- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04530331
Job-Site Diet Education on Metabolic Syndrome
August 28, 2020 updated by: Hsien-Cheng Chang, Lotung Poh-Ai Hospital
Work-Site Nutrition Education and Metabolic Syndrome Factors
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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)
Study Type
Interventional
Enrollment (Actual)
214
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ≥ 18 years old
- BMI of ≥ 22
Exclusion Criteria:
- History of critical illness
- Having been diagnosed with at least one endocrine disorder
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: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
Providing nutrition education.
|
Dietitians visited the worksites of the intervention group once a week to deliver a nutrition education session and provide dietary advice for each participant.
|
No Intervention: Control group
Without any intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BMI
Time Frame: After 8 week intervention
|
To evaluate the effect of nutrition education on the reduction of BMI (body mass index).
|
After 8 week intervention
|
Waist circumference
Time Frame: After 8 week intervention
|
One of the metabolic syndrome factors.
|
After 8 week intervention
|
Systolic blood pressure
Time Frame: After 8 week intervention
|
One of the metabolic syndrome factors.
|
After 8 week intervention
|
Diastolic blood pressure
Time Frame: After 8 week intervention
|
One of the metabolic syndrome factors.
|
After 8 week intervention
|
Fasting blood sugar
Time Frame: After 8 week intervention
|
One of the metabolic syndrome factors.
|
After 8 week intervention
|
Serum triglyceride
Time Frame: After 8 week intervention
|
One of the metabolic syndrome factors.
|
After 8 week intervention
|
Serum high density lipoprotein cholesterol
Time Frame: After 8 week intervention
|
One of the metabolic syndrome factors.
|
After 8 week intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
March 8, 2010
Primary Completion (Actual)
December 15, 2013
Study Completion (Actual)
December 18, 2015
Study Registration Dates
First Submitted
August 25, 2020
First Submitted That Met QC Criteria
August 25, 2020
First Posted (Actual)
August 28, 2020
Study Record Updates
Last Update Posted (Actual)
September 1, 2020
Last Update Submitted That Met QC Criteria
August 28, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Lotung Poh-Ai Hospital
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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