Efficacy of a Culturally-adapted Mediterranean Diet Intervention on Depression in Relation to the Gut Microbiome: A Randomised Controlled Trial Using the Experience Sampling Methodology
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in the Patient Health Questionnaire-9 (PHQ-9)
研究概览
简要总结
The objective of this study is to investigate the efficacy of a culturally-adapted Mediterranean diet, in accordance with clinical guidelines and research evidence, in reducing depressive symptoms among Hong Kong Chinese adults. Additionally, this study will also explore the potential underlying role of the gut microbiome in the relationship between the Mediterranean diet and depression. This study serves as a pioneering attempt to examine the efficacy and intervention acceptability of a culturally-adapted Mediterranean diet in managing depressive symptoms.
Several studies have demonstrated the relationship between diet and mood, while existing studies suggest that consistently adhering to the Mediterranean diet may yield a more pronounced antidepressant effect. Considering that depression is often associated with low motivation, dietary interventions that require active participation may encounter implementation challenges and potentially impact the adherence rate. To address this issue, our study proposes using ecological momentary assessment (EMA), which involves sending frequent reminders to participants, allowing us to examine diet quality and adherence as well as changes in depressive symptoms at various time points. This approach also minimizes potential recall bias and enhances data collection accuracy. If the hypothesis is supported, dietary intervention could emerge as a promising therapeutic strategy for alleviating depressive symptoms. Furthermore, this study could provide insights into the role of the gut microbiome as a potential underlying mechanism between diet and depressive symptoms. The findings could have significant implications for clinical practice.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hong Kong residents aged 18-65 years;
- •Able to read Chinese and type in Chinese or English;
- •Have a Patient Health Questionnaire-9 (PHQ-9) score of 10 or higher, indicating at least a moderate level of depressive symptoms;
- •Meet the Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnostic criteria for current MDD according to the Mini International Neuropsychiatric Interview (MINI);
- •Have a Mediterranean Diet Index (KIDMED 2.0) score less than 3, indicating very-low-quality diet;
- •Possess an Internet-enabled iOS- or Android-operated mobile device; and
- •Willing to provide informed consent and comply with the trial protocol.
排除标准
- •The presence of other current psychiatric disorders as assessed by the MINI (bipolar disorder, posttraumatic stress disorder, personality disorders, eating disorders, psychotic disorders, or substance abuse disorder);
- •Have a medical condition or neurocognitive disorder that may prevent dietary changes as recommended by physicians or dietitians;
- •Current serious suicidal risk (non-fleeting intent or plan) as assessed by a PHQ-9 Item 9 score >2 (referral information to professional mental health services will be provided);
- •Involvement in dietary changes (self-initiated/supervised by professionals) in the past 2 weeks;
- •Involvement in any psychological treatment specifically for depression in the past 6 months;
- •A change in medication within 2 weeks prior to the baseline assessment/during the study;
- •Pregnancy and hospitalization;
- •Current participation in any other trial(s); and
- •Unwilling to change their diet if being allocated to the MediDiet group or food allergies or intolerances preventing diet adherence (specifically allergies to seafood, soy, nuts, yogurt, or dairy products).
研究组 & 干预措施
Mediterranean diet (MediDiet) group
Participants in MediDiet group will receive a culturally adapted Mediterranean diet prepared by the research team on a daily basis. This diet is designed by a certified dietitian based on clinical guidelines and research evidence. Participants will follow the intervention for a duration of four consecutive weeks.
干预措施: Mediterranean Diet (Dietary Supplement)
Care-as-usual (CAU) group
Participants in the CAU group will be instructed to maintain their usual dietary habits throughout the study period and will not receive any specially prepared Mediterranean diet from the research team. In addition, they will have access to care based on their needs and preferences, such as pharmacological interventions, psychological interventions, and complementary and alternative medicine. An intervention tracking log will be used to monitor the care the participants received to prevent violations of the study protocol. The CAU group will be given lifestyle-based self-help materials after the completion of follow-up assessments.
结局指标
主要结局
Change in the Patient Health Questionnaire-9 (PHQ-9)
时间窗: Baseline, immediate post-intervention, and 12-week follow-up
The PHQ-9 is a 9-item questionnaire used for screening, diagnosing, monitoring and measuring the severity of depression, which scores each of the nine DSM-IV criteria from "0" (not at all) to "3" (nearly every day).
次要结局
- Change in the adapted version of the Modified Mediterranean Diet Score (ModiMedDiet Score)(Baseline, immediate post-intervention, and 12-week follow-up)
- Change in the Generalized Anxiety Disorder 7-item Scale (GAD-7)(Baseline, immediate post-intervention, and 12-week follow-up)
- Change in the Insomnia Severity Index (ISI)(Baseline, immediate post-intervention, and 12-week follow-up)
- Change in the Seven-day Food Record (7dFR)(Baseline, immediate post-intervention, and 12-week follow-up)
- Change in the International Physical Activities Questionnaire-Chinese version (IPAQ-C)(Baseline, immediate post-intervention, and 12-week follow-up)
- Change in the Short Form (Six-Dimension) Health Survey (SF-6D)(Baseline, immediate post-intervention, and 12-week follow-up)
- Change in the Sheehan Disability Scale (SDS)(Baseline, immediate post-intervention, and 12-week follow-up)
- Change in the Treatment Acceptability Scale (TAS)(Baseline and immediate post-intervention)
- Change in the Credibility-Expectancy Questionnaire (CEQ)(Baseline and immediate post-intervention)
- Change in gut microbiome(Baseline and immediate post-intervention)
- Self-developed Survey(Baseline)
研究者
Fiona YY Ho
Associate Professor
Chinese University of Hong Kong