Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06271200
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-02-06
Brief Title:
Strategic Lifestyle Intervention for Metabolic Syndrome SLIM-MET
Sponsor:
National Health Research Institutes Taiwan
Organization:
National Health Research Institutes Taiwan
Study Overview
Official Title:
Effects of Intensive Lifestyle Interventions ILI on Weight Loss and Cardiometabolic Risks in Obese Adults With Metabolic Syndrome A Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a randomized parallel-group observer-masked clinical trial A total of 120 obese participants with MetS will be enrolled Eligible subjects will be randomly assigned to the ILI group or ULI group with an allocation ratio of 21 The ILI group will be instructed to eat in 8 hours while fasting in 16 hours on daily basis over 24 weeks Furthermore enhanced daily physical activities with walking more than 10000 steps will be implemented The enrolled participants will be instructed to follow a diet with reduction of daily intake of 500 kcals per day ILI group will be asked to use the Health2Sync mobile app to track self-measured outcomes and daily diet control The investigators objectively measure step counts for participants of ILI group during 24-week intervention period using a wearable device Fitbit Inspire 2 Participants are asked to attach the pedometer on their waist belt except while bathing and sleeping The ULI group will be instructed to follow habitual meal timing In addition all participants of both groups will receive the health education Anthropometric sociodemographic data biochemical variables and metabolic variables will be measured at baseline and during follow-up visit DEXA and MRI of abdomen will be measured at baseline and during following up visits The proposed trial is designed to provide 85 statistical power to detect a significant difference in changes in the metabolic syndrome severity score after reduction 5 body weight over 24 weeks
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None