Exploring the Interplay Between Diet, Obesity, Mental Health, and the Gut Microbiome. The MIND-GUT Digital Pilot Intervention Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Study effectiveness: change in depression symptoms at follow-up
研究概览
简要总结
This 12-week pilot study aims to evaluate the feasibility and effectiveness of a dietary intervention targeting diet, obesity, mental health, and the gut microbiome in promoting weight loss and enhancing mental health among obese men and women aged 30-50. Participants, excluding those with specific medical conditions, will be randomly assigned to either an intervention or control group using a meal planning smartphone app. Clinical assessments will include anthropometry, mental health questionnaires, dietary recalls, and stool sample collections. The study's endpoints include program retention, adherence, changes in body weight, mental health, and gut microbiome diversity. Statistical analyses will evaluate intervention effects and the potential mediating roles of the gut microbiome. This pilot study has implications for health policies, public healthcare, digital health companies, and the biotech and pharmacology industries. Future plans involve a large-scale intervention study in multiple countries with ongoing collaborations.
详细描述
Objective of the Pilot Study and Study Design:
This 12-week randomized pilot intervention study aims to assess the feasibility and effectiveness of a dietary intervention targeting diet, obesity, mental health, and the gut microbiome in promoting weight loss and enhancing mental health among obese individuals aged 30-50.
Participant Recruitment and Randomization:
Participants aged 30-50, excluding those with specific medical conditions such as psychiatric medication use, food allergies affecting diets, eating disorders, diabetes, polycystic ovary syndrome, sensory deficits, recent antibiotic use, participation in other studies, language limitations, coeliac/inflammatory bowel disease, planned weight management within 3 months, and pregnant/lactating/post-menopausal women, will be recruited for the study. Randomization will be conducted to assign eligible participants to either an intervention or control group using a meal planning smartphone app.
Clinical Assessments:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants will be blinded to their group assignment and will use a smartphone app for meal planning. However, those in the intervention group may have some awareness of their assignment due to specific food choices. Meanwhile, the control group will have access to a variety of foods and recipes, maintaining blinding between the groups regarding their assigned diets, addressing a common challenge in diet intervention studies.
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 30- 50;
- •BMI ≥ 30 kg/m2;
- •stable physical activity;
- •one person per household;
- •commitment to full protocol.
排除标准
- •use of psychiatric medications (e.g., serotonin reuptake inhibitors);
- •use of weight loss medications (GLP-1 receptor agonists);
- •food allergies affecting adherence to the MIND diet;
- •diagnosis of eating disorders;
- •diagnosis of diabetes;
- •diagnosis of polycystic ovary syndrome;
- •sensory deficits (e.g., COVID-19-induced loss of taste/smell);
- •antibiotic use during the latest 3 months;
- •participation in another study;
- •language understanding limitations (i.e., not able to understand either Swedish or English); - coeliac/inflammatory bowel disease;
- •planned weight management program within three months;
- •pregnancy;
- •lactation;
- •menopause.
结局指标
主要结局
Study effectiveness: change in depression symptoms at follow-up
时间窗: 12 weeks
Comparison of PHQ-9 questionnaire at baseline vs. follow-up. The PHQ-9 is a tool to assist clinicians in identifying and diagnosing major depression. It has a maximum score of 27. Higher scores correspond to worst outcomes in terms of depression symtoms.
Study effectiveness: change in body weight at follow-up
时间窗: 12 weeks
Comparison of body weight at baseline vs. follow-up
Study effectiveness: change in % total fat mass at follow-up
时间窗: 12 weeks
Comparison of body % total fat mass at baseline vs. follow-up
Acceptability
时间窗: 12 weeks
Assessment of participants' experience of the program through qualitative interviews, focusing in particular on: Perception of and experience with the intervention, intervention components (dietary plans, use of the app, etc.), factors influencing participants' engagement, perceived impact on behavior and well-being, interaction with the staff, suggestions for improvement.
Study effectiveness: change in eating attitudes at follow-up
时间窗: 12 weeks
Comparison of a score calculated after administration of the EAT-26 questionnaire at baseline vs. follow-up. The EAT-26 comprises three subscales, namely, Dieting, Bulimia and Food Preoccupation, and Oral Control. Higher scores correspond to a worse outcome.
Study effectiveness: change in anxiety symtoms at follow-up
时间窗: 12 weeks
Comparison of GAD-7 questionnaire at baseline vs. follow-up. Each item is scored on a four-point Likert scale (0-3) with total scores ranging from 0 to 21 with higher scores reflecting worst outcomes in terms of anxiety severity.
Study effectiveness: change in % visceral fat mass at follow-up
时间窗: 12 weeks
Comparison of body % visceral fat at baseline vs. follow-up
Study effectiveness: change in microbiome variety at follow-up
时间窗: 12 weeks
Comparison of number and types of species at baseline vs. follow-up.
Program retention
时间窗: 12 weeks
Evaluation of participants' continued engagement in the program over time i.e., % of individuals completing the second and third 24h diet recall and % of participants returning to the second visit at the end of the intervention.
Study effectiveness: change in waist circumference at follow-up
时间窗: 12 weeks
Comparison of waist circumference at baseline vs. follow-up
Study effectiveness: change in hip circumference at follow-up
时间窗: 12 weeks
Comparison of hip circumference at baseline vs. follow-up
Adherence
时间窗: 12 weeks
Measurement of participants' compliance with the assigned diet and program through 24h recall interviews, assessed comparing reported intake frequencies of each food group with the recommended intake frequencies according to the principles of the MIND diet.
Study effectiveness: change in stress levels at follow-up
时间窗: 12 weeks
Comparison of PSS-4 questionnaire at baseline vs. follow-up. The PSS total score is calculated by reverse-coding the positive items and summing the scores for all items. The total scores range from 0 to 56, from 0 to 40, and from 0 to 16 for the PSS-14, PSS-10, and PSS-4, respectively. A higher score indicates more perceived stress.
次要结局
未报告次要终点
研究者
Gianluca Tognon
Senior lecturer in public health sciences
University of Skövde