The Effect of Mediterranean Diet and Mindfulness Eating on Depression Severity in People With Obesity and Major Depressive Disorder

NCT ID: NCT06621394

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-05
• Study Completion Date: 2025-09-01

Brief 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.

Detailed Description

Depression and obesity are highly prevalent diseases that are strongly correlated. There is a growing gap in care and treatment options for those affected. The effectiveness of a Mediterranean Diet on mental health has already been shown in various studies. Additionally to physiological effects of nutrient intake, also the psychological factor of changing the way of eating seem to play a role. The present study investigates the effect of a Mediterranean Diet and Mindful Eating on depression severity in people with obesity and clinically diagnosed 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, where five individual nutrition consueling meetings will take place, followed by a 12-week follow up. The primary outcome is depression severity. Secondary outcomes and analyzes include quality of life, self-efficacy, mediterranean diet and mindfulness eating scores, anthropometric measurements, as well as mediator and moderator analysis, a microbiome analysis, a qualitative evaluation and an economic analysis.

Conditions

Depressive Disorder, Major

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mediterranean Diet

Group Type: EXPERIMENTAL

nutritional intervention

Intervention Type: OTHER

nutritional intervention to mediterranean diet

Mindful Eating

Group Type: EXPERIMENTAL

Mindful Eating

Intervention Type: BEHAVIORAL

intervention regarding mindful eating, e.g. attention while eating, apprechiation of food

Mediterranean Diet and Mindful Eating

Group Type: EXPERIMENTAL

nutritional intervention

Intervention Type: OTHER

nutritional intervention to mediterranean diet

Mindful Eating

Intervention Type: BEHAVIORAL

intervention regarding mindful eating, e.g. attention while eating, apprechiation of food

Befriending

Group Type: SHAM_COMPARATOR

Attention Control

Intervention Type: OTHER

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

Interventions

nutritional intervention

nutritional intervention to mediterranean diet

Intervention Type: OTHER

Mindful Eating

intervention regarding mindful eating, e.g. attention while eating, apprechiation of food

Intervention Type: BEHAVIORAL

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

Intervention Type: OTHER

Eligibility Criteria

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

• age ≥ 18 years
• BMI 20 - 30 kg/m^2

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 (

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Robert Bosch Center for Integrative Medicine and Health

UNKNOWN

Sponsor Role: collaborator

Department of Psychosomatic Medicine, Robert Bosch Hospital Stuttgart

UNKNOWN

Sponsor Role: collaborator

Microbial Genetics, Interfaculty Institute of Microbiology and Infection Medicine Tübingen, University of Tübingen

UNKNOWN

Sponsor Role: collaborator

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Robert Bosch Center for Integrative Medicine and Health

Stuttgart, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Alina Moosburner, MSc

Role: CONTACT

alina.moosburner@med.uni-tuebingen.de

+4971181013764

Holger Cramer, Prof. Dr.

Role: CONTACT

holger.cramer@med.uni-tuebingen.de

Facility Contacts

Alina Moosburner

Role: primary

alina.moosburner@med.uni-tuebingen.de

071181013764

Other Identifiers

medimind

Identifier Type: -

Identifier Source: org_study_id