search
Back to results

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
Lotung Poh-Ai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    August 25, 2020
    Last Updated
    August 28, 2020
    Sponsor
    Lotung Poh-Ai Hospital
    search

    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

    We'll reach out to this number within 24 hrs