Effectiveness of Self-Management Skills for Metabolic Syndrome Fatty Liver Disease Adults

Not Applicable

Completed

• Conditions: Metabolic Syndrome

• Registration Number: NCT05472298
• Lead Sponsor: Chang Gung University of Science and Technology

Brief Summary

The multidimensional self-management intervention program focusing on healthy dietary habit and exercise effectively prevents metabolic syndrome. Thus, the purpose of this study was to assess the efficacy of multidimensional self-management intervention program on metabolic syndrome subjects in Taiwan.

Detailed Description

The study is a 2-parallel groups' randomized controlled trial. Participants with metabolic syndrome (three or more risk factors - triglycerides (TG) \>150 mg/dL, systolic blood pressure (SBP) ≥130 mm Hg, diastolic blood pressure (DBP) ≥85 mm Hg, or fasting blood glucose≥100 mg/dL; high-density lipoprotein cholesterol\<50 mg/dL, or waist circumference ≥80 cm) are enrolled. The four community units are randomized to receive a lifestyle intervention (intervention arm) or an education leaflet (control arm). The parameters are obtained from physical examination and biochemical assessments by well-trained case manager at baseline and each follow visit (6th months and 18th months). All participants complete a structured questionnaire, including basic information, physical activity, and food-frequency.

Study Timeline

• Study Start: 2017-08-01
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Status Verified: 2022-07
• Study First Submitted: 2022-07-19
• Study First Submitted QC: 2022-07-22
• Last Update Submitted: 2022-07-22
• Study First Posted: 2022-07-25
• Last Update Posted: 2022-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 137

Inclusion Criteria

• adult women with age ≥ 50 years
• low education, defined as having less than 6 years of education or being primary school graduates
• presence of metabolic syndrome
• community-dwelling
• no hearing and visual acuity difficulties

Exclusion Criteria

• Unconscious
• Cognitive impairment or dementia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
metabolic syndrome	6 month, and 18-month follow up	changes in triglycerides, high-density lipoprotein cholesterol, systolic blood pressure, diastolic blood pressure, fasting blood glucose, waist circumference

Secondary Outcome Measures

Name	Time	Method
BMI	6 months, and 18 months follow up	weight and height will be combined to report BMI in kg/m\^2
body weight	6 months, and 18 months follow up	weight in kilograms

Trial Locations

Locations (1)

Taoyuan; 🇨🇳 Taoyuan, Taiwan