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

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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Behavioral: self-management intervention

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 Type: Interventional
• Enrollment (Actual): 137
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan
    • Taoyuan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention arm; lifestyle modification, goal setting, coaching and peer support, problem-solving, and self-monitoring	Behavioral: self-management intervention; lifestyle modification, goal setting, coaching and peer support, problem-solving
No Intervention: control arm; 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
leisure-time physical activity	moderate-vigorous leisure-time physical activity at least 150 minutes a week	6 months, and 18 months follow up
dietary behaviors	intake rate of whole grains, vegetables, fruits, proteins, dairy products, and nuts.	6 months, and 18 months follow up

Collaborators and Investigators

• Sponsor: Chang Gung University of Science and Technology
• Collaborators: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Shu-Hung Chang, Ph. D, Chang Gung University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: July 19, 2022
• First Submitted That Met QC Criteria: July 22, 2022
• First Posted (Actual): July 25, 2022

Study Record Updates

• Last Update Posted (Actual): July 25, 2022
• Last Update Submitted That Met QC Criteria: July 22, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: metabolic syndrome; women; self-management intervention
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: MOST 107-2314-B-255-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No