RecruitingNot ApplicableNCT06621394

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

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


Sponsor

University Hospital Tuebingen

Enrollment

64 participants

Start Date

Nov 5, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether following a Mediterranean diet combined with mindful eating can improve depression in people who are both obese and depressed. Researchers are looking at whether these lifestyle changes can work alongside or even reduce the need for antidepressant medication. **You may be eligible if...** - You are 18 or older - You have been diagnosed with major depression and have at least moderate symptoms (BDI-II score of 20 or higher) - You have obesity (BMI of 30 or above) - Your antidepressant medication or therapy has not changed in the past 4 weeks - You currently eat a low-quality diet (low adherence to Mediterranean diet and mindful eating patterns) **You may NOT be eligible if...** - You have gut or digestive conditions that would prevent dietary changes (e.g., irritable bowel syndrome, post-bariatric surgery) - You have type 1 diabetes or chronic kidney disease - You have severe food allergies that prevent following the Mediterranean diet Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERnutritional intervention

nutritional intervention to mediterranean diet

BEHAVIORALMindful Eating

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

OTHERAttention 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


Locations(1)

Robert Bosch Center for Integrative Medicine and Health

Stuttgart, Germany

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NCT06621394


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