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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): rationale and study protocol for a pragmatic randomised controlled trial

T. Vetrovsky, N. Kral, M. Pfeiferova, J. Kuhnova, J. Novak, C. Wahlich, A. Jaklova, K. Jurkova, M. Janek, D. Omcirk, V. Capek, I. Maes, M. Steffl, M. Ussher, JJ. Tufano, S. Elavsky, D. Van Dyck, R. Cimler, T. Yates, T. Harris, B. Seifert

. 2023 ; 23 (1) : 613. [pub] 20230331

Language English Country England, Great Britain

Document type Clinical Trial Protocol, Journal Article, Research Support, Non-U.S. Gov't

Persistent link   https://www.medvik.cz/link/bmc23010621

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).

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$a Kral, Norbert $u Institute of General Practice, 1st Faculty of Medicine, Charles University, Prague, Czech Republic
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$a Pfeiferova, Marketa $u Institute of General Practice, 1st Faculty of Medicine, Charles University, Prague, Czech Republic
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$a Kuhnova, Jitka $u Faculty of Science, University of Hradec Kralove, Hradec Kralove, Czech Republic
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$a Novak, Jan $u Faculty of Physical Education and Sport, Charles University, Prague, Czech Republic
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$a Wahlich, Charlotte $u Population Health Research Institute, St George's University of London, London, UK
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$a Capek, Vaclav $u 2nd Faculty of Medicine, Charles University, Prague, Czech Republic
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$a Maes, Iris $u Department of Movement and Sports Sciences, Ghent University, Ghent, Belgium
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$a Ussher, Michael $u Population Health Research Institute, St George's University of London, London, UK $u Institute for Social Marketing and Health, University of Stirling, Stirling, UK
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$a Tufano, James J $u Faculty of Physical Education and Sport, Charles University, Prague, Czech Republic
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$a Elavsky, Steriani $u Department of Human Movement Studies, University of Ostrava, Ostrava, Czech Republic
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$a Van Dyck, Delfien $u Department of Movement and Sports Sciences, Ghent University, Ghent, Belgium
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$a Cimler, Richard $u Faculty of Science, University of Hradec Kralove, Hradec Kralove, Czech Republic
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$a Harris, Tess $u Population Health Research Institute, St George's University of London, London, UK
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