Effectiveness of Self-Management Skills for Metabolic Syndrome Fatty Liver Disease Adults
Primary Purpose
Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
self-management intervention
Sponsored by
About this trial
This is an interventional prevention trial for Metabolic Syndrome focused on measuring self-management intervention, metabolic syndrome, women
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
Sites / Locations
- Taoyuan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervention arm
control arm
Arm Description
lifestyle modification, goal setting, coaching and peer support, problem-solving, and self-monitoring
education leaflet
Outcomes
Primary Outcome Measures
metabolic syndrome
changes in triglycerides, high-density lipoprotein cholesterol, systolic blood pressure, diastolic blood pressure, fasting blood glucose, waist circumference
Secondary Outcome Measures
body weight
weight in kilograms
BMI
weight and height will be combined to report BMI in kg/m^2
Full Information
NCT ID
NCT05472298
First Posted
July 19, 2022
Last Updated
July 22, 2022
Sponsor
Chang Gung University of Science and Technology
Collaborators
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05472298
Brief Title
Effectiveness of Self-Management Skills for Metabolic Syndrome Fatty Liver Disease Adults
Official Title
The Effectiveness of Self-Management Skills and Technology in Individuals Who Have Both Metabolic Syndrome in Community
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung University of Science and Technology
Collaborators
Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
self-management intervention, metabolic syndrome, women
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
137 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention arm
Arm Type
Experimental
Arm Description
lifestyle modification, goal setting, coaching and peer support, problem-solving, and self-monitoring
Arm Title
control arm
Arm Type
No Intervention
Arm Description
education leaflet
Intervention Type
Behavioral
Intervention Name(s)
self-management intervention
Intervention Description
lifestyle modification, goal setting, coaching and peer support, problem-solving
Primary Outcome Measure Information:
Title
metabolic syndrome
Description
changes in triglycerides, high-density lipoprotein cholesterol, systolic blood pressure, diastolic blood pressure, fasting blood glucose, waist circumference
Time Frame
6 month, and 18-month follow up
Secondary Outcome Measure Information:
Title
body weight
Description
weight in kilograms
Time Frame
6 months, and 18 months follow up
Title
BMI
Description
weight and height will be combined to report BMI in kg/m^2
Time Frame
6 months, and 18 months follow up
Other Pre-specified Outcome Measures:
Title
leisure-time physical activity
Description
moderate-vigorous leisure-time physical activity at least 150 minutes a week
Time Frame
6 months, and 18 months follow up
Title
dietary behaviors
Description
intake rate of whole grains, vegetables, fruits, proteins, dairy products, and nuts.
Time Frame
6 months, and 18 months follow up
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
adult women with age ≥ 50 years, low education, defined as having less than 6 years of education or being primary school graduates
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shu-Hung Chang, Ph. D
Organizational Affiliation
Chang Gung University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taoyuan
City
Taoyuan
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of Self-Management Skills for Metabolic Syndrome Fatty Liver Disease Adults
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