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临床试验/NCT05342896
NCT05342896已完成不适用

Effect of Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Plus Forest Bathing (FB) on Blood Pressure and Cognitive Health for Those Who Are Aged 50 and Above With Hypertension

Hong Kong Metropolitan University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2021年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
主要终点
Change in Blood pressure

研究概览

简要总结

This proposed study will be the first to investigate the effect of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Plus Forest Bathing (FB) on blood pressure (BP) and cognitive health for those who are aged 50 and above with hypertension. Hypertension is a major public health issue, and four developments make this research study remarkably important.

It is well-documented the Mediterranean diet and Dietary Approach to Stop Hypertension (DASH) diet have demonstrated efficacy for improving cardiovascular and cognitive health. The Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet is a hybrid of the Mediterranean and DASH diets. FB promotes relaxation by inducing the activity of the parasympathetic nervous system, which decrease Heart rate and BP. The initial quantitative phase of the study, a three-arm RCT will be conducted to examine the effects of MIND, MIND plus FB and usual care as control on hypertension. The subsequent qualitative phase in-depth focus group interview is to explore the barriers and facilitators of MIND diet uptake and FB. The participants will include older HK Chinese adults who meet the criteria for hypertension stage 1 and stage 2 of the AHA. The primary outcomes are systolic BP and the secondary outcomes are point of care test of lipid panel, cognitive function, waist-to-hip ratio, body fat percentages and body mass index. The outcome measurements will be recorded before the interventions (T0), immediately after the 4-week face-to-face intervention (T1) and 12-week after 3-month intervention (T2). A total of 48 those who are aged 50 and above with hypertension will be recruited from community centres in Hong Kong to Randomized Controlled Trial and 10 participants differing in levels of compliance to MIND and FB will be purposively selected for face-to-face semi-structured focus group interviews.

详细描述

Research aim

  1. This study will aim to investigate the effect of MIND and MIND plus FB on hypertension.
  2. To examine the effect of MIND alone on hypertension by controlling other covariates.
  3. To describe the perceived capability, opportunity, and motivation to the uptake of the MIND and FB.
  4. To explore the barriers and facilitators to the MIND and FB.

The MIND-FB is proposed in response to (i) high BP is the one of important risk factors for chronic diseases. (ii) although there is robust evidence to show that the important of lowering BP to reduce chance of getting cardiovascular morbidity and mortality, the global burden of hypertension is still increasing. The objectives of MIND-FB are to perform high quality research focused on those who are aged 50 and above, novel transdisciplinary approaches to ensure the building capacity of public health workforce to deliver quality lifestyle modification intervention to control BP of those who are aged 50 and above.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

It will be a single-blind trial; only the assessors will be blinded to the treatment assignment.

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • aged 60 and above;
  • Chinese ethnicity;
  • ability to speak and understand Chinese;
  • fulfilment of the AHA criteria for stage 1 and stage 2 hypertension; and
  • who could walk independently

排除标准

  • have allergy to more than one type of food (nuts, berries, olive oil, or fish);
  • participation in any dietary or relaxation programme within the past 3 months

结局指标

主要结局

Change in Blood pressure

时间窗: Three months

By systolic blood pressure, measured by a digital automatic device

次要结局

  • Change in lipid panel of HDL cholesterol, triglycerides and LDL cholesterol(Three months)
  • Change in body fat percentages(Three months)
  • Change in cognitive function(Three months)
  • Change in waist circumference(Three months)
  • Change in diet scores(Three months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Queenie Law Pui Sze

Associate Professor

Hong Kong Metropolitan University

研究点 (1)

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