UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058524 |
|---|---|
| Receipt number | R000066923 |
| Scientific Title | Tokamachi Health Prescription Trial: Applying Social Prescribing to Japan's Specific Health Guidance |
| Date of disclosure of the study information | 2025/07/19 |
| Last modified on | 2025/07/19 16:38:11 |
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Basic information
Public title
Tokamachi Health Prescription Trial: Applying Social Prescribing to Japan's Specific Health Guidance
Acronym
Tokamachi Health Prescription Trial: Applying Social Prescribing to Japan's Specific Health Guidance
Scientific Title
Tokamachi Health Prescription Trial: Applying Social Prescribing to Japan's Specific Health Guidance
Scientific Title:Acronym
Tokamachi Health Prescription Trial: Applying Social Prescribing to Japan's Specific Health Guidance
Region
| Japan |
Condition
Condition
Metabolic syndrome
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether linking participants to local providers of exercise therapy and/or nutritional counselling through social prescribing enhances the effectiveness of Japan's Specific Health Guidance at 3 months.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Withdrawal rate from Specific Health Guidance (0-3 months).
Change in waist circumference, body weight, and blood pressure from baseline to 3 months.
Key secondary outcomes
Changes in lifestyle habits before and after Specific Health Guidance
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
< 1) Control group>
Participants receive usual Specific Health Guidance only. At 3 months they attend a follow-up interview, receive a brief explanation of the study, and provide data as an opt-out control group.
Interventions/Control_2
< 2) Intervention group-1; Linked to community resources by social prescribing>
Give informed consent to be enrolled in the study after receiving a precise explanation about the study at the initial interview of the specific health guidance.
Based on an assessment by a link-worker (such as a public health nurse or a registered dietitian) about participant's lifestyle habits and social background, discuss and then select a preferred local provider offering exercise therapy and/or nutritional guidance.
Answer a prior questionnaire of the specific health guidance.
Receive a 3-month intervention by exercise therapy and/or nutritional guidance (This intervention is to be designed individually).
After the intervention, take a follow-up interview and answer a follow-up questionnaire of the specific health guidance.
Interventions/Control_3
< 3) Intervention group-2; Not linked to community resources by social prescribing>
Give informed consent to be enrolled in the study after receiving a precise explanation about the study at the initial interview of the specific health guidance.
Based on an assessment by a link-worker about participant's lifestyle habits and social background, discuss and then choose neither exercise therapy nor nutritional guidance.
Answer a prior questionnaire of the specific health guidance.
After receiving the 3-month ordinary specific health guidance, take a follow-up interview and answer a follow-up questionnaire of the specific health guidance.
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
| 40 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Control group without receiving an intervention with social prescribing;
Tokamachi resident eligible for the specific health guidance as a result of receiving Japan's specific health checkup in the 2025 fiscal year (Apr 2025 through Mar 2026) .
2) Intervention group-1 (Linked to community resources by social prescribing);
Meet the following two conditions:
<1> Tokamachi resident eligible for the specific health guidance as a result of receiving Japan's specific health checkup in the 2025 fiscal year.
<2> Agree to take exercise therapy and/or nutritional guidance at the initial interview of the specific health guidance.
3) Intervention group-2 (Not linked to community resources by social prescribing);
Meet the following two conditions:
<1> Tokamachi resident eligible for the specific health guidance as a result of receiving Japan's specific health checkup in the 2025 fiscal year.
<2> Decline to take exercise therapy and/or nutritional guidance at the initial interview of the specific health guidance.
Key exclusion criteria
Do not meet the conditions described above.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yugo |
| Middle name | |
| Last name | Shobugawa |
Organization
Niigata University
Division name
Graduate School of Medical and Dental Sciences Department of Active Ageing
Zip code
951-8510
Address
1-757 Asahimachi dori, Chuo-ku, Niigata city, Japan
TEL
025-227-2131
yugo@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Yugo |
| Middle name | |
| Last name | Shobugawa |
Organization
Niigata University
Division name
Graduate School of Medical and Dental Sciences Department of Active Ageing
Zip code
951-8510
Address
1-757 Asahimachi dori, Chuo-ku, Niigata city, Japan
TEL
025-227-2131
Homepage URL
yugo@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Hitachi,Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Niigata University
Address
1-757 Asahimachi dori, Chuo-ku, Niigata city, Japan, 951-8510
Tel
025-227-2625
ethics@adm.niigata-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
| 2025 | Year | 07 | Month | 19 | 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
| 2025 | Year | 07 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 19 | Day |
Last modified on
| 2025 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066923
