High Blood PressureMINDdietNCT05342896
Effect of Mediterranean-DASH Intervention for Neurodegenerative Delay Plus Forest Bathing
A study testing MIND diet and Mind diet plus Forest Bathing in people with High Blood Pressure, run by Hong Kong Metropolitan University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- High Blood Pressure
- What is being tested?
- MIND diet and Mind diet plus Forest Bathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteHong Kong
- Study dates
- 3 Jan 2021to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- High Blood Pressure
- Being tested
- MIND diet, Mind diet plus Forest Bathing
- Keywords
- High Blood Pressure, MIND diet, Forest Bathing
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIND dietBehavioural
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 BathingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MIND diet intervention | Experimental | 3-month intervention of dietary counseling to adhere to the MIND diet Receives: Behavioral: MIND diet |
| MIND-plus-FB intervention | Experimental | 3-month intervention of dietary counseling to adhere to the MIND diet plus Forest Bathing intervention Receives: Behavioral: Mind diet plus Forest Bathing |
| Control group | No intervention | For the control group, the participants will be received routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Blood pressure
By systolic blood pressure, measured by a digital automatic device
Measured: Three months
Secondary outcomes (5)
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)
Measured: Three months
Change in body fat percentages
By body fat percentages, measured by bioelectrical impedance analysis
Measured: Three months
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.
Measured: Three months
Change in waist circumference
By waist circumference, measured by tape meter between the lower rib and iliac crest
Measured: Three months
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.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start3 Jan 2021
- Primary completion30 Jul 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for High Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hong Kong Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Queenie Law Pui Sze, Hong Kong Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342896
- Sponsor's protocol ID
- HE-NHS2021/02
- Acronym
- MINDdiet
- Status last verified
- Nov 2023
- First submitted
- 6 Dec 2021
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will be shared by completion of data
Publications
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.
Law QPS, Yau KKY, Tyrovolas S, Kwan RYC. Effects of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet and forest bathing in improving cognitive and metabolic health among hypertensive older adults: a feasibility randomised controlled trial. BMC Nutr. 2026 Jan 10;12(1):27. doi: 10.1186/s40795-026-01240-4.
PubMed 41514353
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05342896
- Acronym / sponsor ID
- MINDdiet / HE-NHS2021/02
- Conditions
- High Blood Pressure
- Keywords
- High Blood Pressure, MIND diet, Forest Bathing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hong Kong Metropolitan UniversityUniversity, hospital or other
- Study start
- 3 Jan 2021 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MIND diet intervention | Experimental | Behavioral: MIND diet3-month intervention of dietary counseling to adhere to the MIND diet |
| MIND-plus-FB intervention | Experimental | Behavioral: Mind diet plus Forest Bathing3-month intervention of dietary counseling to adhere to the MIND diet plus Forest Bathing intervention |
| Control group | No intervention | –For the control group, the participants will be received routine care. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIND dietMIND 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. | Behavioural | MIND diet intervention |
| Mind diet plus Forest BathingMIND 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. | Behavioural | MIND-plus-FB intervention |
Primary outcome
Change in Blood pressure
Time frame: Three months
By systolic blood pressure, measured by a digital automatic device
5 secondary outcomes
Change in lipid panel of HDL cholesterol, triglycerides and LDL cholesterol
Time frame: Three months
Change in body fat percentages
Time frame: Three months
Change in cognitive function
Time frame: Three months
Change in waist circumference
Time frame: Three months
Change in diet scores
Time frame: Three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
- Background1. 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.
- Derived from this study: PubMed 41514353Law QPS, Yau KKY, Tyrovolas S, Kwan RYC. Effects of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet and forest bathing in improving cognitive and metabolic health among hypertensive older adults: a feasibility randomised controlled trial. BMC Nutr. 2026 Jan 10;12(1):27. doi: 10.1186/s40795-026-01240-4.
- Individual participant dataSharing planned: Yes. Will be shared by completion of data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIND diet and Mind diet plus Forest Bathing in people with High Blood Pressure, run by Hong Kong Metropolitan University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Blood pressure (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05342896, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2023.