delivered just in time, based on data continuously collected by the Fitbit tracker. The trial consists of two phases, each lasting six months: the lead-in phase, when the mHealth intervention will be supported with human phone counselling, and the maintenance phase, when the intervention will be fully automated. The primary outcome, average ambulatory activity (steps/day) measured by a wrist-worn accelerometer, will be assessed at the end of the maintenance phase at 12 months. DISCUSSION: The trial has several strengths, such as the choice of active control to isolate the net effect of the intervention beyond simple self-monitoring with an activity tracker, broad eligibility criteria allowing for the inclusion of patients without a smartphone, procedures to minimise selection bias, and involvement of a relatively large number of general practices. These design choices contribute to the trial's pragmatic character and ensure that the intervention, if effective, can be translated into routine primary care practice, allowing important public health benefits. TRIAL REGISTRATION: ClinicalTrials.gov (NCT05351359, 28/04/2022).

2nd Faculty of Medicine Charles University Prague Czech Republic

Department of Human Movement Studies University of Ostrava Ostrava Czech Republic

Department of Movement and Sports Sciences Ghent University Ghent Belgium

Diabetes Research Centre University of Leicester Leicester UK

Faculty of Physical Education and Sport Charles University Prague Czech Republic

Faculty of Science University of Hradec Kralove Hradec Kralove Czech Republic

Institute for Social Marketing and Health University of Stirling Stirling UK

Institute of General Practice 1st Faculty of Medicine Charles University Prague Czech Republic

National Institute for Health Research Leicester Biomedical Research Centre University Hospitals of Leicester NHS Trust and the University of Leicester Leicester UK

Population Health Research Institute St George's University of London London UK

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mHealth intervention delivered in general practice to increase physical activity and reduce sedentary behaviour of patients with prediabetes and type 2 diabetes (ENERGISED): statistical analysis plan

Sensor-triggered ecological momentary assessment in physical activity and sedentary behaviour research among Belgian community-dwelling elderly: lessons learnt from intensive longitudinal studies

Contexts, affective and physical states and their variations during physical activity in older adults: an intensive longitudinal study with sensor-triggered event-based ecological momentary assessments

Fitbit's accuracy to measure short bouts of stepping and sedentary behaviour: validation, sensitivity and specificity study

Participatory development of an mHealth intervention delivered in general practice to increase physical activity and reduce sedentary behaviour of patients with prediabetes and type 2 diabetes (ENERGISED)

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