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

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Status: Not yet enrolling

Conditions: Major Depressive Disorder (MDD)

Treatments: Behavioral: Mediterranean diet lessons program; Behavioral: Physical activity

Study type: Interventional

Funder types: Other

Identifiers

NCT06990035

5M-2022-23685026

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 55 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

120 participants in 2 patient groups

Control Group

Active Comparator group

Description:

Mediterranean diet lessons program

Treatment:

Behavioral: Mediterranean diet lessons program

Experimental Group

Experimental group

Description:

Physical activity program

Treatment:

Behavioral: Mediterranean diet lessons program

Behavioral: Physical activity