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

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated May 25, 2025 (before its estimated February 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT06990035
Lead Sponsor IRCCS Centro San Giovanni di Dio Fatebenefratelli
Conditions
(from sponsor)		 Major Depressive Disorder (MDD)
Related terms Major Depressive Disorder, Motor Activity
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov