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

Abstract

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).

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)

“…Given that self-monitoring using a simple activity tracker has been consistently demonstrated to be effective in increasing PA levels [ 45 , 49 ] and that providing PA advice by GPs is considered a standard of care [ 69 , 70 ], it was deemed unethical to withhold these components from control group participants. Therefore, in the ENERGISED randomised controlled trial [ 32 ], Fitbit and brief advice will also be provided to the control group participants. Additionally, this approach enables us to isolate the net effect of the mHealth intervention beyond the activity tracker effect [ 42 ].…”

“…To power the mHealth intervention, we have adapted the HealthReact system, developed at the University of Hradec Kralove [ 32 ] and compliant with rigorous data governance standards. HealthReact serves as a comprehensive platform to collect, integrate, and evaluate sensor data, particularly from devices like the Fitbit tracker.…”

“…We developed a pilot version of the mHealth intervention and tested it with patients who had prediabetes or uncomplicated type 2 diabetes, were not on insulin therapy, and were regular mobile phone users, meeting the ENERGISED trial eligibility criteria (detailed in Additional file 1). Recruitment was conducted by collaborating GPs as outlined in the ENERGISED trial protocol [ 32 ]. In brief, we compiled a list of all patients with (pre)diabetes from participating general practices’ computerised medical records.…”

“…As a practical response to these insights, the ENERGISED trial has been designed to evaluate the effectiveness of an innovative mHealth intervention in primary care for patients with (pre)diabetes, focusing on increasing PA and reducing sedentary behaviour. The rationale and study protocol for this trial has been described previously [ 32 ]. Briefly, this 12-month pragmatic, multicentre, randomised controlled trial aims to recruit 340 patients from 21 general practices, leveraging routine health check-ups for recruitment.…”

“…This paper aims to describe the participatory development and piloting of the mHealth intervention and its final version to be evaluated in the ENERGISED trial, complementing the previously published trial protocol [ 32 ]. Our decision to employ a participatory approach was driven by the recognition that the success of mHealth interventions, particularly in the context of physical activity and sedentary behaviour change, hinges on their relevance and adaptability to the end-users’ daily lives and challenges [ 33 , 34 ].…”