search
Back to results

Effectiveness of Technology for Metabolic Diseases Combined Sarcopenia

Primary Purpose

Metabolic Disease

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
self-management skills and healthy technology APP
Sponsored by
Chang Gung University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Disease focused on measuring self-health management, metabolic diseases, sarcopenia, frailty, intervention

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Unconscious
  • Cognitive impairment or dementia

Sites / Locations

  • TaoyuanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

experimental arm

control group

Arm Description

self-management skills and healthy technology APP

Health education leaflet

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 19, 2022
Last Updated
February 7, 2023
Sponsor
Chang Gung University of Science and Technology
Collaborators
Chang Gung Memorial Hospital, Ministry of Science and Technology, Taiwan
search

1. Study Identification

Unique Protocol Identification Number
NCT05476536
Brief Title
Effectiveness of Technology for Metabolic Diseases Combined Sarcopenia
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2023 (Anticipated)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung University of Science and Technology
Collaborators
Chang Gung Memorial Hospital, Ministry of Science and Technology, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Disease
Keywords
self-health management, metabolic diseases, sarcopenia, frailty, intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental arm
Arm Type
Experimental
Arm Description
self-management skills and healthy technology APP
Arm Title
control group
Arm Type
No Intervention
Arm Description
Health education leaflet
Intervention Type
Behavioral
Intervention Name(s)
self-management skills and healthy technology APP
Intervention Description
self-management skills and healthy technology APP
Primary Outcome Measure Information:
Title
metabolic syndrome
Description
changes in triglycerides, high-density lipoprotein cholesterol, systolic blood pressure, diastolic blood pressure, fasting blood glucose, waist circumference
Time Frame
4 month follow up
Title
body weight
Description
weight in kilograms
Time Frame
4 month follow up
Title
BMI
Description
weight and height will be combined to report BMI in kg/m^2
Time Frame
4 month follow up
Title
Frailty
Description
measurement used study of osteoporotic fracture index (SOF).
Time Frame
4 month follow up
Secondary Outcome Measure Information:
Title
short physical performance battery
Description
sit-to-stand, standing balance, and gait-speed
Time Frame
4 month follow up
Title
upper limb muscle strength
Description
hand-grip strength
Time Frame
4 month follow up
Title
static balance ability
Description
single-leg standing with the eyes open
Time Frame
4 month follow up
Title
physical agility and dynamic balance ability
Description
Timed-Up and Go and Functional Reach Test
Time Frame
4 month follow up
Other Pre-specified Outcome Measures:
Title
Physical activity
Description
used International Physical Activity Questionnaire (IPAQ)
Time Frame
4 month follow up
Title
dietary behaviors
Description
intake rate of whole grains, vegetables, fruits, proteins, dairy products, and nuts.
Time Frame
4 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shu-Hung Chang, Ph.D
Phone
886-2118999
Ext
5150
Email
shchang@mail.cgust.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shu-Hung Chang, Ph.D
Organizational Affiliation
Chang Gung University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taoyuan
City
Taoyuan
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shu-Hung Chang, Ph.D

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effectiveness of Technology for Metabolic Diseases Combined Sarcopenia

We'll reach out to this number within 24 hrs