ENERGISED mHealth intervention in Czech republic general practice to increase physical activity of patients with prediabetes and type 2 diabetes: protocol and baseline findings from a pragmatic randomised controlled trial
Problem
The growing number of people living with prediabetes and type 2 diabetes is a major public health concern. Physical activity is crucial to diabetes prevention and management, but many people with (pre)diabetes remain physically inactive. Primary care is well-situated to deliver interventions to increase their patients' physical activity levels, but effective, sustainable physical activity interventions for (pre)diabetes patients that can be translated into routine primary care are lacking. This study aims to assess the effectiveness of an mHealth intervention delivered in general practice in the Czech Republic (ENERGISED) at increasing physical activity levels in patients with prediabetes or type 2 diabetes.
Approach
We describe the rationale and protocol for this 12-month pragmatic, multicentre randomised controlled trial. Twenty-eight general practices across the Czech Republic recruited 340 patients with (pre)diabetes during routine health check-ups. Active control arm participants receive a Fitbit activity tracker to self-monitor their daily steps. Intervention arm participants additionally receive the mHealth intervention, including delivery of several text messages weekly, with some delivered as “just in time adaptive intervention” tailored physical activity prompts, based on data continuously collected by the Fitbit tracker. The trial consists of two six-month phases: the lead-in phase, supported by phone counselling, and the maintenance phase, fully automated. The primary outcome, average ambulatory activity (steps/day) measured by a wrist-worn accelerometer, will be assessed at 12-month follow-up.
Findings
Trial recruitment has now been completed to target. Recruitment rate, baseline findings and initial findings from intervention implementation will be reported.
Consequences
The trial has several important strengths: 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 inclusion of patients without a smartphone; procedures to minimise selection bias; and involvement of a relatively large number of practices. These design choices contribute to the trial’s pragmatic character and ensure that the intervention, if shown to be effective, can be translated into routine primary care practice with the potential to increase physical activity levels in people living with prediabetes and type 2 diabetes.