Robert Bosch Center for Integrative Medicine and Health
Stuttgart, 70376, Germany
Location status: Recruiting
NCT Number: NCT06621394
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Stuttgart, 70376, Germany
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Healthy Volunteers:
samples of 32 healthy volunteers are included for microbiome analysis only (
Inclusion criteria
Exclusion criteria
-- intake of antibiotics in the last three months current substance abuse
nutritional intervention to mediterranean diet
intervention regarding mindful eating, e.g. attention while eating, apprechiation of food
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
Time frame: 12 weeks
Beck Depression Inventory - II (BDI-II) scores range from 0 to 63 with higher scores indicating higher depression severity
Time frame: 24 weeks
Beck Depression Inventory - II (BDI-II) scores range from 0 to 63 with higher scores indicating higher depression severity
Time frame: 12 weeks, 24 weeks
rates of participants showing no depressive symptoms, defined as BDI-II less than 9
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
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
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
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
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
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
Time frame: 12 weeks, 24 weeks
weight and height will be combined to report BMI in kg/m^2
Time frame: 12 weeks, 24 weeks
ratio of weight circumference and hip circumference
Time frame: 12 weeks, 24 weeks
muscle mass as a percentage of body weight
Time frame: 12 weeks, 24 weeks
fat mass as a percentage of body weight
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
Time frame: 12 weeks
16s RNA sequencing
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
Time frame: 12 weeks
Semi-structured interviews will consider two areas:
Contact information is provided by the study sponsor or research team.
Alina Moosburner, MSc
CONTACT
Holger Cramer, Prof. Dr.
CONTACT
University Hospital Tuebingen
Other
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
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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