Actively Recruiting
The Effect of Mediterranean Diet and Mindfulness Eating on Depression Severity in People With Obesity and Major Depressive Disorder
Led by University Hospital Tuebingen · Updated on 2025-04-08
64
Participants Needed
1
Research Sites
42 weeks
Total Duration
On this page
Sponsors
U
University Hospital Tuebingen
Lead Sponsor
R
Robert Bosch Center for Integrative Medicine and Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
The present study investigates the effect of Mediterranean Diet and Mindful Eating on depression severity in people with obesity and major depressive disorder. The factorial design allows to investigate potential synergistic effects of the interventions. Participants will be randomized to one of the four intervention groups (mediterranean diet, mindful eating, their combination and a befriending control group). The intervention consists of a 12-week period, followed by a 12-week follow up. The primary outcome is depression severity.
CONDITIONS
Official Title
The Effect of Mediterranean Diet and Mindfulness Eating on Depression Severity in People With Obesity and Major Depressive Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Clinically diagnosed major depression
- Moderate or higher depression severity with a BDI-II score of 20 or more
- Obesity with a BMI of 30 kg/m2 or higher
- Stable antidepressant medication or psychotherapy for at least 4 weeks before and during the study
- Low adherence to the Mediterranean diet (MEDAS score less than 10)
- Low adherence to mindful eating (MEI score less than 5.13)
You will not qualify if you...
- Gastrointestinal diseases that prevent following the intervention (e.g., irritable bowel syndrome, post-bariatric surgery, colorectal cancer)
- Metabolic diseases that strongly affect the intervention (e.g., type 1 diabetes, chronic kidney disease)
- Severe food allergies or intolerances preventing intervention
- Current psychological disorders like bipolar disorder, eating disorders, personality disorders, or psychosis
- Antibiotic use in the last 3 months or current substance abuse
- Pregnancy or breastfeeding
- Suicidal thoughts
- Inability to participate or complete questionnaires
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Robert Bosch Center for Integrative Medicine and Health
Stuttgart, Germany, 70376
Actively Recruiting
Research Team
A
Alina Moosburner, MSc
CONTACT
H
Holger Cramer, Prof. Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here