Protocol for a Randomized Controlled Trial Comparing Diets for Diabetes Remission

A 12-month follow-up protocol describes a two-phase, multi-center randomized controlled trial enrolling 50 adults aged 18–65 years with type 2 diabetes in Northern Lebanon. The study compares a low-calorie Mediterranean-style diet to a low-calorie, low-carbohydrate diet, with primary and secondary outcomes including diabetes remission, weight changes, and metabolic markers. The protocol was authored by Janot J. Ayoub and published on figshare.

Use Cases

• Analyze the Intervention Mapping-based protocol structure for designing theory-driven behavioral interventions.
• Compare primary outcome definitions (HbA1c < 6.5%) and secondary outcome measures (weight, lipid profile, inflammatory markers) between the two dietary arms.
• Study the trial design elements, including the 6-month weight loss phase and 6-month maintenance phase supported by a mobile health application.
• Examine the participant inclusion criteria (age 18–65, diabetes duration ≤6 years, oral medication use) for sample selection methodology.

Strengths

• Protocol details a structured, two-phase randomized controlled trial design with a 12-month follow-up period.
• Specifies clear primary and secondary outcome measures, including HbA1c thresholds for diabetes remission.
• Describes a culturally relevant intervention tailored for a specific population in Northern Lebanon.

Limitations

• The dataset is a single document (43.1 KB) containing only the study protocol, not the resulting clinical trial data.
• Sample size is limited to 50 enrolled participants, which may restrict statistical power for some secondary outcomes.
• Geographic focus is exclusively on Northern Lebanon, limiting generalizability to other populations.

Provenance

Source

figshare

Collection Method

Designed as a clinical trial protocol using the Intervention Mapping framework.

Time Range

Protocol describes a trial with a 12-month follow-up period.

Freshness

Protocol last updated in April 2026.

Geography

Primary medical centers in Northern Lebanon.