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NCT Number: NCT05342896

Effect of Mediterranean-DASH Intervention for Neurodegenerative Delay Plus Forest Bathing

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.

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Key information

Conditions

High Blood Pressure Cardiovascular Diseases Hypertension Vascular Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Queenie Law

Hong Kong

About this study

Research aim

  • This study will aim to investigate the effect of MIND and MIND plus FB on hypertension.
  • To examine the effect of MIND alone on hypertension by controlling other covariates.
  • To describe the perceived capability, opportunity, and motivation to the uptake of the MIND and FB.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

MIND diet

Behavioral

MIND diet intervention will be a 3-month nutrition programme consisting of 4 face-to-face nutrition counselling sessions (one session per week, 60 min per session) in the activity room of each participating community centre. All intervention sessions will be conducted by a registered nutritionist and trained student helpers. In the nutrition sessions, the participants will learn to modify their diet to meet MIND diet guidelines.

Mind diet plus Forest Bathing

Behavioral

MIND diet intervention will be a 3-month nutrition programme consisting of 4 face-to-face nutrition counselling sessions (one session per week, 60 min per session) in the activity room of each participating community centre. All intervention sessions will be conducted by a registered nutritionist and trained student helpers. In the nutrition sessions, the participants will learn to modify their diet to meet MIND diet guidelines. Forest Bathing will be another session per week, 2 hours forest bathing sessions on 4-consecutive weekends in a country park at daytime with sunny, cloudy or drizzling conditions. The walking distance for each forest bathing is one to two kilometres. The coach-to-participant ratio is approximately 1:16. Participants will then be required to self-practice 2h FB in the country park at daytime at the weekends of 8th week and 12th week of the intervention.

Primary outcomes

  1. Change in Blood pressure

    Time frame: Three months

    By systolic blood pressure, measured by a digital automatic device

Secondary outcomes

  1. Change in lipid panel of HDL cholesterol, triglycerides and LDL cholesterol

    Time frame: Three months

    By point of care test (POCT) of lipid panel (HDL-cholesterol, triglycerides and LDL-cholesterol)

  2. Change in body fat percentages

    Time frame: Three months

    By body fat percentages, measured by bioelectrical impedance analysis

  3. Change in cognitive function

    Time frame: Three months

    By cognitive function, measured by Hong Kong version of the Montreal Cognitive Assessment, cut-off score of 21/22 after adjustment of education level is recommended as indication for further evaluation of cognitive impairment and dementia. Lower scores mean worse outcome. The minimum score is 0 and maximum score is 30.

  4. Change in waist circumference

    Time frame: Three months

    By waist circumference, measured by tape meter between the lower rib and iliac crest

  5. Change in diet scores

    Time frame: Three months

    By diet scores, measured by total scores using predefined criteria of MIND diet. A value of 0.0, 0.5, or 1.0 is assigned to each food group. For high intake of brain healthy food group, participants will receive a score of 1 and the score is reversed for unhealthy food group. The total MIND diet score will be computed by summing all food groups eaten, with a maximum score of 15 representing the highest adherence to the MIND diet.

Sponsors and collaborators

Lead sponsor

Hong Kong Metropolitan University

Other

Registry information

Official study title

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

Acronym: MINDdiet

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Apr 25, 2022
Registry last updated
Nov 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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