Manchester Intermittent versus Daily Diet App Study (MIDDAS): A pilot randomized controlled trial in patients with...

Area of Science:

• Endocrinology and Metabolism
• Nutritional Science
• Digital Health Interventions

Background:

• Type 2 diabetes (T2D) management often requires significant lifestyle changes, including weight loss.
• Remotely delivered dietary interventions offer a scalable approach to support individuals with T2D.
• Low-energy diets (LEDs), both intermittent (ILED) and continuous (CLED), are established methods for weight reduction.

Purpose of the Study:

• To assess the feasibility and potential efficacy of remotely supported ILED and CLED programs in adults with T2D.
• To evaluate the feasibility of conducting a randomized controlled trial comparing ILED and CLED approaches.
• To examine weight loss and glycated hemoglobin (HbA1c) changes at 52 weeks.

Main Methods:

• Seventy-nine adults with overweight/obesity and T2D were randomized to either an 8-week CLED or a 28-week ILED (2 days/week).
• Both groups received remote support via telephone or the Oviva app throughout the 52-week study.
• Feasibility outcomes included study uptake, retention, app usage, dietary adherence, weight loss, and HbA1c changes.

Main Results:

• High participant retention (69-75%) and app engagement (86% usage at 52 weeks) were observed.
• Both ILED and CLED groups achieved significant mean weight loss (-5.4% and -6.0%, respectively) at 52 weeks.
• Forty-two percent of participants in both groups reached an HbA1c below 48 mmol/mol; CLED showed a significant reduction in T2D medication score.

Conclusions:

• Remotely delivered ILED and CLED programs are feasible and demonstrate potential efficacy for weight loss and HbA1c reduction in T2D.
• The study successfully demonstrated the feasibility of a randomized controlled trial comparing these two dietary approaches.
• Digital health support integrated with low-energy diets offers a viable strategy for managing type 2 diabetes remotely.