A Two-day Education Program for Metabolic Syndrome Patients

• Sponsor: Pusan National University Yangsan Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04867239
• Collaborator: (none)
• Enrollment: 29
• Arm: 1
• Actual Duration (Months): 6.3

Study Details

Study Description

Brief Summary

This study was to evaluate the temporal change of metabolic indicators and quality of life by a two-day patient education program.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome	Other: A two-day education progra	N/A

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

• Study Type: Interventional
• Actual Enrollment: 29 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Temporal Changes of Metabolic Indicators and Quality of Life by a Two-day Patient Education Program for Metabolic Syndrome Patients
• Actual Study Start Date: May 23, 2014
• Actual Primary Completion Date: Nov 23, 2014
• Actual Study Completion Date: Nov 30, 2014

Arms and Interventions

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.	Other: A two-day education progra; During the camp, the multidisciplinary team provided disease information, lifestyle modification, nutrition, and exercise.

Outcome Measures

Primary Outcome Measures

1. Waist circumference (cm) [Change from pre-camp at 3-month and 6-month after camp]

   Change in waist circumference at 3-month and 6-month after camp

2. Blood pressure (mmHg) [Change from pre-camp at 3-month and 6-month after camp]

   Change in blood pressure at 3-month and 6-month after camp

3. Korean version of EuroQol-5D (the minimum-maximum value, 0-1) [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.

4. Korean version of Beck depression inventory-II (the minimum-maximum value, 0-63) [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.

5. Korean version of Beck anxiety inventory (the minimum-maximum value, 0-63) [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.

6. Nutritional knowledge score (the minimum-maximum value, 0-20) [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.

7. Total cholesterol (mg/dL) [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

8. Triglyceride (mg/dL) [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

9. HDL cholesterol (mg/dL) [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

10. LDL cholesterol (mg/dL) [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• people satisfied with metabolic syndrome criteria

Exclusion Criteria:

• None

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Pusan National University Yangsan Hospital

Investigators

• Principal Investigator: Sang Yeoup Lee, MD, PhD, Pusan National University Yangsan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sang Yeoup Lee, Professor, Pusan National University Yangsan Hospital
• ClinicalTrials.gov Identifier: NCT04867239
• Other Study ID Numbers: 05-2014-039
• First Posted: Apr 30, 2021
• Last Update Posted: May 4, 2021
• Last Verified: Apr 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sang Yeoup Lee, Professor, Pusan National University Yangsan Hospital: Metabolic Syndrome; Motivation; Patient Education; Quality of Life
• Additional relevant MeSH terms: Metabolic Syndrome; Syndrome

Study Results

No Results Posted as of May 4, 2021