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

Sponsor
Hong Kong Metropolitan University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05342896
Collaborator
(none)
48
Enrollment
1
Location
3
Arms
21.9
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: MIND diet
  • Behavioral: Mind diet plus Forest Bathing
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
It will be a single-blind trial; only the assessors will be blinded to the treatment assignment.
Primary Purpose:
Health Services Research
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
Actual Study Start Date :
Jan 3, 2021
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Oct 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: MIND diet intervention

3-month intervention of dietary counseling to adhere to the MIND diet

Behavioral: MIND diet
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.
Experimental: MIND-plus-FB intervention

3-month intervention of dietary counseling to adhere to the MIND diet plus Forest Bathing intervention

Behavioral: Mind diet plus Forest Bathing
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.
No Intervention: Control group

For the control group, the participants will be received routine care.

Outcome Measures

Primary Outcome Measures

  1. Change in Blood pressure [Three months]

    By systolic blood pressure, measured by a digital automatic device

Secondary Outcome Measures

  1. Change in lipid panel of HDL cholesterol, triglycerides and LDL cholesterol [Three months]

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

  2. Change in body fat percentages [Three months]

    By body fat percentages, measured by bioelectrical impedance analysis

  3. Change in cognitive function [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 [Three months]

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

  5. Change in diet scores [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • aged 50 and above;

  • Chinese ethnicity;

  • ability to speak and understand Chinese;

  • fulfilment of the AHA criteria for stage 1 and stage 2 hypertension; and

  • physical fitness to take part in mild-intensity exercises e.g. slow walking, standing light work etc.

Exclusion Criteria:

  • poorly controlled chronic disease, including chronic obstructive pulmonary disease, cardiovascular disease, kidney disease and diabetes;

  • have allergy to more than one type of food (nuts, berries, olive oil, or fish);

  • Use of medications to treat Alzheimer's disease or Parkinson's disease;

  • pregnant;

  • participation in any dietary or relaxation programme within the past 3 months

  • experienced chronic pain and muscle weakness, and

  • were unable to walk independently.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dr. Queenie Law Hong Kong Hong Kong

Sponsors and Collaborators

  • Hong Kong Metropolitan University

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Dr Queenie Law Pui Sze, Associate Professor, Hong Kong Metropolitan University
ClinicalTrials.gov Identifier:
NCT05342896
Other Study ID Numbers:
  • HE-NHS2021/02
First Posted:
Apr 25, 2022
Last Update Posted:
Apr 25, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr Queenie Law Pui Sze, Associate Professor, Hong Kong Metropolitan University
High Blood Pressure
MIND diet
Forest Bathing
Additional relevant MeSH terms:
Hypertension

Study Results

No Results Posted as of Apr 25, 2022