Dietary Approaches to the Management Of type 2 Diabetes (DIAMOND): protocol for a randomised feasibility trial.

INTRODUCTION

Some clinicians have observed that low-carbohydrate, low-energy diets can improve blood glucose control, with reports of remission from type 2 diabetes in some patients. In clinical trials, support for low-carbohydrate, low-energy diets has been provided by specialist staff and these programmes are unsuitable for widespread deployment in routine primary care. The aim of this trial is to test whether a newly developed behavioural support programme can effectively deliver a low-energy, low-carbohydrate diet in a primary care setting.

METHODS AND ANALYSIS

This is a feasibility randomised controlled trial (RCT) with embedded qualitative study. Thirty adult patients with type 2 diabetes and body mass index ≥30 kg/m in 2-4 general practices will be randomised 2:1 intervention or control and followed up over 12 weeks. The intervention diet comprises 8 weeks of a low-carbohydrate food-based diet providing around 800 kcal/day, followed by 4 weeks of weight maintenance. This programme will be delivered by practice nurses, who will also support patients through goal-setting, motivation and self-monitoring across four appointments, and provide a self-help booklet with recipes, shopping lists and other behavioural support. Primary outcome measures of feasibility will be met if CIs do not cross the following proportions: that 60% of intervention group participants attempt the dietary intervention, healthcare professionals conduct the intervention delivery session with at least 60% of essential elements present and 60% of participants attend the final follow-up session. Secondary outcome measures will assess process and qualitative measures, as well as exploratory outcomes including change in haemoglobin A1c and change in weight.

ETHICS AND DISSEMINATION

This study has been granted ethical approval by the National Research Ethics Service, South Central Oxford B Research Ethics Committee (ref: 18/SC/0071). The study results will inform whether to progress to a full-scale RCT to test the efficacy of offering this programme for patients with type 2 diabetes in primary care.

TRIAL REGISTRATION NUMBER

ISRCTN62452621; Pre-results.