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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-31

Study Completion Date

2026-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Major Depressive Disorder (MDD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control Group

Mediterranean diet lessons program

Group Type ACTIVE_COMPARATOR

Mediterranean diet lessons program

Intervention Type BEHAVIORAL

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.

Experimental Group

Physical activity program

Group Type EXPERIMENTAL

Mediterranean diet lessons program

Intervention Type BEHAVIORAL

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.

Physical activity

Intervention Type BEHAVIORAL

Participants will undergo a 12-week physical exercise program guided by specified personal trainers.

Interventions

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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.

Intervention Type BEHAVIORAL

Physical activity

Participants will undergo a 12-week physical exercise program guided by specified personal trainers.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Primary diagnosis of depression (DSM-5 criteria, American Psychiatric Association 2013).
* Depressive symptoms assessed using MADR, BDI, or ZDR scales.
* Ability to provide written informed consent.
* Self-reported moderate-intensity leisure physical activity of less than 150 minutes per week.

Exclusion Criteria

* Patients with severe psychopathology.
* Medical contraindications to physical activity.
* Orthopedic problems or other conditions limiting physical fitness assessment or currently pregnant.
* Patients who underwent antibiotic/anti-inflammatory treatments in the last 3 months
* Active gastrointestinal diseases
* Autoimmune and/or chronic inflammatory disorders

Minimum Eligible Age

55 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No