Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059951) titled 'Examination of Lifestyle Improvements for Diabetes Prevention and Enhancement of Specific Health Guidance Implementation Rates Using Individualized Health Support Apps Adapted to Diverse Lifestyles' on April 1.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Self control
Primary Sponsor:
Institute - Kyoto Prefectural University of medicine
Condition:
Condition - Health checkup examinees with BMI22 kg/m2 who are at increased risk of lifestyle-related diseases, particularly type 2 diabetes.
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the usefulness of distributing a personalized lifestyle-support smartphone application to health checkup examinees for improving the implementation rate of specific health guidance and promoting lifestyle modification for the prevention of diabetes, as well as examining its feasibility in routine practice.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - X
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - Undergoing a health check-up (specific health check-up, legally mandated health check-up, or comprehensive medical check-up).
Able to understand the study information and provide informed consent for participation via the smartphone application of their own free will.
Aged between 18 and 90 years.
Body mass index (BMI) 22 kg/m.
Owning a smartphone on which the study application can be installed and used.
Key exclusion criteria - Women who are pregnant or may be pregnant.
Individuals with diabetes, renal disease or other conditions who require medically supervised dietary therapy.
Body mass index (BMI) < 22 kg/m.
Deemed inappropriate for study participation by the attending physician or principal investigator.
Target Size - 2200
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 06 Month 13 Day
Date of IRB - 2025 Year 06 Month 13 Day
Anticipated trial start date - 2026 Year 04 Month 01 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068574
Disclaimer: Curated by HT Syndication.