NCT06990035

Implementation of a Multiple Intervention to Promote Healthy Lifestyles in Patients With Depression

Implementazione di un Intervento Multiplo Per Promuovere Stili di Vita Sani in Pazienti Con Depressione: Uno Studio Clinico Controllato e Randomizzato

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: IRCCS Centro San Giovanni di Dio Fatebenefratelli · Academic / Other
• Sex: All
• Age: 55 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial aims to investigate whether an integrative approach combining education on the Mediterranean diet and physical activity (PA) can significantly reduce depressive symptomatology in individuals with major depressive disorder. The study will evaluate changes in depressive symptoms and assess biological modulations, including alterations in the gut microbiota and inflammatory markers, resulting from the PA intervention. Participants will be randomized into two arms: the active control group will attend a series of lessons focused on the Mediterranean diet, while the experimental group will participate in the same dietary lessons combined with a structured PA program of 12 weeks.

Conditions

• Major Depressive Disorder (MDD)

Interventions

Type	Name	Description
BEHAVIORAL	Mediterranean diet lessons program	Participants will attend five one-hour lessons delivered by qualified professionals to learn about foods that have a positive impact on cognitive function and how to incorporate them into their dietary regimen.
BEHAVIORAL	Physical activity	Participants will undergo a 12-week physical exercise program guided by specified personal trainers.

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2025-05-25
• Last updated: 2025-05-25

Locations

1 site across 1 country: Italy