Randomized Controlled Trial Protocol for Diabetes Remission in Lebanon

One protocol details a 12-month trial comparing low-calorie Mediterranean and low-carbohydrate diets for 50 adults with type 2 diabetes in Northern Lebanon. Janot J. Ayoub authored this study protocol, which was last updated in April 2026. The document outlines the intervention mapping methodology, primary and secondary outcomes, and trial registration.

Use Cases

• Analyze the Intervention Mapping framework steps used to design the culturally tailored behavioral intervention.
• Compare primary outcome definitions (HbA1c < 6.5%) and secondary outcome measures (weight, lipid profile, inflammatory markers) between the two diet arms.
• Review the trial's inclusion criteria (age 18-65, diabetes duration ≤6 years) and exclusion logic for participant selection.
• Examine the mobile health application's role in the 6-month maintenance phase for adherence support.
• Study the protocol's data collection schedule for outcomes assessed at baseline and every 3 months over 12 months.

Strengths

• Protocol is registered with ISRCTN (Identifier ISRCTN99204002), providing transparency and traceability.
• Clearly defines primary (diabetes remission at 6 months) and multiple secondary outcomes including physiological and psychological markers.
• Employs a structured Intervention Mapping methodology across six steps for developing the behavioral intervention.

Limitations

• The dataset is a single 75 KB document describing a protocol, not the actual trial results or participant data.
• Sample size is limited to 50 participants, which may restrict the statistical power for some secondary outcome analyses.
• Geographic scope is restricted to primary medical centers in Northern Lebanon, limiting generalizability.

Provenance

Source

figshare, authored by Janot J. Ayoub.

Collection Method

Designed as a research protocol for a two-phase, multi-center, parallel-group randomized controlled trial.

Time Range

Trial follow-up duration is 12 months per the protocol.

Freshness

Protocol document was last updated on 2026-04-08.

Geography

Primary medical centers in Northern Lebanon.