Depressive Disorder, MajorMEDIMINDNCT06621394
The Effect of Mediterranean Diet and Mindfulness Eating on Depression Severity in People With Obesity and Major Depressive Disorder
A study testing nutritional intervention and Mindful Eating in people with Depressive Disorder, Major, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- nutritional intervention and Mindful Eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteGermany
- Study dates
- 5 Nov 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Low adherence to mindful eating: MEI < 5.13
- age ≥ 18 years
- BMI 20 - 30 kg/m^2
Who cannot join
- 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
Show all 16Show fewer
- Suicidal ideation
- unable to participate or complete questionnaires
- Healthy Volunteers:
- samples of 32 healthy volunteers are included for microbiome analysis only (
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Holger Cramer, Prof. Dr. contact
Germany1 site, 1 recruiting
- Recruiting
Robert Bosch Center for Integrative Medicine and Health
Stuttgart, 70376
Alina Moosburner, 071181013764, alina.moosburner@med.uni-tuebingen.de
About this study
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
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.
Read the 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
- Being tested
- nutritional intervention, Mindful Eating, Attention Control
- Keywords
- depression, mediterranean diet, mindfulnes eating, nutrition, obesity
- Medical subject headings
- Depressive Disorder, Major, Depression, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutritional interventionOther
nutritional intervention to mediterranean diet
Mindful EatingBehavioural
intervention regarding mindful eating, e.g. attention while eating, apprechiation of food
Attention ControlOther
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
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean Diet | Experimental | Not described Receives: Other: nutritional intervention |
| Mindful Eating | Experimental | Not described Receives: Behavioral: Mindful Eating |
| Mediterranean Diet and Mindful Eating | Experimental | Not described Receives: Other: nutritional intervention; Behavioral: Mindful Eating |
| Befriending | Sham comparator | Not described Receives: Other: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression severity
Beck Depression Inventory - II (BDI-II) scores range from 0 to 63 with higher scores indicating higher depression severity
Measured: 12 weeks
Secondary outcomes (16)
Depression severity, self assessment
Beck Depression Inventory - II (BDI-II) scores range from 0 to 63 with higher scores indicating higher depression severity
Measured: 24 weeks
Depression Remission Rates
rates of participants showing no depressive symptoms, defined as BDI-II less than 9
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 weeks, 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
Measured: 12 weeks
BMI
weight and height will be combined to report BMI in kg/m^2
Measured: 12 weeks, 24 weeks
Waist to Hip ratio
ratio of weight circumference and hip circumference
Measured: 12 weeks, 24 weeks
Body composition: muscle mass
muscle mass as a percentage of body weight
Measured: 12 weeks, 24 weeks
Body composition: fat mass
fat mass as a percentage of body weight
Measured: 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
Measured: 12 weeks, 24 weeks
Microbiome Analysis
16s RNA sequencing
Measured: 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
Measured: 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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start5 Nov 2024
- Primary completion1 Mar 2025
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2x2 factorial design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621394
- Sponsor's protocol ID
- medimind
- Acronym
- MEDIMIND
- Status last verified
- Nov 2024
- First submitted
- 23 Sep 2024
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06621394
- Acronym / sponsor ID
- MEDIMIND / medimind
- Conditions
- Depressive Disorder, Major
- Keywords
- depression, mediterranean diet, mindfulnes eating, nutrition, obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- 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 start
- 5 Nov 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- 2x2 factorial design
| Arm | Type | Receives |
|---|---|---|
| Mediterranean Diet | Experimental | Other: nutritional intervention |
| Mindful Eating | Experimental | Behavioral: Mindful Eating |
| Mediterranean Diet and Mindful Eating | Experimental | Other: nutritional intervention, Behavioral: Mindful Eating |
| Befriending | Sham comparator | Other: Attention Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nutritional interventionnutritional intervention to mediterranean diet | Other | Mediterranean Diet, Mediterranean Diet and Mindful Eating |
| Mindful Eatingintervention regarding mindful eating, e.g. attention while eating, apprechiation of food | Behavioural | Mediterranean Diet and Mindful Eating, Mindful Eating |
| Attention ControlBefreinding Control Group: Provision of same amout of time and attention, without having an intervention, e.g. talking about hobbies and interests, playing card games | Other | Befriending |
Primary outcome
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
16 secondary outcomes
Depression severity, self assessment
Time frame: 24 weeks
Depression Remission Rates
Time frame: 12 weeks, 24 weeks
Quality of Life
Time frame: 12 weeks, 24 weeks
Self-efficacy
Time frame: 12 weeks, 24 weeks
Health status
Time frame: 12 weeks,
Adhernece to Mediterranean Diet
Time frame: 12 weeks, 24 weeks
Adherence to Mindfulnes Eating
Time frame: 12 weeks, 24 weeks
Depression severity, rater assesment
Time frame: 12 weeks
BMI
Time frame: 12 weeks, 24 weeks
Waist to Hip ratio
Time frame: 12 weeks, 24 weeks
Body composition: muscle mass
Time frame: 12 weeks, 24 weeks
Body composition: fat mass
Time frame: 12 weeks, 24 weeks
adverse events
Time frame: 12 weeks, 24 weeks
Microbiome Analysis
Time frame: 12 weeks
cost-utility analysis
Time frame: 12 weeks
Qualitative evaluation
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Holger Cramer, Prof. Dr. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nutritional intervention and Mindful Eating in people with Depressive Disorder, Major, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alina Moosburner, MSc (+4971181013764, alina.moosburner@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression severity (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.