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Clinical Trials/NCT05476536
NCT05476536
Recruiting
Not Applicable

The Effectiveness of Technology Combined Self-health Management and Home Care Model Improved the Metabolic Diseases, Sarcopenia, and Serum Inflammation and Metabolic Markers Among Middle-aged and Elderly Individuals in the Community

Chang Gung University of Science and Technology1 site in 1 country200 target enrollmentFebruary 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Metabolic Disease
Sponsor
Chang Gung University of Science and Technology
Enrollment
200
Locations
1
Primary Endpoint
metabolic syndrome
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

The lifestyle program intervention program focusing on healthy dietary habit and exercise effectively prevents metabolic syndrome, sarcopenia or frailty. Thus, the purpose of this study was to assess the efficacy of 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 4th months. All participants complete a structured questionnaire, including basic information, SOF, physical performance, physical activity, and food-frequency.

Registry
clinicaltrials.gov
Start Date
February 15, 2023
End Date
July 31, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shu-Hung Chang

Professor

Chang Gung University of Science and Technology

Eligibility Criteria

Inclusion Criteria

  • older adult with age ≥ 40 years
  • community-dwelling
  • no hearing and visual acuity difficulties

Exclusion Criteria

  • Unconscious
  • Cognitive impairment or dementia

Outcomes

Primary Outcomes

metabolic syndrome

Time Frame: 4 month follow up

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

body weight

Time Frame: 4 month follow up

weight in kilograms

BMI

Time Frame: 4 month follow up

weight and height will be combined to report BMI in kg/m\^2

Frailty

Time Frame: 4 month follow up

measurement used study of osteoporotic fracture index (SOF).

Secondary Outcomes

  • physical agility and dynamic balance ability(4 month follow up)
  • short physical performance battery(4 month follow up)
  • upper limb muscle strength(4 month follow up)
  • static balance ability(4 month follow up)

Study Sites (1)

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