Effectiveness of Technology for Metabolic Diseases Combined Sarcopenia

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

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.

Study Overview

• Status: Recruiting
• Conditions: Metabolic Disease
• Intervention / Treatment: Behavioral: self-management skills and healthy technology APP

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shu-Hung Chang, Ph.D; Phone Number: 5150 886-2118999; Email: shchang@mail.cgust.edu.tw

Study Locations

• Taiwan
  • Taoyuan, Taiwan
    • Recruiting
    • Taoyuan
    • Contact: Shu-Hung Chang, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Unconscious
• Cognitive impairment or dementia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: experimental arm; self-management skills and healthy technology APP	Behavioral: self-management skills and healthy technology APP; self-management skills and healthy technology APP
NO_INTERVENTION: control group; Health education leaflet

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity	used International Physical Activity Questionnaire (IPAQ)	4 month follow up
dietary behaviors	intake rate of whole grains, vegetables, fruits, proteins, dairy products, and nuts.	4 month follow up

Collaborators and Investigators

• Sponsor: Chang Gung University of Science and Technology
• Collaborators: Chang Gung Memorial Hospital; Ministry of Science and Technology, Taiwan
• Investigators: Principal Investigator: Shu-Hung Chang, Ph.D, Chang Gung University of Science and Technology

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 15, 2023
• Primary Completion (ANTICIPATED): July 31, 2023
• Study Completion (ANTICIPATED): July 31, 2023

Study Registration Dates

• First Submitted: July 19, 2022
• First Submitted That Met QC Criteria: July 25, 2022
• First Posted (ACTUAL): July 27, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: frailty; intervention; sarcopenia; metabolic diseases; self-health management
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia; Metabolic Diseases
• Other Study ID Numbers: MOST-110-2314-B-255-007-

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No