NCT06990035Recruiting
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
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 29 Apr 2025
- Start date
- 26 Jan 2026
- Primary completion date
- Aug 2027
- Lead sponsor
- IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Diseases
- Depression
- NCT number
- NCT06990035
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 26 Jan 2026 to the primary completion date, Aug 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Orthopedic problems or other conditions limiting physical fitness assessment or currently pregnant.
- Active gastrointestinal diseases
- Autoimmune and/or chronic inflammatory disorders
Other
- Patients with severe psychopathology.
- Medical contraindications to physical activity.
- Patients who underwent antibiotic/anti-inflammatory treatments in the last 3 months
Who the study is looking for
- 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.
Age in the registry: 55 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Centro San Giovanni fi Dio Fatebenefratelli Coordinator of this site? Confirm its status | Brescia | Italy | Recruiting |
| Comunità Fraternità società cooperativa sociale ONLUS Coordinator of this site? Confirm its status | Ospitaletto | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.