Depressive Disorder, Major
Conditions
Keywords
depression, mediterranean diet, mindfulnes eating, nutrition, obesity
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.
Interventions
OTHERnutritional intervention
nutritional intervention to mediterranean diet
BEHAVIORALMindful Eating
intervention regarding mindful eating, e.g. attention while eating, apprechiation of food
OTHERAttention 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
Sponsors
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
University Hospital Tuebingen
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
data analysis will be conducted blinded
Intervention model description
2x2 factorial design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression severity | 12 weeks | Beck Depression Inventory - II (BDI-II) scores range from 0 to 63 with higher scores indicating higher depression severity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression severity, self assessment | 24 weeks | Beck Depression Inventory - II (BDI-II) scores range from 0 to 63 with higher scores indicating higher depression severity |
| Depression Remission Rates | 12 weeks, 24 weeks | rates of participants showing no depressive symptoms, defined as BDI-II less than 9 |
| Quality of Life | 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 |
| Health status | 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 |
| Adhernece to Mediterranean Diet | 12 weeks, 24 weeks | mediterranean diet adherence score (MEDAS) scores range from 0 to 14 with higher values indicating higher adherence to mediterranean diet |
| Adherence to Mindfulnes Eating | 12 weeks, 24 weeks | Mindfulness Eating Inventory (MEI), score ranges from 1 to 6, with higher scores indicating higher adherence to mindfulness eating |
| Depression severity, rater assesment | 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 |
| Self-efficacy | 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 |
| Waist to Hip ratio | 12 weeks, 24 weeks | ratio of weight circumference and hip circumference |
| Body composition: muscle mass | 12 weeks, 24 weeks | muscle mass as a percentage of body weight |
| Body composition: fat mass | 12 weeks, 24 weeks | fat mass as a percentage of body weight |
| adverse events | 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 |
| Microbiome Analysis | 12 weeks | 16s RNA sequencing |
| cost-utility analysis | 12 weeks | from EQ-5D-5L values quality adjustes life years (QUALYS) will be calulated to conduct cost-utility analysis from participants perspective |
| Qualitative evaluation | 12 weeks | Semi-structured interviews will consider two areas: 1. the perception on the intervention in terms of feasibility, difficulties in implementation, perception of study setting, planning of long-term implementation, etc. 2. perception of effects of interventions, qualitative evaluation of changes in outcoms, i.e. mood, psychological and physical well-being, self-efficacy, etc |
| BMI | 12 weeks, 24 weeks | weight and height will be combined to report BMI in kg/m\^2 |
Countries
Germany
Contacts
Primary ContactAlina Moosburner, MSc
Backup ContactHolger Cramer, Prof. Dr.
Outcome results
None listed