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

Status: Recruiting
Location: See location...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Germany
Robert Bosch Center for Integrative Medicine and Health
RECRUITING
Stuttgart
Contact Information
Primary
Alina Moosburner, MSc
alina.moosburner@med.uni-tuebingen.de
+4971181013764
Backup
Holger Cramer, Prof. Dr.
holger.cramer@med.uni-tuebingen.de
Time Frame
Start Date: 2024-11-05
Estimated Completion Date: 2025-09-01
Participants
Target number of participants: 64
Treatments
Experimental: Mediterranean Diet
Experimental: Mindful Eating
Experimental: Mediterranean Diet and Mindful Eating
Sham_comparator: Befriending
Related Therapeutic Areas
Sponsors
Leads: University Hospital Tuebingen
Collaborators: Department of Psychosomatic Medicine, Robert Bosch Hospital Stuttgart, Robert Bosch Center for Integrative Medicine and Health, Microbial Genetics, Interfaculty Institute of Microbiology and Infection Medicine Tübingen, University of Tübingen

This content was sourced from clinicaltrials.gov