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

NCT ID: NCT05472298

Last Updated: 2022-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 137 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2019-07-31

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.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

intervention arm

lifestyle modification, goal setting, coaching and peer support, problem-solving, and self-monitoring

Group Type: EXPERIMENTAL

self-management intervention

Intervention Type: BEHAVIORAL

lifestyle modification, goal setting, coaching and peer support, problem-solving

control arm

education leaflet

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

self-management intervention

lifestyle modification, goal setting, coaching and peer support, problem-solving

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: collaborator

Chang Gung University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Shu-Hung Chang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shu-Hung Chang, Ph. D

Role: PRINCIPAL_INVESTIGATOR

Chang Gung University of Science and Technology

Locations

Taoyuan

Taoyuan District, , Taiwan

Countries

Taiwan

Other Identifiers

MOST 107-2314-B-255-006

Identifier Type: -

Identifier Source: org_study_id