search
Back to results

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

Primary Purpose

High Blood Pressure

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
MIND diet
Mind diet plus Forest Bathing
Sponsored by
Hong Kong Metropolitan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for High Blood Pressure focused on measuring High Blood Pressure, MIND diet, Forest Bathing

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dr. Queenie LawRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

MIND diet intervention

MIND-plus-FB intervention

Control group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Change in Blood pressure
By systolic blood pressure, measured by a digital automatic device

Secondary Outcome Measures

Change in lipid panel of HDL cholesterol, triglycerides and LDL cholesterol
By point of care test (POCT) of lipid panel (HDL-cholesterol, triglycerides and LDL-cholesterol)
Change in body fat percentages
By body fat percentages, measured by bioelectrical impedance analysis
Change in cognitive function
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.
Change in waist circumference
By waist circumference, measured by tape meter between the lower rib and iliac crest
Change in diet scores
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.

Full Information

First Posted
December 6, 2021
Last Updated
March 1, 2023
Sponsor
Hong Kong Metropolitan University
search

1. Study Identification

Unique Protocol Identification Number
NCT05342896
Brief Title
Effect of Mediterranean-DASH Intervention for Neurodegenerative Delay Plus Forest Bathing
Acronym
MINDdiet
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 3, 2021 (Actual)
Primary Completion Date
July 30, 2022 (Actual)
Study Completion Date
March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hong Kong Metropolitan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Blood Pressure
Keywords
High Blood Pressure, MIND diet, Forest Bathing

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
It will be a single-blind trial; only the assessors will be blinded to the treatment assignment.
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MIND diet intervention
Arm Type
Experimental
Arm Description
3-month intervention of dietary counseling to adhere to the MIND diet
Arm Title
MIND-plus-FB intervention
Arm Type
Experimental
Arm Description
3-month intervention of dietary counseling to adhere to the MIND diet plus Forest Bathing intervention
Arm Title
Control group
Arm Type
No Intervention
Arm Description
For the control group, the participants will be received routine care.
Intervention Type
Behavioral
Intervention Name(s)
MIND diet
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mind diet plus Forest Bathing
Intervention Description
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 Outcome Measure Information:
Title
Change in Blood pressure
Description
By systolic blood pressure, measured by a digital automatic device
Time Frame
Three months
Secondary Outcome Measure Information:
Title
Change in lipid panel of HDL cholesterol, triglycerides and LDL cholesterol
Description
By point of care test (POCT) of lipid panel (HDL-cholesterol, triglycerides and LDL-cholesterol)
Time Frame
Three months
Title
Change in body fat percentages
Description
By body fat percentages, measured by bioelectrical impedance analysis
Time Frame
Three months
Title
Change in cognitive function
Description
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.
Time Frame
Three months
Title
Change in waist circumference
Description
By waist circumference, measured by tape meter between the lower rib and iliac crest
Time Frame
Three months
Title
Change in diet scores
Description
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.
Time Frame
Three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Queenie Law, PhD
Phone
39702974
Email
qlaw@hkmu.edu.hk
Facility Information:
Facility Name
Dr. Queenie Law
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Queenie Law, PhD
Phone
39702974
Email
qlaw@hkmu.edu.hk

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Will be shared by completion of data
IPD Sharing Time Frame
June 2022
IPD Sharing Access Criteria
Pilot result will be published in journal article
Citations:
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs