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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05472298
• Other study ID #: MOST 107-2314-B-255-006
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: July 31, 2019

Study information

• Verified date: July 2022
• Source: Chang Gung University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

Behavioral:
• self-management intervention
lifestyle modification, goal setting, coaching and peer support, problem-solving

Locations

Country	Name	City	State
Taiwan	Taoyuan	Taoyuan

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung University of Science and Technology	Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	leisure-time physical activity	moderate-vigorous leisure-time physical activity at least 150 minutes a week	6 months, and 18 months follow up
Other	dietary behaviors	intake rate of whole grains, vegetables, fruits, proteins, dairy products, and nuts.	6 months, and 18 months follow up
Primary	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	body weight	weight in kilograms	6 months, and 18 months follow up
Secondary	BMI	weight and height will be combined to report BMI in kg/m^2	6 months, and 18 months follow up