NCT04867239

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2014

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 23, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2014

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2014

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 30, 2021

Completed
Last Updated

May 4, 2021

Status Verified

April 1, 2021

Enrollment Period

6 months

First QC Date

April 27, 2021

Last Update Submit

April 29, 2021

Conditions

Metabolic Syndrome

Keywords

Metabolic SyndromeMotivationPatient EducationQuality of Life

Outcome Measures

Primary Outcomes (10)

  • Waist circumference (cm)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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

Study Arms (1)

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.

Other: A two-day education progra

Interventions

A two-day education prograOTHER

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

A two-day education program

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • people satisfied with metabolic syndrome criteria

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Sang Yeoup Lee, MD, PhD

    Pusan National University Yangsan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 27, 2021

First Posted

April 30, 2021

Study Start

May 23, 2014

Primary Completion

November 23, 2014

Study Completion

November 30, 2014

Last Updated

May 4, 2021

Record last verified: 2021-04