Job-Site Diet Education on Metabolic Syndrome
Primary Purpose
Metabolic Syndrome, Health Education, Workplace
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nutrition education
Sponsored by
About this trial
This is an interventional prevention trial for Metabolic Syndrome
Eligibility Criteria
Inclusion Criteria:
- ≥ 18 years old
- BMI of ≥ 22
Exclusion Criteria:
- History of critical illness
- Having been diagnosed with at least one endocrine disorder
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
Providing nutrition education.
Without any intervention.
Outcomes
Primary Outcome Measures
BMI
To evaluate the effect of nutrition education on the reduction of BMI (body mass index).
Waist circumference
One of the metabolic syndrome factors.
Systolic blood pressure
One of the metabolic syndrome factors.
Diastolic blood pressure
One of the metabolic syndrome factors.
Fasting blood sugar
One of the metabolic syndrome factors.
Serum triglyceride
One of the metabolic syndrome factors.
Serum high density lipoprotein cholesterol
One of the metabolic syndrome factors.
Secondary Outcome Measures
Full Information
NCT ID
NCT04530331
First Posted
August 25, 2020
Last Updated
August 28, 2020
Sponsor
Lotung Poh-Ai Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04530331
Brief Title
Job-Site Diet Education on Metabolic Syndrome
Official Title
Work-Site Nutrition Education and Metabolic Syndrome Factors
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
March 8, 2010 (Actual)
Primary Completion Date
December 15, 2013 (Actual)
Study Completion Date
December 18, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lotung Poh-Ai Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study conducted an 8-week workplace nutrition education intervention to examine the effects of the intervention on metabolic syndrome factors associated with employees. A historical intervention was designed to recruit adults with a body mass index level of >22 and without any endocrine disorder from a community in Yilan, Taiwan. The intervention group was recruited between 2010 and 2012 and received an 8-week intervention, during which dietitians delivered a nutrition education session and a one-on-one dietary guidance session on a weekly basis. The age- and sex-matched control group (n = 34) was recruited between 2014 and 2015 to analyze the metabolic syndrome variables. The metabolic syndrome variables included blood pressure, blood sugar, serum lipid profile, and waist circumference.
Detailed Description
Content of classes Week1 Things that you must know during the weight reduction study period Week2 Daily individual calorie requirement: what are the main food groups? Week3 How to record the daily diet after the weight reduction program Week4 Food serving size and replacement Week5 The principles of eating out Week6 Physical activity advice (delivered with health education flyers to the participants)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Health Education, Workplace
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
214 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Providing nutrition education.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Without any intervention.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition education
Intervention Description
Dietitians visited the worksites of the intervention group once a week to deliver a nutrition education session and provide dietary advice for each participant.
Primary Outcome Measure Information:
Title
BMI
Description
To evaluate the effect of nutrition education on the reduction of BMI (body mass index).
Time Frame
After 8 week intervention
Title
Waist circumference
Description
One of the metabolic syndrome factors.
Time Frame
After 8 week intervention
Title
Systolic blood pressure
Description
One of the metabolic syndrome factors.
Time Frame
After 8 week intervention
Title
Diastolic blood pressure
Description
One of the metabolic syndrome factors.
Time Frame
After 8 week intervention
Title
Fasting blood sugar
Description
One of the metabolic syndrome factors.
Time Frame
After 8 week intervention
Title
Serum triglyceride
Description
One of the metabolic syndrome factors.
Time Frame
After 8 week intervention
Title
Serum high density lipoprotein cholesterol
Description
One of the metabolic syndrome factors.
Time Frame
After 8 week intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
≥ 18 years old
BMI of ≥ 22
Exclusion Criteria:
History of critical illness
Having been diagnosed with at least one endocrine disorder
12. IPD Sharing Statement
Learn more about this trial
Job-Site Diet Education on Metabolic Syndrome
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