Effectiveness of Technology for Metabolic Diseases Combined Sarcopenia

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Metabolic Disease

Intervention / Treatment
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* Behavioral: self-management skills and healthy technology APP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: older adult with age ≥ 40 years community-dwelling no hearing and visual acuity difficulties Exclusion Criteria: Unconscious Cognitive impairment or dementia

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental arm<br>self-management skills and healthy technology APP | Behavioral: self-management skills and healthy technology APP<br>* self-management skills and healthy technology APP<br>|
| No Intervention: control group<br>Health education leaflet | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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self-health management, metabolic diseases, sarcopenia, frailty, intervention