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

Study Overview
=================
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.

Official Title
-----------------
The Effectiveness of Self-Management Skills and Technology in Individuals Who Have Both Metabolic Syndrome in Community

Conditions
-----------------
Metabolic Syndrome

Intervention / Treatment
-----------------
* Behavioral: self-management intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention arm<br>lifestyle modification, goal setting, coaching and peer support, problem-solving, and self-monitoring | Behavioral: self-management intervention<br>* lifestyle modification, goal setting, coaching and peer support, problem-solving<br>|
| No Intervention: control arm<br>education leaflet | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| metabolic syndrome | changes in triglycerides, high-density lipoprotein cholesterol, systolic blood pressure, diastolic blood pressure, fasting blood glucose, waist circumference | 6 month, and 18-month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body weight | weight in kilograms | 6 months, and 18 months follow up | 
| BMI | weight and height will be combined to report BMI in kg/m^2 | 6 months, and 18 months follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
women, self-management intervention, metabolic syndrome