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A Two-day Education Program for Metabolic Syndrome Patients

Primary Purpose

Metabolic Syndrome

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

A two-day education progra

About this trial

This is an interventional supportive care trial for Metabolic Syndrome focused on measuring Metabolic Syndrome, Motivation, Patient Education, Quality of Life

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

people satisfied with metabolic syndrome criteria

Exclusion Criteria:

None

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

A two-day education program

Arm Description

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.

Outcomes

Primary Outcome Measures

Waist circumference (cm)

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

Blood pressure (mmHg)

Change in blood pressure 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.

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.

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.

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.

Total cholesterol (mg/dL)

Change in total cholesterol (mg/dL) level 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

HDL cholesterol (mg/dL)

Change in HDL cholesterol (mg/dL) level 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

Secondary Outcome Measures

Full Information

NCT ID

NCT04867239

First Posted

April 27, 2021

Last Updated

April 29, 2021

Sponsor

Pusan National University Yangsan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04867239

Brief Title

A Two-day Education Program for Metabolic Syndrome Patients

Official Title

Temporal Changes of Metabolic Indicators and Quality of Life by a Two-day Patient Education Program for Metabolic Syndrome Patients

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

May 23, 2014 (Actual)

Primary Completion Date

November 23, 2014 (Actual)

Study Completion Date

November 30, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Pusan National University Yangsan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome

Keywords

Metabolic Syndrome, Motivation, Patient Education, Quality of Life

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A two-day education program

Arm Type

Other

Arm Description

Intervention Type

Other

Intervention Name(s)

A two-day education progra

Intervention Description

During the camp, the multidisciplinary team provided disease information, lifestyle modification, nutrition, and exercise.

Primary Outcome Measure Information:

Title

Waist circumference (cm)

Description

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

Time Frame