The Development and Pilot Testing of Tailored Mediterranean Lifestyle Education to Encourage Behaviour Change in Participants With Subjective Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change in Mediterranean Diet Score (MDS) at 6 months
研究概览
简要总结
It is estimated that 30% of Alzheimer's disease cases globally are associated with changeable risk factors, such as diet and physical activity. In particular, a Mediterranean diet (MD) has been associated with reduced risk of cognitive decline and improved brain function.
The investigators developed educational resources on the Mediterranean diet and lifestyle (THINK-MED) in accordance with the Medical Research Council guidance for developing and evaluating complex interventions, based on a systematic literature review and informed by qualitative work with patients with mild memory problems.The feedback gathered informed refinements and tailoring of the resource and overall MD intervention.
This study aims to evaluate feasibility of the "THINK-MED" Mediterranean lifestyle educational intervention to encourage dietary behaviour change among community-dwelling people with subjective cognitive impairment.
详细描述
This pilot RCT aims to evaluate the feasibility of a theory-based, tailored Mediterranean lifestyle education intervention (THINK-MED) to encourage behaviour change among participants who have subjective cognitive impairment.
This study will be a 6 month randomised controlled trial (RCT) with a total of 30 participants who will be randomised to 1 of 3 groups:
- Group 1 will receive the "THINK-MED" Mediterranean Lifestyle Education for Memory resource on one occasion at baseline (n=10)
- Group 2 will receive the "THINK-MED" Mediterranean Lifestyle Education for Memory resource at monthly intervals for 5 months, with an initial face-to-face visit from the research dietitian (month 1) and accompanied by telephone feedback (month 2-5) (n=10)
- Group 3 is a control group. Participants in this group will receive the "THINK-MED" Mediterranean Lifestyle Education for Memory resource after completing the 6 month study (n=10)
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
- •Have subjective cognitive impairment - Montreal Cognitive Assessment (MoCA) score ≥ 26/30
- •Mediterranean diet score (MDS) ≤ 4 (Estruch et al. 2006)
- •Willing to make changes to their diet
排除标准
- •Diagnosis of dementia
- •MoCA score of ≤ 25/30
- •Individuals with a visual or English language impairment
- •Psychiatric problems e.g. depression
- •Significant medical comorbidity
- •Body Mass Index (BMI) ≤ 19 and ≥ 40 kg/m2
- •Excessive alcohol consumption
- •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 with a increase in score by greater than or equal to 3 points at 6 months indicating adoption (maximum score 14)
次要结局
- Anthropometric measurements(Baseline, 6 months)
- Geriatric Depression Scale(Baseline, 6 months)
- Functional Assessment (1)(Baseline, 6 months)
- Rand Short Form-36 HEALTH SURVEY(Baseline, 6 months)
- Mediterranean Diet self-efficacy questionnaire(Baseline, 6 months)
- Change in Physical Activity at 6 months(Baseline, 6 months)
- Muscle Strength(Baseline, 6 months)
- Functional Assessment (2)(Baseline, 6 months)
- Cognitive Assessment(Baseline, 6 months)
- 4 day food diary(Baseline, 6 months)
- Mediterranean Diet Knowledge questionnaire(Baseline, 6 months)
- Dietary Quality of Life questionnaire(Baseline, 6 months)
- Staging Algorithm Questionnaire(Baseline, 6 months)
- Change in Lifestyle questionnaire(Baseline, 6 months)
- Blood Sample(Baseline, 6 months)
- Barriers to consuming a Mediterranean Diet questionnaire(Baseline, 6 months)
研究者
Jayne Woodside, PhD
Professor
Queen's University, Belfast