NCT06351423

Brief Summary

This clinical trial aims to explore the effectiveness of the Mediterranean DASH Intervention for Neurodegenerative Delay (MIND) diet and Forest Bathing (FB) in reducing psychological stress among older Chinese individuals. The main questions it aims to answer are:

  1. 1.what is the effect of FB on stress reduction
  2. 2.what is the effect of MIND on stress reduction
  3. 3.FB: a two-hour FB session on four consecutive weekends in a country park,
  4. 4.MIND: four nutrition sessions, and adhere to the MIND diet for 12 weeks

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 8, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

July 3, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

July 3, 2024

Status Verified

February 1, 2024

Enrollment Period

2 months

First QC Date

April 2, 2024

Last Update Submit

July 2, 2024

Conditions

Keywords

MIND dietMediterranean-DASH Intervention for Neurodegenerative DelayFBForest Bathing

Outcome Measures

Primary Outcomes (1)

  • Emotional states

    Emotional states are measured using self-reported Chinese questionaries of depression, anxiety and stress scale -21 items (DASS-21) with alpha coefficient ranging from 0.79 to 0.83 (Cao et al., 2023).

    The outcome measures will be evaluated at three time points: baseline assessment (T0), immediately after the fourth session (T1), and 12 weeks following the intervention (T2) at the participating community center.

Secondary Outcomes (2)

  • Systolic Blood Pressure (SBP)

    The outcome measures will be evaluated at three time points: baseline assessment (T0), immediately after the fourth session (T1), and 12 weeks following the intervention (T2) at the participating community center.

  • Salivary Cortisol

    The outcome measures will be evaluated at three time points: baseline assessment (T0), immediately after the fourth session (T1), and 12 weeks following the intervention (T2) at the participating community center.

Study Arms (3)

MIND Diet and Forest Bathing (MIND-FB)

EXPERIMENTAL

In this arm, participants will receive both the MIND diet and Forest Bathing (FB) intervention.

Behavioral: Forest Bathing (FB)Behavioral: MIND diet

Forest bathing (FB)

ACTIVE COMPARATOR

In this arm, participants will receive Forest Bathing intervention only.

Behavioral: Forest Bathing (FB)

routine care group

NO INTERVENTION

The routine care group will be instructed to perform daily activities as usual and will receive a health talk and be given pamphlets about tips on maintaining mental well-being.

Interventions

The forest bathing (FB) intervention will be comprised of four 2-hour sessions held in a country park on four consecutive weekends during the daytime. The FB sessions will cover 1-2 kilometers per forest visit. Participants will convene at the country park entrance. An FB guide will provide a briefing and commence the forest trip. Following 20 minutes for participants to slow down and share their experiences, they will be invited to mindfully center themselves using their five senses for another 20 minutes. Subsequently, the participants will be afforded 20 minutes to wander along a designated forest path, followed by another 20 minutes during which they will be encouraged to stroll in a designated area to help foster a deep connection with the forest. Participants will have a 20-minute interval between each activity to share their experiences. A tea ceremony will be held at the end of each FB session.

Forest bathing (FB)MIND Diet and Forest Bathing (MIND-FB)
MIND dietBEHAVIORAL

The participants will undertake four three-month nutrition programmes consisting of four nutrition counselling sessions in an activity room at each participating community centre. All intervention sessions will be conducted by a registered nutritionist. In the nutrition sessions, the participants will learn to modify their diet to meet the MIND diet guidelines. The MIND diet promotes 10 healthy food groups and limits five unhealthy food groups (Morris et al., 2015a; Arjmand et al., 2022). As a reference, a 7-day sample menu will be provided which meets the required number of servings per day.

MIND Diet and Forest Bathing (MIND-FB)

Eligibility Criteria

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

You may qualify if:

  • Chinese ethnicity, and
  • able to speak and understand Cantonese, and
  • the Chinese version of the DASS-21 stress subscale score larger than or equal to 8, and smaller than or equal to 12; or
  • the Chinese version of the DASS-21 anxiety subscale score larger than or equal to 4, and smaller than or equal to 7, or
  • the Chinese version of the DASS-21 depression subscale score larger than or equal to 5, and smaller than or equal to 10.

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
  • known to mental health services
  • those who participated in any relaxation or dietary programme in the past 3 months and those who anticipate joining such a programme shortly
  • those who are unable to walk independently

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong Kong Metropolitan University

Hong Kong, Hong Kong

RECRUITING

Related Publications (6)

  • 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
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    BACKGROUND
  • Lee I, Choi H, Bang KS, Kim S, Song M, Lee B. Effects of Forest Therapy on Depressive Symptoms among Adults: A Systematic Review. Int J Environ Res Public Health. 2017 Mar 20;14(3):321. doi: 10.3390/ijerph14030321.

    PMID: 28335541BACKGROUND
  • Fresan U, Bes-Rastrollo M, Segovia-Siapco G, Sanchez-Villegas A, Lahortiga F, de la Rosa PA, Martinez-Gonzalez MA. Does the MIND diet decrease depression risk? A comparison with Mediterranean diet in the SUN cohort. Eur J Nutr. 2019 Apr;58(3):1271-1282. doi: 10.1007/s00394-018-1653-x. Epub 2018 Mar 7.

    PMID: 29516224BACKGROUND
  • Cherian L, Wang Y, Holland T, Agarwal P, Aggarwal N, Morris MC. DASH and Mediterranean-Dash Intervention for Neurodegenerative Delay (MIND) Diets Are Associated With Fewer Depressive Symptoms Over Time. J Gerontol A Biol Sci Med Sci. 2021 Jan 1;76(1):151-156. doi: 10.1093/gerona/glaa044.

    PMID: 32080745BACKGROUND
  • Barkhordari R, Namayandeh M, Mirzaei M, Sohouli MH, Hosseinzadeh M. The relation between MIND diet with psychological disorders and psychological stress among Iranian adults. BMC Psychiatry. 2022 Jul 25;22(1):496. doi: 10.1186/s12888-022-04128-2.

    PMID: 35879688BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersDepressionStress, Psychological

Interventions

Forest Therapy

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Relaxation TherapyMind-Body TherapiesComplementary TherapiesTherapeutics

Study Officials

  • Fabian Ling Ngai Tung, PhD

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabian Ling Ngai Tung, PhD

CONTACT

Queenie Pui Sze Law, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: a 3-arm randomized controlled study in a parallel design. Eligible participants will be randomly assigned into 3 interventions: (1) FB-MIND, (2) FB and (3) routine care-control.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2024

First Posted

April 8, 2024

Study Start

July 3, 2024

Primary Completion

August 31, 2024

Study Completion

November 30, 2024

Last Updated

July 3, 2024

Record last verified: 2024-02

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
6 months after publication.
Access Criteria
Investigators whose proposed research has received approval from the Institutional Review Boards (IRB).

Locations