Effectiveness of Technology for Metabolic Diseases Combined Sarcopenia

Not Applicable

Recruiting

• Conditions: Metabolic Disease
• Interventions: Behavioral: self-management skills and healthy technology APP

• Registration Number: NCT05476536
• Lead Sponsor: Chang Gung University of Science and Technology

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.

Study Timeline

• Study First Submitted: 2022-07-19
• Study First Submitted QC: 2022-07-25
• Study First Posted: 2022-07-27
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-08
• Study Start: 2023-02-15
• Primary Completion: 2023-07-31
• Study Completion: 2023-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

• Unconscious
• Cognitive impairment or dementia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental arm	self-management skills and healthy technology APP	self-management skills and healthy technology APP

Primary Outcome Measures

Name	Time	Method
body weight	4 month follow up	weight in kilograms
metabolic syndrome	4 month follow up	changes in triglycerides, high-density lipoprotein cholesterol, systolic blood pressure, diastolic blood pressure, fasting blood glucose, waist circumference
BMI	4 month follow up	weight and height will be combined to report BMI in kg/m\^2
Frailty	4 month follow up	measurement used study of osteoporotic fracture index (SOF).

Secondary Outcome Measures

Name	Time	Method
physical agility and dynamic balance ability	4 month follow up	Timed-Up and Go and Functional Reach Test
short physical performance battery	4 month follow up	sit-to-stand, standing balance, and gait-speed
upper limb muscle strength	4 month follow up	hand-grip strength
static balance ability	4 month follow up	single-leg standing with the eyes open

Trial Locations

Locations (1)

Taoyuan; 🇨🇳 Taoyuan, Taiwan