Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 3:44 AM
Study NCT ID:
NCT06621394
Status:
RECRUITING
Last Update Posted:
2025-04-08
First Post:
2024-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Mediterranean Diet and Mindfulness Eating on Depression Severity in People With Obesity and Major Depressive Disorder
Sponsor:
University Hospital Tuebingen
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MEDIMIND
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: