Clinical trial NCT05342896: Effect of Mediterranean-DASH Intervention for Neurodegenerative Delay Plus Forest Bathing
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Blood Pressure
Keywords: High Blood Pressure
MIND diet
Forest Bathing
Lead sponsor: Hong Kong Metropolitan University
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 48
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Blood pressure
timeFrame: Three months
Secondary outcomes:
measure: Change in lipid panel of HDL cholesterol, triglycerides and LDL cholesterol
timeFrame: Three months
measure: Change in body fat percentages
timeFrame: Three months
measure: Change in cognitive function
timeFrame: Three months
measure: Change in waist circumference
timeFrame: Three months
measure: Change in diet scores
timeFrame: Three months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Dr. Queenie Law
Study officials:
References:
citation: 1. Morris M C., Tangney CC, Wang Y, Sacks FM, Barnes LL, Bennett, DA, & Aggarwal N T. MIND diet slows cognitive decline with aging. Alzheimer's and Dementia. 2015. 11(9): 1015-1022. 2. Morris MC, Tangney CC, Wang Y, Sacks FM, Bennett DA, & Aggarwal NT. MIND diet associated with reduced incidence of Alzheimer's disease. Alzheimer's and Dementia. 2015. 11(9): 1007-1014. 3. Aminianfar A, Hassanzadeh Keshteli A, Esmaillzadeh A, & Adibi P. Association between adherence to MIND diet and general and abdominal obesity: A cross-sectional study. Nutrition Journal. 2020. 19(1): 1-9. 4. Arjmand G, Abbas-Zadeh M, & Eftekhari MH. Effect of MIND diet intervention on cognitive performance and brain structure in healthy obese women: A randomized controlled trial. In bioRxiv. bioRxiv. 2020.