Protocol compares Mediterranean and low-carb diets for diabetes remission in Lebanese adults

Type 2 diabetes mellitus (T2DM) is increasing worldwide, largely due to obesity and unhealthy lifestyle behaviors. Weight-loss–induced diabetes remission offers a promising approach to reducing complications and improving quality of life. Addressing this effectively requires a comprehensive approach that targets behavioral and environmental determinants and is guided by the Intervention Mapping (IM) protocol. This paper describes the protocol for a randomized controlled trial comparing two low-calorie dietary approaches for achieving diabetes remission in adults with T2DM, using an IM-based intervention framework. This is a two-phase, multi-center, parallel-group randomized controlled trial conducted in primary medical centers in Northern Lebanon. A total of 50 adults aged 18–65 years, with a maximum diabetes duration of 6 years and treated with oral antidiabetic medications, are enrolled. Participants are randomly assigned to follow either a low-calorie Mediterranean-style diet or a low-calorie, low-carbohydrate diet. The study consists of a 6-month weight loss phase developed using the six steps of the (IM) protocol, followed by a 6-month maintenance phase supported by a mobile health application, resulting in a total follow-up duration of 12 months. The primary outcome is diabetes remission at 6 months (HbA1c  Sustained weight loss is essential for achieving diabetes remission and reducing metabolic complications; however, long-term success depends on realistic and maintainable behavioral changes. This protocol applies the IM framework to systematically develop a culturally relevant, theory-based intervention tailored to individuals with T2DM in Lebanon. By combining dietary strategies with behavioral support and mobile health technology, the study addresses barriers to long-term adherence. The findings are expected to inform the design of scalable, context-specific interventions for diabetes management in similar low- and middle-income settings. https://www.isrctn.com/ISRCTN99204002, Identifier ISRCTN99204002.