Fukushima study for Engaging people with type 2 Diabetes in Behaviour Associated Change (FEEDBACK): study protocol for a cluster randomised controlled trial

<jats:title>Abstract</jats:title><jats:sec> <jats:title>Background</jats:title> <jats:p>The growing burden of type 2 diabetes mellitus (T2DM) and the rising cost of healthcare worldwide make it imperative to identify interventions that can promote sustained self-management behaviour in T2DM populations while minimising costs for healthcare systems. The present FEEDBACK study (Fukushima study for Engaging people with type 2 Diabetes in Behaviour Associated Change) aims to evaluate the effects of a novel behaviour change intervention designed to be easily implemented and scaled across a wide range of primary care settings.</jats:p> </jats:sec><jats:sec> <jats:title>Methods</jats:title> <jats:p>A cluster randomised controlled trial (RCT) with a 6-month follow-up will be conducted to evaluate the effects of the FEEDBACK intervention. FEEDBACK is a personalised, multi-component intervention intended to be delivered by general practitioners during a routine diabetes consultation. It consists of five steps aimed at enhancing doctor-patient partnership to motivate self-management behaviour: (1) communication of cardiovascular risks using a ‘heart age’ tool, (2) goal setting, (3) action planning, (4) behavioural contracting, and (5) feedback on behaviour. We aim to recruit 264 adults with T2DM and suboptimal glycaemic control from 20 primary care practices in Japan (cluster units) that will be randomly assigned to either the intervention or control group. The primary outcome measure will be the change in HbA1c levels at 6-month follow-up. Secondary outcome measures include the change in cardiovascular risk score, the probability to achieve the recommended glycaemic target (HbA1c <7.0% [53mmol/mol]) at 6-month follow-up, and a range of behavioural and psychosocial variables. The planned primary analyses will be carried out at the individual level, according to the intention-to-treat principle. Between-group comparisons for the primary outcome will be analysed using mixed-effects models. This study protocol received ethical approval from the research ethics committee of Kashima Hospital, Fukushima, Japan (reference number: 2022002).</jats:p> </jats:sec><jats:sec> <jats:title>Discussion</jats:title> <jats:p>This article describes the design of a cluster RCT that will evaluate the effects of FEEDBACK, a personalised, multicomponent intervention aimed at enhancing doctor-patient partnership to engage adults with T2DM more effectively in self-management behaviour.</jats:p> </jats:sec><jats:sec> <jats:title>Trial registration</jats:title> <jats:p>The study protocol was prospectively registered in the UMIN Clinical Trials Registry (UMIN-CTR ID UMIN000049643 assigned on 29/11/2022). On submission of this manuscript, recruitment of participants is ongoing.</jats:p> </jats:sec>