A project to develop the supporting system for scaling up the Personalized Intensive Lifestyle Modification/coaching Program

Phase 2

• Conditions: Adults aged 18-70 years old with metabolic risk; metabolic syndrome; coaching; personalized lifestyle modification; lifestyle medicine

• Registration Number: TCTR20230705004
• Lead Sponsor: Thai Health Promotion Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-05
• Last Update Posted: 19 August 2024
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. adults aged 18-70 years old
2. meet at least one of the International Diabetes Federation (IDF) criteria for metabolic syndrome including
2.1 Central obesity (waist circumference 90 cm or higher in men and 80 cm or higher in women in Asian population)
2.2 Elevated triglycerides 150 milligrams per deciliter of blood (mg/dL) or greater (drug treatment for elevated triglycerides is an alternate indicator)
2.3 Reduced high-density lipoprotein cholesterol (HDL) less than 40 mg/dL in men or less than 50 mg/dL in women (drug treatment for reduced HDL-C is an alternate indicator)
2.4 Elevated fasting plasma glucose of l00 mg/dL or greater (drug treatment of elevated glucose is an alternate indicator)
2.5 Blood pressure values of systolic 130 mmHg or higher and/or diastolic 85 mmHg or higher (antihypertensive drug treatment in a patient with a history of hypertension is an alternate indicator)

Exclusion Criteria

1. Having a health condition that prohibits exercise, such as being recently diagnosed with ischemic heart disease or having had a stroke within the past month, having excessively low or high blood pressure, or experiencing uncontrolled arrhythmia or a recent heart attack.
2. Unable to be monitored or tracked for a period of 12 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body mass index at 6 and 12 months Body mass index,Waist circumference at 6 and 12 months Waist circumference,Waist-to-hip ratio; WHR at 6 and 12 months Waist-to-hip ratio; WHR,Muscle strength at 6 and 12 months Sit to stand, Push-up,Cardiorespiratory fitness test at 6 and 12 months 6 Minute walk test; 6MWT,Flexibility at 6 and 12 months YMCA, V-sit-and-reach,Balance at 6 and 12 months Single leg balance test,stress at 6 and 12 months ST-5,Depression at 6 and 12 months 9Q, 8Q,Blood biomarkers for metabolic disease at 6 and 12 months Fasting blood sugar, HBA1c, Low-density lipoprotein, High-density lipoprotein, Total cholesterol, Triglyceride

Secondary Outcome Measures

Name	Time	Method
adverse event at 6 and 12 months clinical assessment