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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Depression severity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
data analysis will be conducted blinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Depression severity
时间窗: 12 weeks
Beck Depression Inventory - II (BDI-II) scores range from 0 to 63 with higher scores indicating higher depression severity
次要结局
- Depression severity, self assessment(24 weeks)
- Depression Remission Rates(12 weeks, 24 weeks)
- Quality of Life(12 weeks, 24 weeks)
- Self-efficacy(12 weeks, 24 weeks)
- Health status(12 weeks,)
- Adhernece to Mediterranean Diet(12 weeks, 24 weeks)
- Adherence to Mindfulnes Eating(12 weeks, 24 weeks)
- Depression severity, rater assesment(12 weeks)
- BMI(12 weeks, 24 weeks)
- Waist to Hip ratio(12 weeks, 24 weeks)
- Body composition: muscle mass(12 weeks, 24 weeks)
- Body composition: fat mass(12 weeks, 24 weeks)
- adverse events(12 weeks, 24 weeks)
- Microbiome Analysis(12 weeks)
- cost-utility analysis(12 weeks)
- Qualitative evaluation(12 weeks)