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NCT Number: NCT06621394

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Robert Bosch Center for Integrative Medicine and Health

Stuttgart, 70376, Germany

Location status: Recruiting

Location contact

Alina Moosburner

CONTACT

[email protected]

071181013764

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutritional intervention

Other

nutritional intervention to mediterranean diet

Mindful Eating

Behavioral

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

Attention Control

Other

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

Primary outcomes

  1. Depression severity

    Time frame: 12 weeks

    Beck Depression Inventory - II (BDI-II) scores range from 0 to 63 with higher scores indicating higher depression severity

Secondary outcomes

  1. Depression severity, self assessment

    Time frame: 24 weeks

    Beck Depression Inventory - II (BDI-II) scores range from 0 to 63 with higher scores indicating higher depression severity

  2. Depression Remission Rates

    Time frame: 12 weeks, 24 weeks

    rates of participants showing no depressive symptoms, defined as BDI-II less than 9

  3. Quality of Life

    Time frame: 12 weeks, 24 weeks

    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

  4. Self-efficacy

    Time frame: 12 weeks, 24 weeks

    general self-efficacy expectation scale, score ranges from 10 to 40, with a higher score indicating a greater expectation of self-efficacy

  5. Health status

    Time frame: 12 weeks,

    European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L), results in a 5-digit number that describes the patient's health state

  6. Adhernece to Mediterranean Diet

    Time frame: 12 weeks, 24 weeks

    mediterranean diet adherence score (MEDAS) scores range from 0 to 14 with higher values indicating higher adherence to mediterranean diet

  7. Adherence to Mindfulnes Eating

    Time frame: 12 weeks, 24 weeks

    Mindfulness Eating Inventory (MEI), score ranges from 1 to 6, with higher scores indicating higher adherence to mindfulness eating

  8. Depression severity, rater assesment

    Time frame: 12 weeks

    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

  9. BMI

    Time frame: 12 weeks, 24 weeks

    weight and height will be combined to report BMI in kg/m^2

  10. Waist to Hip ratio

    Time frame: 12 weeks, 24 weeks

    ratio of weight circumference and hip circumference

  11. Body composition: muscle mass

    Time frame: 12 weeks, 24 weeks

    muscle mass as a percentage of body weight

  12. Body composition: fat mass

    Time frame: 12 weeks, 24 weeks

    fat mass as a percentage of body weight

  13. adverse events

    Time frame: 12 weeks, 24 weeks

    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

  14. Microbiome Analysis

    Time frame: 12 weeks

    16s RNA sequencing

  15. cost-utility analysis

    Time frame: 12 weeks

    from EQ-5D-5L values quality adjustes life years (QUALYS) will be calulated to conduct cost-utility analysis from participants perspective

  16. Qualitative evaluation

    Time frame: 12 weeks

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Alina Moosburner, MSc

CONTACT

[email protected]

+4971181013764

Holger Cramer, Prof. Dr.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Collaborators

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

Registry information

Official study 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

Acronym: MEDIMIND

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 1, 2024
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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