Feasibility Of An Online Self-management Mediterranean Diet Program To Improve Dietary Behaviour And Quality Of Life For People Living With Parkinson's Disease: The MediPD Pilot Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Change in Mediterranean Diet Adherence using a Mediterranean Diet Score at 24 Weeks
研究概览
简要总结
The aim of this pilot study is to assess whether an online Mediterranean diet programme called MediPD is acceptable and practical for people living with Parkinson's disease, and whether it can help them make and maintain changes towards a Mediterranean-style diet.
The study will include 120 adults living in the United Kingdom with Parkinson's disease who have access to an internet-enabled device and currently have low adherence to a Mediterranean-style diet. Participants will be randomly assigned to one of two groups. One group will receive access to the MediPD online programme, which includes short educational videos, personalised dietary information, practical resources, goal-setting tools, and online dietetic support. The other group will continue with their usual care and will receive access to MediPD after completing the final study assessment.
Researchers will compare the groups to see whether MediPD improves adherence to a Mediterranean diet after 24 weeks. The study will also examine dietary intake, non-motor symptoms, quality of life, gastrointestinal symptoms, cognitive function, and how acceptable and practical the programme is to use. Assessments will take place at the start of the study, at 12 weeks, and at 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The Principal Investigator and statistician conducting the outcome analysis will remain blinded to treatment allocation. Participants cannot be blinded because of the nature of the online dietary intervention. Group allocation will be revealed to participants following completion of baseline assessments.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-reported idiopathic Parkinson's disease
- •Age 18 years or older
- •Community-dwelling and resident in the United Kingdom
- •Access to an internet-enabled device and an active email address
- •Mediterranean Diet Score ≤7/13, indicating low adherence to a Mediterranean diet
- •Proficient in English
- •Able to provide informed consent
排除标准
- •Atypical or secondary parkinsonism
- •Living in an institution
- •Self-reported body mass index <18.5 kg/m²
- •High risk of malnutrition, defined as MUST score ≥2
- •Receiving prescribed nutritional support
- •Significant cognitive impairment, defined as T-CogS ≤21
- •Pregnancy
- •Active inflammatory bowel disease
- •Dysphagia requiring a pureed diet
- •Food allergies that would prevent adherence to a Mediterranean-style diet
- •Following a vegan diet that would prevent adherence to the study's Mediterranean-style dietary intervention.
- •Current participation in another interventional trial
- •Participation in an investigational medicinal product trial within the previous 90 days where this may affect study outcomes or participant burden
- •Previous participation in a My Moves Matter dietary programme.
研究组 & 干预措施
MediPD Intervention
Participants will receive access to the 12-week MediPD online Mediterranean diet behaviour-change program
干预措施: MediPD Online Mediterranean Diet Program (Behavioral)
Wait-List Control
Participants will continue to receive their usual care. After completing the final 24-week study assessment, participants in the wait-list control group will be offered access to the MediPD online program for 12 weeks.
结局指标
主要结局
Change in Mediterranean Diet Adherence using a Mediterranean Diet Score at 24 Weeks
时间窗: Baseline to 24 weeks
Adherence to a Mediterranean diet will be assessed using the Mediterranean Diet Score (MDS), derived from a validated 14-item questionnaire. Total scores range from 0 to 14, with higher scores indicating greater adherence to a Mediterranean diet.
次要结局
- Change in Mediterranean Diet Adherence using a Mediterranean Diet Score at 12 Weeks(Baseline to 12 weeks)
- Change in self-reported dietary intake using a 24-hour Dietary Recall(Baseline, 12 weeks and 24 weeks.)
- Change in Parkinson's Disease Non-Motor Symptoms using the Movement Disorder Society Non-Motor Rating Scale (MDS-NMS)(Baseline, 12 weeks and 24 weeks.)
- Change in reported Gastrointestinal Symptoms using the Gastrointestinal Symptom Rating Scale (GSRS)(Baseline, 12 weeks and 24 weeks.)
- Change in quality of life using the Parkinson's Disease Questionnaire (PDQ-39)(Baseline, 12 weeks and 24 weeks.)
- Change in cognitive function using TestMyBrain cognitive test battery(Baseline, 12 weeks and 24 weeks.)
研究者
Claire McEvoy
Dr Claire McEvoy, PhD, Mphil, RD, Reader, Nutrition and Ageing Research
Queen's University, Belfast