NCT04530331

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
214

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2010

Longer than P75 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

March 8, 2010

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2013

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2015

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 28, 2020

Completed
Last Updated

September 1, 2020

Status Verified

August 1, 2020

Enrollment Period

3.8 years

First QC Date

August 25, 2020

Last Update Submit

August 28, 2020

Conditions

Outcome Measures

Primary Outcomes (7)

  • BMI

    To evaluate the effect of nutrition education on the reduction of BMI (body mass index).

    After 8 week intervention

  • Waist circumference

    One of the metabolic syndrome factors.

    After 8 week intervention

  • Systolic blood pressure

    One of the metabolic syndrome factors.

    After 8 week intervention

  • Diastolic blood pressure

    One of the metabolic syndrome factors.

    After 8 week intervention

  • Fasting blood sugar

    One of the metabolic syndrome factors.

    After 8 week intervention

  • Serum triglyceride

    One of the metabolic syndrome factors.

    After 8 week intervention

  • Serum high density lipoprotein cholesterol

    One of the metabolic syndrome factors.

    After 8 week intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

Providing nutrition education.

Behavioral: Nutrition education

Control group

NO INTERVENTION

Without any intervention.

Interventions

Dietitians visited the worksites of the intervention group once a week to deliver a nutrition education session and provide dietary advice for each participant.

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 18 years old
  • BMI of ≥ 22

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Metabolic SyndromeHealth Education

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

August 25, 2020

First Posted

August 28, 2020

Study Start

March 8, 2010

Primary Completion

December 15, 2013

Study Completion

December 18, 2015

Last Updated

September 1, 2020

Record last verified: 2020-08