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

NCT06621394 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-04-08

No results posted yet for this 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.

Conditions

  • Depressive Disorder, Major

Interventions

OTHER

nutritional intervention

nutritional intervention to mediterranean diet

BEHAVIORAL

Mindful Eating

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

OTHER

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

Sponsors & Collaborators

  • Robert Bosch Center for Integrative Medicine and Health

    collaborator UNKNOWN

  • Department of Psychosomatic Medicine, Robert Bosch Hospital Stuttgart

    collaborator UNKNOWN

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

    collaborator UNKNOWN

  • University Hospital Tuebingen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-05
Primary Completion
2025-03-01
Completion
2025-09-01

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06621394 on ClinicalTrials.gov