A randomized controlled trial protocol comparing low-calorie Mediterranean and low-carbohydrate diets for diabetes remission in individuals with type 2 diabetes in northern Lebanon: an intervention mapping-based approach
Abstract
Background: 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.
Objective: 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.
Methods: 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 < 6.5% with or without discontinuation of medication). Secondary outcomes include sustained remission at 12 months, changes in weight…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 50 participants or records.
Read the paper
Related studies
- eggNOG 5.0: a hierarchical, functionally and phylogenetically annotated orthology resource based on 5090 organisms and 2502 viruses
- Online Survival Analysis Software to Assess the Prognostic Value of Biomarkers Using Transcriptomic Data in Non-Small-Cell Lung Cancer
- OptiType: precision HLA typing from next-generation sequencing data
- Nicotinic Cholinergic System and COVID-19: In Silico Identification of an Interaction between SARS-CoV-2 and Nicotinic Receptors with Potential Therapeutic Targeting Implications
- Saccharomyces cerevisiae cells have three Omega class glutathione S-transferases acting as 1-Cys thiol transferases
- Hemolysis at low blood flow rates: in-vitro and in-silico evaluation of a centrifugal blood pump
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.