Tokyo, July 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058524) titled 'Tokamachi Health Prescription Trial: Applying Social Prescribing to Japan's Specific Health Guidance' on July 19.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Niigata University
Condition:
Condition - Metabolic syndrome
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
Interventions/Control_1 -
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 -
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.
Eligibility:
Age-lower limit - 40
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:
Tokamachi resident eligible for the specific health guidance as a result of receiving Japan's specific health checkup in the 2025 fiscal year.
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:
Tokamachi resident eligible for the specific health guidance as a result of receiving Japan's specific health checkup in the 2025 fiscal year.
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 Size - 200
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 07 Month 18 Day
Anticipated trial start date - 2025 Year 09 Month 18 Day
Last follow-up date - 2025 Year 12 Month 18 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066923
Disclaimer: Curated by HT Syndication.
