Effectiveness of Self-Management Skills for Metabolic Syndrome Fatty Liver Disease Adults
- Conditions
- Metabolic Syndrome
- Interventions
- Behavioral: self-management intervention
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 137
- 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
- Unconscious
- Cognitive impairment or dementia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description intervention arm self-management intervention lifestyle modification, goal setting, coaching and peer support, problem-solving, and self-monitoring
- 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