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

NCT06621394 | Recruiting

• 1 other identifier: medimind
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder, Major

Keywords

depression; mediterranean diet; mindfulnes eating; nutrition; obesity

Outcome Measures

Primary Outcomes (1)

• Depression severity

  Beck Depression Inventory - II (BDI-II) scores range from 0 to 63 with higher scores indicating higher depression severity

  12 weeks

Secondary Outcomes (16)

• Depression severity, self assessment

  24 weeks

• Depression Remission Rates

  12 weeks, 24 weeks

• Quality of Life

  12 weeks, 24 weeks

• Self-efficacy

  12 weeks, 24 weeks

• Health status

  12 weeks,

Study Arms (4)

Mediterranean Diet

EXPERIMENTAL

Other: nutritional intervention

Mindful Eating

EXPERIMENTAL

Behavioral: Mindful Eating

Mediterranean Diet and Mindful Eating

EXPERIMENTAL

Other: nutritional intervention; Behavioral: Mindful Eating

Befriending

SHAM COMPARATOR

Other: Attention Control

Interventions

nutritional intervention OTHER

nutritional intervention to mediterranean diet

Mediterranean Diet; Mediterranean Diet and Mindful Eating

Mindful Eating BEHAVIORAL

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

Mediterranean Diet and Mindful Eating; Mindful Eating

Attention Control 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

Befriending

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 (
• age ≥ 18 years
• BMI 20 - 30 kg/m\^2
• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• Robert Bosch Center for Integrative Medicine and Health: collaborator
• Department of Psychosomatic Medicine, Robert Bosch Hospital Stuttgart: collaborator
• Microbial Genetics, Interfaculty Institute of Microbiology and Infection Medicine Tübingen, University of Tübingen: collaborator

Study Sites (1)

Robert Bosch Center for Integrative Medicine and Health

Stuttgart, 70376, Germany

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Depression; Obesity

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Alina Moosburner, MSc

CONTACT

+4971181013764; alina.moosburner@med.uni-tuebingen.de

Holger Cramer, Prof. Dr.

CONTACT

holger.cramer@med.uni-tuebingen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: data analysis will be conducted blinded
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2x2 factorial design

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: October 1, 2024
• Study Start: November 5, 2024
• Primary Completion: March 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 8, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)