NCT06222632

Brief Summary

This randomized controlled trial aims to study the effects of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet combined with forest bathing (FB) on reducing cardiovascular disease (CVD) risk factors in Chinese adults aged 50-75 years at increased risk of CVDs. The study will assess the impact of the intervention on obesity, higher cholesterol, higher blood pressure, higher triglycerides and glucose levels, stress, and negative emotional state. The investigators hypothesize that the MIND diet combined with FB will have increased cardiac and mental health benefits in Chinese adults with elevated LDL-C compared to the MIND diet alone and routine care. The main questions it aims to answer are:

  • What are the effects of the MIND diet plus FB, the MIND diet alone, and routine care on various cardiovascular risk factors and mental health indicators at 4 weeks?
  • What is the sustained effect of the MIND diet plus FB, the MIND diet alone, and routine care on these cardiovascular risk factors at 12 weeks?
  • How do the effects of the MIND diet plus FB, the MIND diet alone, and routine care differ when considering other individual characteristics such as demographic and lifestyle factors? This twelve-week study will involve screening participants, obtaining their consent, and measuring various parameters such as blood pressure, lipid panel, glucose levels, waist circumference, body mass index, and dietary intake. Participants will also complete two psychometric questionnaires. Measurements will be taken at three time points: before the intervention, immediately after four weeks of intervention, and at the end of the twelve-week intervention period. Each measurement session is expected to last around 20 minutes. Participants assigned to the MIND group will attend nutrition group counseling classes and adopt the MIND diet for twelve weeks. Participants in the MIND plus FB group will attend nutrition group counseling classes and participate in forest bathing sessions. Participants in the routine-care group will continue their usual activities and receive health talks and pamphlets about cardiovascular diseases. The investigators will examine and compare the effects of the interventions on cardiovascular risk factors and mental health at 4 weeks and 12 weeks to determine if there are combined and sustained effects.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
273

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Mar 2024Feb 2027

First Submitted

Initial submission to the registry

December 26, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

3 years

First QC Date

December 26, 2023

Last Update Submit

March 25, 2024

Conditions

Keywords

MIND dietForest bathingLDL cholesterolmoodanxietyglucoseTriglycerides

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in the mean Low-density lipoprotein cholesterol (LDL-C) at 12 week

    The investigators will measure total cholesterol, LDL-C, HDL-C, triglycerides and glucose with the CardioChek Professional Analyser (PA), Point of Care Test (POCT), which has been certified by the United States Food and Drug Administration and by the Centers for Disease Control and Prevention, Cholesterol Reference Method Laboratory Network. The participants will need to fast for 6-8 hours before the POCT.

    From Baseline to 12 weeks.

Secondary Outcomes (10)

  • Change from baseline in the mean Low-density lipoprotein cholesterol (LDL-C) at 4 weeks

    From Baseline to 4 weeks.

  • Change from baseline in the mean High-density lipoprotein cholesterol (HDL-C) at 4 & 12 weeks

    From Baseline to 4 & 12 weeks.

  • Change from baseline in the mean triglycerides at 4 & 12 week

    From Baseline to 4 & 12 weeks.

  • Change from baseline in the mean glucose at 4 & 12 week

    From Baseline to 4 & 12 weeks.

  • Change from baseline in the mean total cholesterol at 4 & 12 week

    From Baseline to 4 & 12 weeks.

  • +5 more secondary outcomes

Other Outcomes (1)

  • Change from baseline in the mean MIND diet score at 4 & 12 week

    From Baseline to 4 & 12 weeks.

Study Arms (3)

MIND diet

EXPERIMENTAL

The MIND group will consume the MIND diet for 12 weeks.

Other: Mind diet intervention

MIND plus FB

EXPERIMENTAL

The MIND plus FB intervention will consist of eight sessions.

Other: Mind plus FB intervention

Usual Care

OTHER

The routine care group will be instructed to perform daily activities as usual

Other: Usual care

Interventions

These participants will receive four nutrition information sessions, 60 minutes per session, on four consecutive weekdays at the participating community centre. A 7-day sample menu will be developed and explained to the participants as a reference. A nutritionist with the help of a research assistant will conduct each session. The nutritionist-to-participant ratio for each session will be 1:10, 1:11 or 1:12. The following topics will be covered: (1) overview of the MIND diet; (2) discussion with the participants about their ability, motivation and opportunity to adopt the MIND diet; and (3) instruction on how to adopt the MIND diet and how to fill out a logbook for adherence checks.

MIND diet

The sessions will include four nutritional sessions about the MIND diet and four FB sessions. The participants will be instructed on the MIND diet as previously mentioned. In addition, the MIND-FB participants will undertake four 2 h FB sessions in a country park on four consecutive weekends during daytime hours. The FB sessions will take place during the day if it is sunny, cloudy or lightly raining. The distance covered on each forest visit will be 1-2 kilometres. If it is raining heavily, the session will be cancelled. The participants will gather at the entrance of the country park on the day of FB. The participants will gather at the entrance of the country park on the day of FB. An FB coach will brief the participants and begin the forest trip with a set of experiences on the forest environment. The participants will also be instructed to self-practice FB for 2h per session at weeks 8 \& 12 of the intervention.

MIND plus FB

Participants will receive a health talk and be given pamphlets provided by the Department of Health and/or Hospital Authority about the protective factors and risk factors of CVDs.

Usual Care

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 50-75 years;
  • Chinese ethnicity;
  • able to speak and understand Cantonese;
  • LDL-C point-of-care test (POCT) \>2.6 mmol/L;
  • State and Trait Anxiety Inventory (STAI) score ≧38;
  • physically able to participate in mild-intensity exercise

You may not qualify if:

  • kidney disease and chronic obstructive pulmonary disease that is poorly controlled,
  • known allergies to berries, nuts, fish or olive oil,
  • diagnosed mental disorder with medication,
  • pregnant,
  • those who participated in any relaxation or dietary programme in the past 3 months and those who anticipate joining such a programme in the near future
  • those who are unable to walk independently,
  • those SBP is more than 159 mmHg.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

16/F, Ma Kam Chan Memorial Building, 31 Wylie Road, Homantin,

Hong Kong, Hong Kong

Location

Related Publications (20)

  • Aminianfar A, Hassanzadeh Keshteli A, Esmaillzadeh A, Adibi P. Association between adherence to MIND diet and general and abdominal obesity: a cross-sectional study. Nutr J. 2020 Feb 17;19(1):15. doi: 10.1186/s12937-020-00531-1.

    PMID: 32066452BACKGROUND
  • Arnett DK, Blumenthal RS, Albert MA, Buroker AB, Goldberger ZD, Hahn EJ, Himmelfarb CD, Khera A, Lloyd-Jones D, McEvoy JW, Michos ED, Miedema MD, Munoz D, Smith SC Jr, Virani SS, Williams KA Sr, Yeboah J, Ziaeian B. 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Sep 10;140(11):e596-e646. doi: 10.1161/CIR.0000000000000678. Epub 2019 Mar 17. No abstract available.

    PMID: 30879355BACKGROUND
  • Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, Braun LT, de Ferranti S, Faiella-Tommasino J, Forman DE, Goldberg R, Heidenreich PA, Hlatky MA, Jones DW, Lloyd-Jones D, Lopez-Pajares N, Ndumele CE, Orringer CE, Peralta CA, Saseen JJ, Smith SC Jr, Sperling L, Virani SS, Yeboah J. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019 Jun 25;73(24):e285-e350. doi: 10.1016/j.jacc.2018.11.003. Epub 2018 Nov 10. No abstract available.

    PMID: 30423393BACKGROUND
  • Katsarou AL, Vryonis MM, Protogerou AD, Alexopoulos EC, Achimastos A, Papadogiannis D, Chrousos GP, Darviri C. Stress management and dietary counseling in hypertensive patients: a pilot study of additional effect. Prim Health Care Res Dev. 2014 Jan;15(1):38-45. doi: 10.1017/S1463423612000679. Epub 2013 Feb 21.

    PMID: 23425517BACKGROUND
  • Malekmohammad K, Bezsonov EE, Rafieian-Kopaei M. Role of Lipid Accumulation and Inflammation in Atherosclerosis: Focus on Molecular and Cellular Mechanisms. Front Cardiovasc Med. 2021 Sep 6;8:707529. doi: 10.3389/fcvm.2021.707529. eCollection 2021.

    PMID: 34552965BACKGROUND
  • Mortensen MB, Nordestgaard BG. Elevated LDL cholesterol and increased risk of myocardial infarction and atherosclerotic cardiovascular disease in individuals aged 70-100 years: a contemporary primary prevention cohort. Lancet. 2020 Nov 21;396(10263):1644-1652. doi: 10.1016/S0140-6736(20)32233-9. Epub 2020 Nov 10.

    PMID: 33186534BACKGROUND
  • Morera LP, Marchiori GN, Medrano LA, Defago MD. Stress, Dietary Patterns and Cardiovascular Disease: A Mini-Review. Front Neurosci. 2019 Nov 12;13:1226. doi: 10.3389/fnins.2019.01226. eCollection 2019.

    PMID: 31780892BACKGROUND
  • Morris MC, Tangney CC, Wang Y, Sacks FM, Bennett DA, Aggarwal NT. MIND diet associated with reduced incidence of Alzheimer's disease. Alzheimers Dement. 2015 Sep;11(9):1007-14. doi: 10.1016/j.jalz.2014.11.009. Epub 2015 Feb 11.

    PMID: 25681666BACKGROUND
  • Morris MC, Tangney CC, Wang Y, Sacks FM, Barnes LL, Bennett DA, Aggarwal NT. MIND diet slows cognitive decline with aging. Alzheimers Dement. 2015 Sep;11(9):1015-22. doi: 10.1016/j.jalz.2015.04.011. Epub 2015 Jun 15.

    PMID: 26086182BACKGROUND
  • Roth GA, Mensah GA, Johnson CO, Addolorato G, Ammirati E, Baddour LM, Barengo NC, Beaton AZ, Benjamin EJ, Benziger CP, Bonny A, Brauer M, Brodmann M, Cahill TJ, Carapetis J, Catapano AL, Chugh SS, Cooper LT, Coresh J, Criqui M, DeCleene N, Eagle KA, Emmons-Bell S, Feigin VL, Fernandez-Sola J, Fowkes G, Gakidou E, Grundy SM, He FJ, Howard G, Hu F, Inker L, Karthikeyan G, Kassebaum N, Koroshetz W, Lavie C, Lloyd-Jones D, Lu HS, Mirijello A, Temesgen AM, Mokdad A, Moran AE, Muntner P, Narula J, Neal B, Ntsekhe M, Moraes de Oliveira G, Otto C, Owolabi M, Pratt M, Rajagopalan S, Reitsma M, Ribeiro ALP, Rigotti N, Rodgers A, Sable C, Shakil S, Sliwa-Hahnle K, Stark B, Sundstrom J, Timpel P, Tleyjeh IM, Valgimigli M, Vos T, Whelton PK, Yacoub M, Zuhlke L, Murray C, Fuster V; GBD-NHLBI-JACC Global Burden of Cardiovascular Diseases Writing Group. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol. 2020 Dec 22;76(25):2982-3021. doi: 10.1016/j.jacc.2020.11.010.

    PMID: 33309175BACKGROUND
  • Szczepanska E, Bialek-Dratwa A, Janota B, Kowalski O. Dietary Therapy in Prevention of Cardiovascular Disease (CVD)-Tradition or Modernity? A Review of the Latest Approaches to Nutrition in CVD. Nutrients. 2022 Jun 27;14(13):2649. doi: 10.3390/nu14132649.

    PMID: 35807830BACKGROUND
  • Yau KK, Loke AY. Effects of forest bathing on pre-hypertensive and hypertensive adults: a review of the literature. Environ Health Prev Med. 2020 Jun 22;25(1):23. doi: 10.1186/s12199-020-00856-7.

    PMID: 32571202BACKGROUND
  • Yau KY, Law PS, Wong CN. Cardiac and Mental Benefits of Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet plus Forest Bathing (FB) versus MIND Diet among Older Chinese Adults: A Randomized Controlled Pilot Study. Int J Environ Res Public Health. 2022 Nov 8;19(22):14665. doi: 10.3390/ijerph192214665.

    PMID: 36429384BACKGROUND
  • Vale S. Psychosocial stress and cardiovascular diseases. Postgrad Med J. 2005 Jul;81(957):429-35. doi: 10.1136/pgmj.2004.028977.

    PMID: 15998817BACKGROUND
  • Shek DT. The Chinese version of the State-Trait Anxiety Inventory: its relationship to different measures of psychological well-being. J Clin Psychol. 1993 May;49(3):349-58. doi: 10.1002/1097-4679(199305)49:33.0.co;2-j.

    PMID: 8315037BACKGROUND
  • Chen KM, Snyder M, Krichbaum K. Translation and equivalence: the Profile of Mood States Short Form in English and Chinese. Int J Nurs Stud. 2002 Aug;39(6):619-24. doi: 10.1016/s0020-7489(01)00068-2.

    PMID: 12100873BACKGROUND
  • Bolodeoku J, Pinkney S (2019) Imprecision Evaluation of Self-Monitoring of Blood Cholesterol (SMBC) Handheld Point of Care Testing Devices: Elemark™ and Cardiochek PA. Ann Clin Lab Res Vol.7 No.1:290. doi: 10.21767/2386-5180.100290

    BACKGROUND
  • Topouchian J, Agnoletti D, Blacher J, Youssef A, Chahine MN, Ibanez I, Assemani N, Asmar R. Validation of four devices: Omron M6 Comfort, Omron HEM-7420, Withings BP-800, and Polygreen KP-7670 for home blood pressure measurement according to the European Society of Hypertension International Protocol. Vasc Health Risk Manag. 2014 Jan 16;10:33-44. doi: 10.2147/VHRM.S53968. eCollection 2014.

    PMID: 24476688BACKGROUND
  • Chen, K. (2000). The Effects of Tai Chi on the Well-being of Community -dwelling Elders in Taiwan, ProQuest Dissertations and Theses. https://ddc-elib-comtw.ezproxy.lb.polyu.edu.hk/doc/9962998

    BACKGROUND
  • Law PSQ, Yau KY, Wong DC, Yuen KS, Yu CP, Loke AY. Cardioprotective and mentally protective effects of the Mediterranean-dietary approaches to stop hypertension intervention for neurodegenerative delay diet combined with forest bathing among adults with elevated blood cholesterol: a parallel group randomised controlled study protocol. BMJ Open. 2025 Sep 2;15(9):e107982. doi: 10.1136/bmjopen-2025-107982.

Related Links

MeSH Terms

Conditions

Hyperlipoproteinemia Type IIAnxiety Disorders

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipoproteinemiasHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesMental Disorders

Study Officials

  • Dr. Katherine Yau, Doctoral

    Tung Wah College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 26, 2023

First Posted

January 25, 2024

Study Start

March 1, 2024

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 28, 2027

Last Updated

March 26, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

I would share all individual participant data (IPD) that underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
starting 6 months after publication
Access Criteria
investigators whose proposed research has received Institutional Review Boards (IRB) approval

Locations