- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04867239
A Two-day Education Program for Metabolic Syndrome Patients
April 29, 2021 updated by: Sang Yeoup Lee, Pusan National University Yangsan Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
29
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- people satisfied with metabolic syndrome criteria
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: A two-day education program
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.
|
During the camp, the multidisciplinary team provided disease information, lifestyle modification, nutrition, and exercise.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Change from pre-camp 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
|
Change from pre-camp 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.
|
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)
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.
|
Change from pre-camp at 3-month and 6-month after camp
|
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.
|
Change from pre-camp at 3-month and 6-month after camp
|
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.
|
Change from pre-camp at 3-month and 6-month after camp
|
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
|
Change from pre-camp 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
|
Change from pre-camp 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
|
Change from pre-camp 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
|
Change from pre-camp at 3-month and 6-month after camp
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 23, 2014
Primary Completion (Actual)
November 23, 2014
Study Completion (Actual)
November 30, 2014
Study Registration Dates
First Submitted
April 27, 2021
First Submitted That Met QC Criteria
April 27, 2021
First Posted (Actual)
April 30, 2021
Study Record Updates
Last Update Posted (Actual)
May 4, 2021
Last Update Submitted That Met QC Criteria
April 29, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05-2014-039
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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