UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062506 |
|---|---|
| Receipt number | R000071556 |
| Scientific Title | Effects of Agricultural Activities and Community Interaction on Physical and Mental Vitality in Hidaka Village, Kochi: An Empirical Study Using Wearable Devices and Multimodal Biomarkers |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/08/07 13:31:54 |
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Basic information
Public title
A Study on Enhancing Physical and Mental Vitality through Agricultural Activities and Community Interaction in Hidaka Village, Kochi
Acronym
HARVEST Study
Scientific Title
Effects of Agricultural Activities and Community Interaction on Physical and Mental Vitality in Hidaka Village, Kochi: An Empirical Study Using Wearable Devices and Multimodal Biomarkers
Scientific Title:Acronym
HARVEST Study:
Hidaka Agricultural and Regional Vitality Evaluation through Social Interaction and Wearable Technologies
Region
| Japan |
Condition
Condition
As the subjects are healthy adults, no specific disease name applies.
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To objectively and quantitatively evaluate the impact of agricultural activities and community interactions on the physical and mental vitality of older adults in Hidaka Village, Kochi Prefecture, and visitors from urban areas, and to construct and verify a new 'Vitality Index.' Furthermore, to examine the effectiveness of utilizing this data in developing a 'daily monitoring system' to support the enhancement of older adults' well-being.
Basic objectives2
Others
Basic objectives -Others
This study evaluates how agricultural activities and community interactions impact the vitality of older adults in Hidaka Village, Kochi, and urban visitors.
We will construct a "Vitality Index" by integrating wearable vital data (heart rate, HRV), biometric and behavioral metrics (facial expressions, pupillary diameter, voice), and daily subjective evaluations via LINE. By comparing periods with and without agricultural work, we will clarify how these indicators relate to subjective health and autonomic nervous system activity.
Additionally, this data can enable "routine monitoring" to detect daily health changes, facilitating timely support from families and the community. We will examine the data's effectiveness in developing a monitoring system that enhances older adults' well-being.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in participants' 'vitality levels' (physical and mental vitality) before and after routine agricultural activities, event participation, and short-term agricultural interventions, as well as the correlations among various indicators (subjective questionnaire scores, step counts, heart rate variability, sleep status, pupillary light reflex and pupillary diameter, voice data, and facial expression data).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
We will compare the health status and autonomic nervous system activity between regular agricultural workers and office workers (non-agricultural workers, such as municipal employees) residing in Hidaka Village, Kochi Prefecture.
Interventions/Control_2
For event visitors from urban areas (e.g., young adults), a single-arm pre-post comparison and a comparison of longitudinal changes within the same subjects will be conducted.
Interventions/Control_3
Agricultural work and interactions with local residents will be defined as a "short-term intervention," and the physiological and psychological changes (e.g., physical and mental refreshment and stress reduction effects) before and after this intervention will be compared and evaluated.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals who are regular agricultural workers or office workers residing in Hidaka Village, Kochi Prefecture, or visitors from urban and other areas participating in agricultural support events in Hidaka Village.
Aged 18 years or older at the time of obtaining informed consent.
Individuals who have provided voluntary writtenconsent to participate in the study after receiving a sufficient explanation and fully understanding its purpose and methods.
Key exclusion criteria
Individuals who have difficulty wearing a smartwatch continuously (e.g., due to skin rashes or allergies).
Individuals with severe physical or psychiatric disorders for whom participation in the study is judged to be an undue burden.
Individuals who have difficulty understanding the contents of the informed consent due to cognitive decline or other conditions.
Other individuals deemed inappropriate for participation in this study by the principal investigator or co-investigators.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Atsue |
| Middle name | |
| Last name | Ishii |
Organization
The University of Osaka Graduate School of Medicine
Division name
Division of Health Science
Zip code
565-0871
Address
1-7 Yamadaoka, Suita City, Osaka Prefecture
TEL
06-6879-2521
atsue@sahs.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | HIroshi |
| Middle name | |
| Last name | Maruyama |
Organization
Panasonic Holdings Corporation
Division name
Product Analysis Center
Zip code
571-8508
Address
1006 Oaza Kadoma, Kadoma, Osaka
TEL
080-8506-4401
Homepage URL
maruyama.h@jp.panasonic.com
Sponsor or person
Institute
The University of Osaka
Institute
Department
Personal name
Funding Source
Organization
The University of Osaka
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Hospital Institutional Review Board
Address
2-2 Yamadaoka, Suita City, Osaka Prefecture
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 07 | Day |
Last modified on
| 2026 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071556
