Diet and Mindful Eating Tested for Depression in People With Obesity
Tests a Mediterranean diet and mindful eating in adults with obesity and major depression.
Plain-language title generated from the registry record
Registry title: The Effect of Mediterranean Diet and Mindfulness Eating on Depression Severity in People With Obesity and Major Depressive Disorder
Key facts
- Where
- Stuttgart, GermanySee the site
Where in Germany
- Robert Bosch Center for Integrative Medicine and HealthStuttgart, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital Tuebingen
- Trial code
- NCT06621394
- Record updated
- 8 April 2025
- Original description
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.Read full original descriptionShow less
The Effect of Mediterranean Diet and Mindfulness Eating on Depression Severity in People With Obesity and Major Depressive Disorder - a Randomized Controlled Study With Mulitfactorial Design
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.
Inclusion: Age ≥ 18 years; Presence of clinically diagnosed major depression; At least moderate depression severity: BDI-II ≥ 20; obesity: BMI ≥ 30 kg/m2; Stable co-intervention: no change in the type, dosage or frequency of antidepressant medication and/or psychotherapy four weeks before and during the study; Low adherence to the mediterranean diet: MEDAS < 10; Low adherence to mindful eating: MEI < 5.13; age ≥ 18 years; BMI 20 - 30 kg/m\^2.
Exclusion: Diseases of the gastrointestinal tract that do not allow adequate implementation of the intervention (e.g. irritable bowel syndrome, post-bariatric surgery, colorectal carcinoma); Metabolic diseases with strong impact on intervention (e.g. type 1 diabetes mellitus, chronic kidney disease); Severe food allergies and intolerances, that do not allow adequate implementation of the intervention; Diagnosed, current psychological comorbidities (bipolar disorder, eating disorder, personality disorder, psychosis); depression or other psychological comorbidities (bipolar disorder, eating disorder, personality disorder, psychosis); Diseases of the gastrointestinal tract or metabilic diseases (e.g. irritable bowel syndrome, post-bariatric surgery, colorectal carcinoma, type 1 diabetes mellitus); -- intake of antibiotics in the last three months current substance abuse; intake of antibiotics in the last three months current substance abuse; Pregnancy and breatfeeding; Suicidal ideation; unable to participate or complete questionnaires; Healthy Volunteers:; samples of 32 healthy volunteers are included for microbiome analysis only (; high adhernece to mediterranean diet: MEDAS ≥ 10; high adherence to mindful eating: MEI ≥ 5.13; pregnancy or breastfeeding.