NCT06621394

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-11-05
• Primary completion: 2025-03-01
• Completion: 2025-09-01
• First posted: 2024-10-01
• Last updated: 2025-04-08

Locations

1 site across 1 country: Germany