Effectiveness of Technology for Metabolic Diseases Combined Sarcopenia

Sponsor

Chang Gung University of Science and Technology (Other)

Overall Status

Recruiting

CT.gov ID

NCT05476536

Collaborator

Chang Gung Memorial Hospital (Other), Ministry of Science and Technology, Taiwan (Other)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

15.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Disease	Behavioral: self-management skills and healthy technology APP	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Jul 31, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

metabolic syndrome [4 month follow up]
changes in triglycerides, high-density lipoprotein cholesterol, systolic blood pressure, diastolic blood pressure, fasting blood glucose, waist circumference
body weight [4 month follow up]
weight in kilograms
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

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
physical agility and dynamic balance ability [4 month follow up]
Timed-Up and Go and Functional Reach Test

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

Unconscious
Cognitive impairment or dementia

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taoyuan	Taoyuan		Taiwan

Sponsors and Collaborators

Chang Gung University of Science and Technology
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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shu-Hung Chang, Professor, Chang Gung University of Science and Technology

ClinicalTrials.gov Identifier:

NCT05476536

Other Study ID Numbers:

MOST-110-2314-B-255-007-

First Posted:

Jul 27, 2022

Last Update Posted:

Jul 27, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Shu-Hung Chang, Professor, Chang Gung University of Science and Technology

self-health management

Additional relevant MeSH terms:

Sarcopenia

Metabolic Diseases

Study Results

No Results Posted as of Jul 27, 2022