Job-Site Diet Education on Metabolic Syndrome

Sponsor

Lotung Poh-Ai Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04530331

Collaborator

(none)

214

Enrollment

Arms

69.4

Actual Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome Health Education Workplace	Behavioral: Nutrition education	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

214 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Work-Site Nutrition Education and Metabolic Syndrome Factors

Actual Study Start Date :

Mar 8, 2010

Actual Primary Completion Date :

Dec 15, 2013

Actual Study Completion Date :

Dec 18, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group Providing nutrition education.	Behavioral: 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.

Arm

Intervention/Treatment

Experimental: Intervention group

Providing nutrition education.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

BMI [After 8 week intervention]
To evaluate the effect of nutrition education on the reduction of BMI (body mass index).
Waist circumference [After 8 week intervention]
One of the metabolic syndrome factors.
Systolic blood pressure [After 8 week intervention]
One of the metabolic syndrome factors.
Diastolic blood pressure [After 8 week intervention]
One of the metabolic syndrome factors.
Fasting blood sugar [After 8 week intervention]
One of the metabolic syndrome factors.
Serum triglyceride [After 8 week intervention]
One of the metabolic syndrome factors.
Serum high density lipoprotein cholesterol [After 8 week intervention]
One of the metabolic syndrome factors.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

≥ 18 years old
BMI of ≥ 22

Exclusion Criteria:

History of critical illness
Having been diagnosed with at least one endocrine disorder

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Lotung Poh-Ai Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hsien-Cheng Chang, Director, Lotung Poh-Ai Hospital

ClinicalTrials.gov Identifier:

NCT04530331

Other Study ID Numbers:

Lotung Poh-Ai Hospital

First Posted:

Aug 28, 2020

Last Update Posted:

Sep 1, 2020

Last Verified:

Aug 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Metabolic Syndrome

Syndrome

Study Results

No Results Posted as of Sep 1, 2020