Metabolic DiseaseNCT05476536
Effectiveness of Technology for Metabolic Diseases Combined Sarcopenia
A study testing self-management skills and healthy technology APP in people with Metabolic Disease, run by Chang Gung University of Science and Technology at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disease
- What is being tested?
- self-management skills and healthy technology APP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Feb 2023to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- older adult with age ≥ 40 years
- community-dwelling
- no hearing and visual acuity difficulties
Who cannot join
- Unconscious
- Cognitive impairment or dementia
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Metabolic Disease
- Being tested
- self-management skills and healthy technology APP
- Keywords
- self-health management, metabolic diseases, sarcopenia, frailty, intervention
- Medical subject headings
- Metabolic Diseases, Sarcopenia, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-management skills and healthy technology APPBehavioural
self-management skills and healthy technology APP
| Study group | Role | What they receive |
|---|---|---|
| experimental arm | Experimental | self-management skills and healthy technology APP Receives: Behavioral: self-management skills and healthy technology APP |
| control group | No intervention | Health education leaflet |
What is being measured
The primary outcome is the main question the study is designed to answer.
metabolic syndrome
changes in triglycerides, high-density lipoprotein cholesterol, systolic blood pressure, diastolic blood pressure, fasting blood glucose, waist circumference
Measured: 4 month follow up
body weight
weight in kilograms
Measured: 4 month follow up
BMI
weight and height will be combined to report BMI in kg/m^2
Measured: 4 month follow up
Frailty
measurement used study of osteoporotic fracture index (SOF).
Measured: 4 month follow up
Secondary outcomes (4)
short physical performance battery
sit-to-stand, standing balance, and gait-speed
Measured: 4 month follow up
upper limb muscle strength
hand-grip strength
Measured: 4 month follow up
static balance ability
single-leg standing with the eyes open
Measured: 4 month follow up
physical agility and dynamic balance ability
Timed-Up and Go and Functional Reach Test
Measured: 4 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start15 Feb 2023 (estimated)
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Chang Gung Memorial Hospital, Ministry of Science and Technology, Taiwan
- Responsible party
- Principal investigator, Shu-Hung Chang, Chang Gung University of Science and Technology
- Investigators
- Shu-Hung Chang, Ph.D, Principal investigator, Chang Gung University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05476536
- Sponsor's protocol ID
- MOST-110-2314-B-255-007-
- Status last verified
- Feb 2023
- First submitted
- 19 Jul 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05476536
- Acronym / sponsor ID
- MOST-110-2314-B-255-007-
- Conditions
- Metabolic Disease
- Keywords
- self-health management, metabolic diseases, sarcopenia, frailty, intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chang Gung University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Chang Gung Memorial Hospital, Ministry of Science and Technology, Taiwan
- Study start
- 15 Feb 2023 (estimated)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 27 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental arm | Experimental | Behavioral: self-management skills and healthy technology APPself-management skills and healthy technology APP |
| control group | No intervention | –Health education leaflet |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- older adult with age ≥ 40 years
- community-dwelling
- no hearing and visual acuity difficulties
Key exclusion criteria (2 listed)
- Unconscious
- Cognitive impairment or dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-management skills and healthy technology APPself-management skills and healthy technology APP | Behavioural | experimental arm |
Primary outcome
metabolic syndrome
Time frame: 4 month follow up
changes in triglycerides, high-density lipoprotein cholesterol, systolic blood pressure, diastolic blood pressure, fasting blood glucose, waist circumference
body weight
Time frame: 4 month follow up
weight in kilograms
BMI
Time frame: 4 month follow up
weight and height will be combined to report BMI in kg/m^2
Frailty
Time frame: 4 month follow up
measurement used study of osteoporotic fracture index (SOF).
4 secondary outcomes
short physical performance battery
Time frame: 4 month follow up
upper limb muscle strength
Time frame: 4 month follow up
static balance ability
Time frame: 4 month follow up
physical agility and dynamic balance ability
Time frame: 4 month follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shu-Hung Chang, Ph.D principal investigator
Chang Gung University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-management skills and healthy technology APP in people with Metabolic Disease, run by Chang Gung University of Science and Technology at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shu-Hung Chang, Ph.D (886-2118999 ext. 5150, shchang@mail.cgust.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
metabolic syndrome (time frame: 4 month follow up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.