nutritional interventionMindful EatingAttention Control
nutritional intervention: nutritional intervention to mediterranean diet
Mindful Eating: intervention regarding mindful eating, e.g. attention while eating, apprechiation of food
Attention Control: Befreinding Control Group: Provision of same amout of time and attention, without having an intervention, e.g. talking about hobbies and interests, playing card games
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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)
* 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 (
inclusion criteria:
* age ≥ 18 years
* BMI 20 - 30 kg/m\^2
exclusion criteria:
* depression or other psychological comorbidities (bipolar disorder, eating disorder, personality disorder, psychosis)
* high adhernece to mediterranean diet: MEDAS ≥ 10
* high adherence to mindful eating: MEI ≥ 5.13
* 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
* pregnancy or breastfeeding
Primary outcome measure(s)
Depression severity — 12 weeks Beck Depression Inventory - II (BDI-II) scores range from 0 to 63 with higher scores indicating higher depression severity
Trial sites (1)
Facility
City
Region
Status
Robert Bosch Center for Integrative Medicine and Health
Stuttgart
Germany
Recruiting
More University Hospital Tuebingen trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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