McGrattan Andrea M, McEvoy Claire T, Vijayakumar Aswathy, Moore Sarah E, Neville Charlotte E, McGuinness Bernadette, McKinley Michelle C, Woodside Jayne V
Centre for Public Health, Queens University Belfast, Belfast, BT12 6BJ, UK.
Pilot Feasibility Stud. 2021 Jan 4;7(1):3. doi: 10.1186/s40814-020-00738-3.
Accumulating evidence supports the role of a Mediterranean diet (MD) in cognition, with a greater adherence to a MD associated with reduced dementia risk. It is important to understand how best to achieve behaviour change towards a MD, particularly in non-Mediterranean and high-risk populations. The aim of this study was to evaluate the feasibility of a MD and lifestyle education intervention (THINK-MED) among older adults with cognitive impairment.
Qualitative interviews (Phase I), conducted with mild cognitive impairment (MCI) participants, evaluated the intervention materials to allow refinement before pilot testing. THINK-MED was a 12-month, pilot RCT (Phase II) whereby MCI participants were randomised into one of three groups: education on one occasion vs education staged and supported by a dietitian vs control. The primary outcome was a change in MD score. Secondary outcome measurements were collected to gather data on variability of the outcomes to inform a full trial power calculation and to test their acceptability. Slower recruitment rates necessitated a change in primary outcome to a revised focus primarily on feasibility. A sub-study of the same THINK-MED intervention and data collection measures was also conducted among community-dwelling participants with subjective cognitive impairment (SCI) (NCT03569319).
A total of 20 participants (n = 15 MCI; n = 5 SCI) were enrolled in the THINK-MED study. However, there were 10 (50%) participants (n = 9 MCI; n = 1 SCI) who withdrew from the study. Although, those who remained in the intervention rated and evaluated their experience as generally positive, recruitment and retention, especially from a MCI population, was extremely challenging. This highlights the complex needs of this heterogeneous clinical cohort. Recruiting participants from a community-based sample with SCI was more feasible, reaching a wider audience in a shorter time period. There were challenges relating to data collection and incompleteness, with the occurrence of missing data particularly among the questionnaire-based assessments.
Owing to the challenges with recruitment and retention of older adults with cognitive impairment in this study, it is difficult to confirm if this intervention is feasible. This research has highlighted considerations for a future trial, including a review of the recruitment strategies used and prioritisation of the outcome measures assessed.
Clinical trials registration NCT03265522 / NCT03569319.
越来越多的证据支持地中海饮食（MD）在认知方面的作用，对地中海饮食的更高依从性与降低痴呆风险相关。了解如何最好地实现向地中海饮食的行为改变非常重要，特别是在非地中海地区和高风险人群中。本研究的目的是评估针对认知障碍老年人的地中海饮食与生活方式教育干预（THINK-MED）的可行性。
对轻度认知障碍（MCI）参与者进行定性访谈（第一阶段），评估干预材料以便在试点测试前进行完善。THINK-MED是一项为期12个月的试点随机对照试验（第二阶段），MCI参与者被随机分为三组之一：一次性教育组、由营养师分阶段提供支持的教育组和对照组。主要结局是地中海饮食评分的变化。收集次要结局测量数据，以获取关于结局变异性的数据，为全面试验的功效计算提供信息，并测试其可接受性。招募率较低使得主要结局改为主要关注可行性的修订重点。在有主观认知障碍（SCI）的社区居住参与者中也进行了一项关于相同THINK-MED干预和数据收集措施的子研究（NCT03569319）。
共有20名参与者（n = 15名MCI；n = 5名SCI）纳入THINK-MED研究。然而，有10名（50%）参与者（n = 9名MCI；n = 1名SCI）退出了研究。尽管留在干预组的参与者对他们的体验评价总体为积极，但招募和留住参与者，尤其是来自MCI人群的参与者极具挑战性。这凸显了这个异质性临床队列的复杂需求。从基于社区的SCI样本中招募参与者更可行，能在更短时间内覆盖更广泛的人群。在数据收集和不完整性方面存在挑战，尤其是在基于问卷的评估中出现了数据缺失。
由于本研究在招募和留住认知障碍老年人方面存在挑战，难以确定该干预措施是否可行。这项研究突出了对未来试验的考虑，包括对所采用的招募策略进行审查以及对评估的结局指标进行优先级排序。
临床试验注册编号NCT03265522 / NCT03569319。
