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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'data analysis will be conducted blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': '2x2 factorial design'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-03', 'studyFirstSubmitDate': '2024-09-23', 'studyFirstSubmitQcDate': '2024-09-27', 'lastUpdatePostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depression severity', 'timeFrame': '12 weeks', 'description': 'Beck Depression Inventory - II (BDI-II) scores range from 0 to 63 with higher scores indicating higher depression severity'}], 'secondaryOutcomes': [{'measure': 'Depression severity, self assessment', 'timeFrame': '24 weeks', 'description': 'Beck Depression Inventory - II (BDI-II) scores range from 0 to 63 with higher scores indicating higher depression severity'}, {'measure': 'Depression Remission Rates', 'timeFrame': '12 weeks, 24 weeks', 'description': 'rates of participants showing no depressive symptoms, defined as BDI-II less than 9'}, {'measure': 'Quality of Life', 'timeFrame': '12 weeks, 24 weeks', 'description': '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'}, {'measure': 'Self-efficacy', 'timeFrame': '12 weeks, 24 weeks', 'description': 'general self-efficacy expectation scale, score ranges from 10 to 40, with a higher score indicating a greater expectation of self-efficacy'}, {'measure': 'Health status', 'timeFrame': '12 weeks,', 'description': "European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L), results in a 5-digit number that describes the patient's health state"}, {'measure': 'Adhernece to Mediterranean Diet', 'timeFrame': '12 weeks, 24 weeks', 'description': 'mediterranean diet adherence score (MEDAS) scores range from 0 to 14 with higher values indicating higher adherence to mediterranean diet'}, {'measure': 'Adherence to Mindfulnes Eating', 'timeFrame': '12 weeks, 24 weeks', 'description': 'Mindfulness Eating Inventory (MEI), score ranges from 1 to 6, with higher scores indicating higher adherence to mindfulness eating'}, {'measure': 'Depression severity, rater assesment', 'timeFrame': '12 weeks', 'description': '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'}, {'measure': 'BMI', 'timeFrame': '12 weeks, 24 weeks', 'description': 'weight and height will be combined to report BMI in kg/m\\^2'}, {'measure': 'Waist to Hip ratio', 'timeFrame': '12 weeks, 24 weeks', 'description': 'ratio of weight circumference and hip circumference'}, {'measure': 'Body composition: muscle mass', 'timeFrame': '12 weeks, 24 weeks', 'description': 'muscle mass as a percentage of body weight'}, {'measure': 'Body composition: fat mass', 'timeFrame': '12 weeks, 24 weeks', 'description': 'fat mass as a percentage of body weight'}, {'measure': 'adverse events', 'timeFrame': '12 weeks, 24 weeks', 'description': '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'}, {'measure': 'Microbiome Analysis', 'timeFrame': '12 weeks', 'description': '16s RNA sequencing'}, {'measure': 'cost-utility analysis', 'timeFrame': '12 weeks', 'description': 'from EQ-5D-5L values quality adjustes life years (QUALYS) will be calulated to conduct cost-utility analysis from participants perspective'}, {'measure': 'Qualitative evaluation', 'timeFrame': '12 weeks', 'description': 'Semi-structured interviews will consider two areas:\n\n1. the perception on the intervention in terms of feasibility, difficulties in implementation, perception of study setting, planning of long-term implementation, etc.\n2. perception of effects of interventions, qualitative evaluation of changes in outcoms, i.e. mood, psychological and physical well-being, self-efficacy, etc'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['depression', 'mediterranean diet', 'mindfulnes eating', 'nutrition', 'obesity'], 'conditions': ['Depressive Disorder, Major']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': False, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Presence of clinically diagnosed major depression\n* At least moderate depression severity: BDI-II ≥ 20\n* obesity: BMI ≥ 30 kg/m2\n* Stable co-intervention: no change in the type, dosage or frequency of antidepressant medication and/or psychotherapy four weeks before and during the study\n* Low adherence to the mediterranean diet: MEDAS \\< 10\n* Low adherence to mindful eating: MEI \\< 5.13\n\nExclusion Criteria:\n\n* Diseases of the gastrointestinal tract that do not allow adequate implementation of the intervention (e.g. irritable bowel syndrome, post-bariatric surgery, colorectal carcinoma)\n* Metabolic diseases with strong impact on intervention (e.g. type 1 diabetes mellitus, chronic kidney disease)\n* Severe food allergies and intolerances, that do not allow adequate implementation of the intervention\n* Diagnosed, current psychological comorbidities (bipolar disorder, eating disorder, personality disorder, psychosis)\n* intake of antibiotics in the last three months current substance abuse\n* Pregnancy and breatfeeding\n* Suicidal ideation\n* unable to participate or complete questionnaires\n\nHealthy Volunteers:\n\nsamples of 32 healthy volunteers are included for microbiome analysis only (\n\ninclusion criteria:\n\n* age ≥ 18 years\n* BMI 20 - 30 kg/m\\^2\n\nexclusion criteria:\n\n* depression or other psychological comorbidities (bipolar disorder, eating disorder, personality disorder, psychosis)\n* high adhernece to mediterranean diet: MEDAS ≥ 10\n* high adherence to mindful eating: MEI ≥ 5.13\n* Diseases of the gastrointestinal tract or metabilic diseases (e.g. irritable bowel syndrome, post-bariatric surgery, colorectal carcinoma, type 1 diabetes mellitus)\n\n \\-- intake of antibiotics in the last three months current substance abuse\n* pregnancy or breastfeeding'}, 'identificationModule': {'nctId': 'NCT06621394', 'acronym': 'MEDIMIND', 'briefTitle': 'The Effect of Mediterranean Diet and Mindfulness Eating on Depression Severity in People With Obesity and Major Depressive Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'medimind'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mediterranean Diet', 'interventionNames': ['Other: nutritional intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Mindful Eating', 'interventionNames': ['Behavioral: Mindful Eating']}, {'type': 'EXPERIMENTAL', 'label': 'Mediterranean Diet and Mindful Eating', 'interventionNames': ['Other: nutritional intervention', 'Behavioral: Mindful Eating']}, {'type': 'SHAM_COMPARATOR', 'label': 'Befriending', 'interventionNames': ['Other: Attention Control']}], 'interventions': [{'name': 'nutritional intervention', 'type': 'OTHER', 'description': 'nutritional intervention to mediterranean diet', 'armGroupLabels': ['Mediterranean Diet', 'Mediterranean Diet and Mindful Eating']}, {'name': 'Mindful Eating', 'type': 'BEHAVIORAL', 'description': 'intervention regarding mindful eating, e.g. attention while eating, apprechiation of food', 'armGroupLabels': ['Mediterranean Diet and Mindful Eating', 'Mindful Eating']}, {'name': 'Attention Control', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['Befriending']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70376', 'city': 'Stuttgart', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Alina Moosburner', 'role': 'CONTACT', 'email': 'alina.moosburner@med.uni-tuebingen.de', 'phone': '071181013764'}], 'facility': 'Robert Bosch Center for Integrative Medicine and Health', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}], 'centralContacts': [{'name': 'Alina Moosburner, MSc', 'role': 'CONTACT', 'email': 'alina.moosburner@med.uni-tuebingen.de', 'phone': '+4971181013764'}, {'name': 'Holger Cramer, Prof. Dr.', 'role': 'CONTACT', 'email': 'holger.cramer@med.uni-tuebingen.de'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Robert Bosch Center for Integrative Medicine and Health', 'class': 'UNKNOWN'}, {'name': 'Department of Psychosomatic Medicine, Robert Bosch Hospital Stuttgart', 'class': 'UNKNOWN'}, {'name': 'Microbial Genetics, Interfaculty Institute of Microbiology and Infection Medicine Tübingen, University of Tübingen', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}