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

NCT05342896 | Completed

• 1 other identifier: HE-NHS2021/02
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

High Blood Pressure

Keywords

High Blood Pressure; MIND diet; Forest Bathing

Outcome Measures

Primary Outcomes (1)

• Change in Blood pressure

  By systolic blood pressure, measured by a digital automatic device

  Three months

Secondary Outcomes (5)

• 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

Study Arms (3)

MIND diet intervention

EXPERIMENTAL

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

Behavioral: MIND diet

MIND-plus-FB intervention

EXPERIMENTAL

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

Behavioral: Mind diet plus Forest Bathing

Control group

NO INTERVENTION

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

Interventions

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 intervention

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.

MIND-plus-FB intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hong Kong Metropolitan University: lead

Study Sites (1)

Dr. Queenie Law

Hong Kong, Hong Kong

Location

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

Forest Therapy

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Relaxation Therapy; Mind-Body Therapies; Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: It will be a single-blind trial; only the assessors will be blinded to the treatment assignment.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: April 25, 2022
• Study Start: January 3, 2021
• Primary Completion: July 30, 2022
• Study Completion: March 31, 2023
• Last Updated: November 3, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: June 2022
• Access Criteria: Pilot result will be published in journal article

Locations

HK (1)