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

In this paper, we describe the protocol of a randomised controlled trial assessing the effectiveness of the mHealth intervention delivered in general practice to increase PA and reduce sedentary behaviour of patients with prediabetes and type 2 diabetes (ENERGISED). The mHealth intervention includes the delivery of several text messages per week, with some of them delivered just in time, based on the data continuously collected by sensors embedded in a Fitbit activity tracker worn by patients. The intervention is introduced to the patients by their GPs during a routine health check-up and is initially supported by monthly phone counselling sessions delivered by trained counsellors. The trial has been designed as a pragmatic trial to ensure that the intervention, if shown to be effective, can be translated into routine practice in primary care settings.