The Development and Pilot Testing of Tailored Mediterranean Lifestyle Education to Encourage Behaviour Change in Patients With Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in Mediterranean Diet Score (MDS) at 6 months
研究概览
简要总结
Evidence suggests that a Mediterranean diet can have a beneficial effect on brain health. Mild cognitive impairment (MCI) describes problems with brain function such as difficulty with day-to-day memory and concentration. It is at this stage that Mediterranean diet could prove beneficial in terms of prevention.
Previous research by Queens University investigated the opinions of patients with MCI and their care givers to inform the development of Mediterranean diet education material to encourage behaviour change. The study suggested that MCI patients lacked awareness of the link between Mediterranean diet and brain function, although were interested to learn more. Feedback on the developed educational material was positive although there were suggested improvements such as tailoring information to memory loss, a potential staged approach to delivery and adaptations to the material content.
This present study aims to pilot test refined educational material among MCI participants to evaluate the feasibility of encouraging dietary behaviour change among this patient group.
详细描述
This study aims to evaluate the feasibility of a theory-based, tailored Mediterranean lifestyle education intervention to encourage behaviour change in patients with MCI. The proposed study will be a 6 month RCT with a total of 60 MCI patients who will be randomised to 1 of 3 groups:
- Group 1 will receive the Mediterranean lifestyle education resource on one occasion at baseline
- Group 2 will receive the Mediterranean lifestyle education resource at monthly intervals for 5 months accompanied by telephone feedback from the research dietitian
- Group 3 will receive standard care (control group). Participants will receive the Mediterranean lifestyle education resource after their final 6 month study visit (i.e. delayed intervention).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Diagnosis of dementia
- •Patients with visual or English language impairment
- •Psychiatric problems
- •Significant medical comorbidity
- •Body Mass Index (BMI) ≤ 19 and ≥ 40 kg/m2
- •Excessive alcohol consumption
- •Taking high dose nutritional supplements
- •Dietary restrictions/allergies that would substantially limit ability to complete study requirements
- •Inability to provide informed consent
- •History of, or comorbid condition which may alter performance on cognitive tests e.g. stroke, head injury, Parkinson's disease, learning disability
结局指标
主要结局
Change in Mediterranean Diet Score (MDS) at 6 months
时间窗: Baseline, 6 months
Mediterranean dietary intake will be measured by a validated questionnaire
次要结局
- Muscle Strength(Baseline, 6 months)
- Geriatric Depression Scale(Baseline, 6 months)
- Barriers to consuming a Mediterranean Diet questionnaire(Baseline, 6 months)
- 4-day Food Diary(Baseline, 6 months)
- Mediterranean diet tolerance questionnaire(Baseline, 6 months)
- Mediterranean Diet self-efficacy questionnaire(Baseline, 6 months)
- Functional Assessment (1)(Baseline, 6 months)
- Blood Sample(Baseline, 6 months)
- Functional Assessment (2)(Baseline, 6 months)
- Rand SF-36 HEALTH SURVEY(Baseline, 6 months)
- Physical Activity(Baseline, 6 months)
- Anthropometric measurements(Baseline, 6 months)
- Cognitive Assessment(Baseline, 6 months)
- Change in Lifestyle questionnaire(Baseline, 6 months)
- Dietary Quality of Life questionnaire(Baseline, 6 months)
- Mediterranean Diet Knowledge questionnaire(Baseline, 6 months)
- Staging Algorithm Questionnaire(Baseline, 6 months)
研究者
Jayne Woodside, PhD
Professor
Queen's University, Belfast