Metabolic SyndromeNCT04867239
A Two-day Education Program for Metabolic Syndrome Patients
A study testing A two-day education progra in people with Metabolic Syndrome, run by Pusan National University Yangsan Hospital.
Trial summary
This study was to evaluate the temporal change of metabolic indicators and quality of life by a two-day patient education program. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- A two-day education progra
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- 23 May 2014to 30 Nov 2014
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- people satisfied with metabolic syndrome criteria
Who cannot join
- None
About this study
Official title: Temporal Changes of Metabolic Indicators and Quality of Life by a Two-day Patient Education Program for Metabolic Syndrome Patients
This study was to evaluate the temporal change of metabolic indicators and quality of life by a two-day patient education program.
Read the detailed description
This study aimed to evaluate whether a two-day multidisciplinary education camp comprising doctors, nurses, exercise instructors, dietitians, social workers, and health administrators could initiate healthy lifestyle habits, improve health markers though lifestyle modification, increase knowledge and understanding of the disease, and have a profitable effect on mental health in relation to depression and quality of life for patients with metabolic syndrome.
- Conditions
- Metabolic Syndrome
- Being tested
- A two-day education progra
- Keywords
- Metabolic Syndrome, Motivation, Patient Education, Quality of Life
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A two-day education prograOther
During the camp, the multidisciplinary team provided disease information, lifestyle modification, nutrition, and exercise.
| Study group | Role | What they receive |
|---|---|---|
| A two-day education program | Other | During the camp, the multidisciplinary team provided disease information, lifestyle modification, nutrition, and exercise for metabolic syndrome. Participants visited at 3- and 6-month after camp for follow-up. Receives: Other: A two-day education progra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waist circumference (cm)
Change in waist circumference at 3-month and 6-month after camp
Measured: Change from pre-camp at 3-month and 6-month after camp
Blood pressure (mmHg)
Change in blood pressure at 3-month and 6-month after camp
Measured: Change from pre-camp at 3-month and 6-month after camp
Korean version of EuroQol-5D (the minimum-maximum value, 0-1)
Change in score of Korean version of EuroQol-5D at 3-month and 6-month after camp. Higher scores mean a better outcome.
Measured: Change from pre-camp at 3-month and 6-month after camp
Korean version of Beck depression inventory-II (the minimum-maximum value, 0-63)
Change in score of Korean version of Beck depression inventory-II at 3-month and 6-month after camp. Higher scores mean a worse outcome.
Measured: Change from pre-camp at 3-month and 6-month after camp
Korean version of Beck anxiety inventory (the minimum-maximum value, 0-63)
Change in score of Korean version of Beck anxiety inventory at 3-month and 6-month after camp. Higher scores mean a worse outcome.
Measured: Change from pre-camp at 3-month and 6-month after camp
Nutritional knowledge score (the minimum-maximum value, 0-20)
Change in nutritional knowledge score at 3-month and 6-month after camp. Higher scores mean a better outcome.
Measured: Change from pre-camp at 3-month and 6-month after camp
Total cholesterol (mg/dL)
Change in total cholesterol (mg/dL) level at 3-month and 6-month after camp
Measured: Change from pre-camp at 3-month and 6-month after camp
Triglyceride (mg/dL)
Change in triglyceride (mg/dL) level at 3-month and 6-month after camp
Measured: Change from pre-camp at 3-month and 6-month after camp
HDL cholesterol (mg/dL)
Change in HDL cholesterol (mg/dL) level at 3-month and 6-month after camp
Measured: Change from pre-camp at 3-month and 6-month after camp
LDL cholesterol (mg/dL)
Change in LDL cholesterol (mg/dL) level at 3-month and 6-month after camp
Measured: Change from pre-camp at 3-month and 6-month after camp
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start23 May 2014
- Primary completion23 Nov 2014
- Study completion30 Nov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Yeoup Lee, Pusan National University Yangsan Hospital
- Investigators
- Sang Yeoup Lee, MD, PhD, Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04867239
- Sponsor's protocol ID
- 05-2014-039
- Status last verified
- Apr 2021
- First submitted
- 27 Apr 2021
- Last updated
- 4 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporal Changes of Metabolic Indicators and Quality of Life by a Two-day Patient Education Program for Metabolic Syndrome Patients
- ClinicalTrials.gov ID
- NCT04867239
- Acronym / sponsor ID
- 05-2014-039
- Conditions
- Metabolic Syndrome
- Keywords
- Metabolic Syndrome, Motivation, Patient Education, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 23 May 2014 (actual)
- Primary completion
- 23 Nov 2014 (actual)
- Study completion
- 30 Nov 2014 (actual)
- First posted
- 30 Apr 2021 (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.
This study was to evaluate the temporal change of metabolic indicators and quality of life by a two-day patient education program.
Detailed description
This study aimed to evaluate whether a two-day multidisciplinary education camp comprising doctors, nurses, exercise instructors, dietitians, social workers, and health administrators could initiate healthy lifestyle habits, improve health markers though lifestyle modification, increase knowledge and understanding of the disease, and have a profitable effect on mental health in relation to depression and quality of life for patients with metabolic syndrome.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A two-day education program | Other | Other: A two-day education prograDuring the camp, the multidisciplinary team provided disease information, lifestyle modification, nutrition, and exercise for metabolic syndrome. Participants visited at 3- and 6-month after camp for follow-up. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- people satisfied with metabolic syndrome criteria
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| A two-day education prograDuring the camp, the multidisciplinary team provided disease information, lifestyle modification, nutrition, and exercise. | Other | A two-day education program |
Primary outcome
Waist circumference (cm)
Time frame: Change from pre-camp at 3-month and 6-month after camp
Change in waist circumference at 3-month and 6-month after camp
Blood pressure (mmHg)
Time frame: Change from pre-camp at 3-month and 6-month after camp
Change in blood pressure at 3-month and 6-month after camp
Korean version of EuroQol-5D (the minimum-maximum value, 0-1)
Time frame: Change from pre-camp at 3-month and 6-month after camp
Change in score of Korean version of EuroQol-5D at 3-month and 6-month after camp. Higher scores mean a better outcome.
Korean version of Beck depression inventory-II (the minimum-maximum value, 0-63)
Time frame: Change from pre-camp at 3-month and 6-month after camp
Change in score of Korean version of Beck depression inventory-II at 3-month and 6-month after camp. Higher scores mean a worse outcome.
Korean version of Beck anxiety inventory (the minimum-maximum value, 0-63)
Time frame: Change from pre-camp at 3-month and 6-month after camp
Change in score of Korean version of Beck anxiety inventory at 3-month and 6-month after camp. Higher scores mean a worse outcome.
Nutritional knowledge score (the minimum-maximum value, 0-20)
Time frame: Change from pre-camp at 3-month and 6-month after camp
Change in nutritional knowledge score at 3-month and 6-month after camp. Higher scores mean a better outcome.
Total cholesterol (mg/dL)
Time frame: Change from pre-camp at 3-month and 6-month after camp
Change in total cholesterol (mg/dL) level at 3-month and 6-month after camp
Triglyceride (mg/dL)
Time frame: Change from pre-camp at 3-month and 6-month after camp
Change in triglyceride (mg/dL) level at 3-month and 6-month after camp
HDL cholesterol (mg/dL)
Time frame: Change from pre-camp at 3-month and 6-month after camp
Change in HDL cholesterol (mg/dL) level at 3-month and 6-month after camp
LDL cholesterol (mg/dL)
Time frame: Change from pre-camp at 3-month and 6-month after camp
Change in LDL cholesterol (mg/dL) level at 3-month and 6-month after camp
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
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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.
Sang Yeoup Lee, MD, PhD principal investigator
Pusan National University Yangsan Hospital
Questions about this trial
What is this clinical trial studying?
A study testing A two-day education progra in people with Metabolic Syndrome, run by Pusan National University Yangsan Hospital.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Waist circumference (cm) (time frame: Change from pre-camp at 3-month and 6-month after camp). The study lists 10 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 4 May 2021.