Rationale and design of a parallel randomised trial of a plant‐based intensive lifestyle intervention for diabetes remission: The REmission of diabetes using a PlAnt‐based weight loss InteRvention (REPAIR) trial

Abstract Aims As type 2 diabetes (T2D) continues to rise globally and remains a major driver of cardiovascular disease, its remission has emerged as a therapeutic target. Current evidence supports bariatric surgery and low‐calorie diets with meal replacements. No clinical trial to date has evaluated plant‐based dietary alternatives as an intensive lifestyle intervention (ILI) strategy, despite the emphasis on plant‐based diets in current clinical practice guidelines for diabetes and cardiovascular disease. The REmission of diabetes using a PlAnt‐based weight loss InteRvention (REPAIR) trial will assess whether a 52‐week plant‐based ILI targeting ≥15% weight loss is effective for diabetes remission in a multi‐ethnic Canadian population. Materials and Methods The REPAIR trial is a prospective, randomised, 2‐arm, open‐label, blinded‐endpoint efficacy trial. Participants will include 160 adults with early T2D (<6 years) and living with obesity. They will be randomised to standard of care or a 2‐phase ILI targeting ≥15% weight loss consisting of a 12‐week weight loss phase on a plant‐based total diet meal replacement, followed by a 40‐week weight loss maintenance phase on a plant‐based dietary pattern combined with a 16‐week structured exercise program, and a 52‐week (19‐session) sustainable behaviour change curriculum. The primary outcome is diabetes remission (HbA1c <6.5% without glucose‐lowering medication for ≥3 months) and the key secondary outcome is the proportion achieving ≥15% weight loss at 52 weeks. Conclusions This trial will provide high‐quality clinical evidence on the use of plant‐based ILIs to address the epidemics of obesity and diabetes to inform public health policies and programs in Canada and beyond.