Tokyo, May 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061533) titled 'Effective Implementation of The Evidence-Based Specific Health Guidance' on May 12.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Non-randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Institute of Science Tokyo

Condition: Condition - Lifestyle-related diseases Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Evidence-based development of an integrated health guidance program (Well Smart) utilizing ICT and tailored for individuals in their 40s, integrating multidimensional big data analysis and qualitative research, and its effectiveness verification through an open-label two-group comparative intervention trial Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - The intervention group will receive a three-month health guidance program using ICT, along with questionnaire surveys and measurements of weight, waist circumference, and urinary natriuretic peptide ratio at baseline, midpoint, and completion. Blood samples will also be collected at baseline and completion. Interventions/Control_2 - The control group will not receive the program. Questionnaires, weight measurements, waist circumference measurements, urine natriuretic peptide ratio measurements, and blood draws will be conducted twice: before the intervention begins and after it ends.

Eligibility: Age-lower limit - 40 years-old = Gender - Male and Female Key inclusion criteria - 1) Employees who are 40 years of age or older and 65 years of age or younger at the time of obtaining consent. 2) Individuals capable of independently performing the operations and wearing the ICT devices required for the study. 3) BMI of 25 or higher 4) Individuals who, based on their health examination results, meet at least one of the following risk factors for metabolic syndrome: Hypertension: Systolic blood pressure (maximum) of 130 mmHg or higher, or diastolic blood pressure (minimum) of 85 mmHg or higher, or taking antihypertensive medication Dyslipidemia: Triglycerides of 150 mg/dL or higher, or HDL cholesterol below 40 mg/dL, or taking lipid-lowering medication Hyperglycemia: Fasting blood glucose of 110 mg/dL or higher, or HbA1c of 6.0% or higher, or currently taking medication for diabetes 5) Individuals capable of undergoing and participating in physical measurements and fitness tests 6) Individuals who have provided informed consent to participate in the study 7) Individuals who have been approved to participate by their attending physician or other medical professional Key exclusion criteria - Individuals who are pregnant or breastfeeding, those with severe liver or kidney dysfunction, and those who have been hospitalized or undergone surgery for an orthopedic condition within the past three months are excluded. In addition, individuals deemed unsuitable by the principal investigator or co-investigators will also be excluded. Target Size - 50

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 01 Day Anticipated trial start date - 2026 Year 08 Month 01 Day Last follow-up date - 2027 Year 04 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069672

Disclaimer: Curated by HT Syndication.