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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Depressive Disorder, Major
• Intervention / Treatment: Other: nutritional intervention; Behavioral: Mindful Eating; Other: Attention Control

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 Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alina Moosburner, MSc; Phone Number: +4971181013764; Email: alina.moosburner@med.uni-tuebingen.de
• Study Contact Backup: Name: Holger Cramer, Prof. Dr.; Email: holger.cramer@med.uni-tuebingen.de

Study Locations

• Germany
  • Stuttgart, Germany, 70376
    • Recruiting
    • Robert Bosch Center for Integrative Medicine and Health
    • Contact: Alina Moosburner; Phone Number: 071181013764; Email: alina.moosburner@med.uni-tuebingen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Diseases of the gastrointestinal tract that do not allow adequate implementation of the intervention (e.g. irritable bowel syndrome, post-bariatric surgery, colorectal carcinoma)
• Metabolic diseases with strong impact on intervention (e.g. type 1 diabetes mellitus, chronic kidney disease)
• Severe food allergies and intolerances, that do not allow adequate implementation of the intervention
• Diagnosed, current psychological comorbidities (bipolar disorder, eating disorder, personality disorder, psychosis)
• intake of antibiotics in the last three months current substance abuse
• Pregnancy and breatfeeding
• Suicidal ideation
• unable to participate or complete questionnaires

Healthy Volunteers:

samples of 32 healthy volunteers are included for microbiome analysis only (

inclusion criteria:

• age ≥ 18 years
• BMI 20 - 30 kg/m^2

exclusion criteria:

• depression or other psychological comorbidities (bipolar disorder, eating disorder, personality disorder, psychosis)
• high adhernece to mediterranean diet: MEDAS ≥ 10
• high adherence to mindful eating: MEI ≥ 5.13

• Diseases of the gastrointestinal tract or metabilic diseases (e.g. irritable bowel syndrome, post-bariatric surgery, colorectal carcinoma, type 1 diabetes mellitus)

  -- intake of antibiotics in the last three months current substance abuse

• pregnancy or breastfeeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mediterranean Diet	Other: nutritional intervention; nutritional intervention to mediterranean diet
Experimental: Mindful Eating	Behavioral: Mindful Eating; intervention regarding mindful eating, e.g. attention while eating, apprechiation of food
Experimental: Mediterranean Diet and Mindful Eating	Other: nutritional intervention; nutritional intervention to mediterranean diet; Behavioral: Mindful Eating; intervention regarding mindful eating, e.g. attention while eating, apprechiation of food
Sham Comparator: Befriending	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression severity	Beck Depression Inventory - II (BDI-II) scores range from 0 to 63 with higher scores indicating higher depression severity	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression Remission Rates	rates of participants showing no depressive symptoms, defined as BDI-II less than 9	12 weeks, 24 weeks
Quality of Life	Short Form-36 Health Survey (SF-36), mental and physical sum score, which can be further divided into the subscales vitality, physical functioning, physical pain, general health perception, physical role function, emotional role function, social role function and psychological well-being, higher scores indicate a higher quality of life	12 weeks, 24 weeks
Self-efficacy	general self-efficacy expectation scale, score ranges from 10 to 40, with a higher score indicating a greater expectation of self-efficacy	12 weeks, 24 weeks
Health status	European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L), results in a 5-digit number that describes the patient's health state	12 weeks,
Adhernece to Mediterranean Diet	mediterranean diet adherence score (MEDAS) scores range from 0 to 14 with higher values indicating higher adherence to mediterranean diet	12 weeks, 24 weeks
Adherence to Mindfulnes Eating	Mindfulness Eating Inventory (MEI), score ranges from 1 to 6, with higher scores indicating higher adherence to mindfulness eating	12 weeks, 24 weeks
BMI	weight and height will be combined to report BMI in kg/m^2	12 weeks, 24 weeks
Waist to Hip ratio	ratio of weight circumference and hip circumference	12 weeks, 24 weeks
Body composition: muscle mass	muscle mass as a percentage of body weight	12 weeks, 24 weeks
Body composition: fat mass	fat mass as a percentage of body weight	12 weeks, 24 weeks
adverse events	time point, duration (in hours or days) and strengths (on a scale from one to ten) of andverse events will be assessed as well as perception of connection between occurrence of adverse event and the intervention	12 weeks, 24 weeks
Microbiome Analysis	16s RNA sequencing	12 weeks
cost-utility analysis	from EQ-5D-5L values quality adjustes life years (QUALYS) will be calulated to conduct cost-utility analysis from participants perspective	12 weeks
Qualitative evaluation	Semi-structured interviews will consider two areas: the perception on the intervention in terms of feasibility, difficulties in implementation, perception of study setting, planning of long-term implementation, etc.; perception of effects of interventions, qualitative evaluation of changes in outcoms, i.e. mood, psychological and physical well-being, self-efficacy, etc	12 weeks
Depression severity, self assessment	Beck Depression Inventory - II (BDI-II) scores range from 0 to 63 with higher scores indicating higher depression severity	24 weeks
Depression severity, rater assesment	Depresion severity is assessed by psychologists by using the MARDS tool. Scores range from 0 to 60 with higher scores idnicating higher severity of depression	12 weeks

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Collaborators: Robert Bosch Center for Integrative Medicine and Health; Department of Psychosomatic Medicine, Robert Bosch Hospital Stuttgart; Microbial Genetics, Interfaculty Institute of Microbiology and Infection Medicine Tübingen, University of Tübingen

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2024
• Primary Completion (Actual): March 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: September 23, 2024
• First Submitted That Met QC Criteria: September 27, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: depression; obesity; nutrition; mediterranean diet; mindfulnes eating
• Additional Relevant MeSH Terms: Mental Disorders; Nutrition Disorders; Overnutrition; Body Weight; Behavioral Symptoms; Mood Disorders; Overweight; Obesity; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: medimind

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No