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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05472298
Enrollment
137
Registered
2022-07-25
Start date
2017-08-01
Completion date
2019-07-31
Last updated
2022-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome

Keywords

self-management intervention, metabolic syndrome, women

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.

Interventions

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

Sponsors

Chang Gung Memorial Hospital
CollaboratorOTHER
Chang Gung University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
50 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
metabolic syndrome6 month, and 18-month follow upchanges in triglycerides, high-density lipoprotein cholesterol, systolic blood pressure, diastolic blood pressure, fasting blood glucose, waist circumference

Secondary

MeasureTime frameDescription
body weight6 months, and 18 months follow upweight in kilograms
BMI6 months, and 18 months follow upweight and height will be combined to report BMI in kg/m\^2

Other

MeasureTime frameDescription
leisure-time physical activity6 months, and 18 months follow upmoderate-vigorous leisure-time physical activity at least 150 minutes a week
dietary behaviors6 months, and 18 months follow upintake rate of whole grains, vegetables, fruits, proteins, dairy products, and nuts.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026