Tokyo, Sept. 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059026) titled 'Effectiveness of Digital Health Services in Preventing Lifestyle-Related Diseases' on Sept. 8.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Kyushu University
Condition:
Condition - Non-communicable diseases
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to evaluate the effectiveness of digital health services in preventing lifestyle-related diseases by using digital devices such as smartwatches and smartphone apps.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - AI feedback is delivered daily via the smartphone app.
Interventions/Control_2 - AI feedback is delivered weekly via the smartphone app.
Eligibility:
Age-lower limit - 40
years-old
=
Gender - Male and Female
Key inclusion criteria - Eligible participants shall be individuals who have provided consent, selected from among those targeted by the "Specific Health Guidance (Active Support and Motivational Support)" and the "Disease Severity Prevention Program," which are implemented by municipalities within the LIFE Study participating regions.
Key exclusion criteria - For Participants in the "Specific Health Guidance" Program:
Individuals already receiving medication for lifestyle-related diseases (diabetes, hypertension, or dyslipidemia) are not eligible for inclusion. Furthermore, individuals aged 75 or older are also not considered eligible. No other exclusion criteria will be set for this group.
For Participants in the "Disease Severity Prevention Program":
Individuals aged 75 or older are an exclusion criterion due to feasibility concerns regarding the implementation of the intervention. However, it should be noted that individuals already receiving medication for lifestyle-related diseases (diabetes, hypertension, or dyslipidemia) will not be excluded.
Target Size - 180
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 01 Day
Anticipated trial start date - 2025 Year 10 Month 01 Day
Last follow-up date - 2028 Year 09 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067506
Disclaimer: Curated by HT Syndication.