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Clinical Trials/NCT05472298
NCT05472298
Completed
Not Applicable

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

Chang Gung University of Science and Technology1 site in 1 country137 target enrollmentAugust 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Metabolic Syndrome
Sponsor
Chang Gung University of Science and Technology
Enrollment
137
Locations
1
Primary Endpoint
metabolic syndrome
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2017
End Date
July 31, 2019
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shu-Hung Chang

Professor

Chang Gung University of Science and Technology

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

Outcomes

Primary Outcomes

metabolic syndrome

Time Frame: 6 month, and 18-month follow up

changes in triglycerides, high-density lipoprotein cholesterol, systolic blood pressure, diastolic blood pressure, fasting blood glucose, waist circumference

Secondary Outcomes

  • BMI(6 months, and 18 months follow up)
  • body weight(6 months, and 18 months follow up)

Study Sites (1)

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