Metabolic SyndromeNCT04530331
Job-Site Diet Education on Metabolic Syndrome
A study testing Nutrition education in people with Metabolic Syndrome and Health Education, run by Lotung Poh-Ai Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Health Education, Workplace
- What is being tested?
- Nutrition education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- No sites listed yet
- Study dates
- 8 Mar 2010to 18 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 18 years old
- BMI of ≥ 22
Who cannot join
- History of critical illness
- Having been diagnosed with at least one endocrine disorder
About this study
Official title: 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.
Read the 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)
- Conditions
- Metabolic Syndrome, Health Education, Workplace
- Being tested
- Nutrition education
- Medical subject headings
- Metabolic Syndrome, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition educationBehavioural
Dietitians visited the worksites of the intervention group once a week to deliver a nutrition education session and provide dietary advice for each participant.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Providing nutrition education. Receives: Behavioral: Nutrition education |
| Control group | No intervention | Without any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
To evaluate the effect of nutrition education on the reduction of BMI (body mass index).
Measured: After 8 week intervention
Waist circumference
One of the metabolic syndrome factors.
Measured: After 8 week intervention
Systolic blood pressure
One of the metabolic syndrome factors.
Measured: After 8 week intervention
Diastolic blood pressure
One of the metabolic syndrome factors.
Measured: After 8 week intervention
Fasting blood sugar
One of the metabolic syndrome factors.
Measured: After 8 week intervention
Serum triglyceride
One of the metabolic syndrome factors.
Measured: After 8 week intervention
Serum high density lipoprotein cholesterol
One of the metabolic syndrome factors.
Measured: After 8 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start8 Mar 2010
- Primary completion15 Dec 2013
- Study completion18 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lotung Poh-Ai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsien-Cheng Chang, Lotung Poh-Ai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04530331
- Sponsor's protocol ID
- Lotung Poh-Ai Hospital
- Status last verified
- Aug 2020
- First submitted
- 25 Aug 2020
- Last updated
- 1 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Work-Site Nutrition Education and Metabolic Syndrome Factors
- ClinicalTrials.gov ID
- NCT04530331
- Acronym / sponsor ID
- Lotung Poh-Ai Hospital
- Conditions
- Metabolic Syndrome, Health Education, Workplace
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Lotung Poh-Ai HospitalUniversity, hospital or other
- Study start
- 8 Mar 2010 (actual)
- Primary completion
- 15 Dec 2013 (actual)
- Study completion
- 18 Dec 2015 (actual)
- First posted
- 28 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Nutrition educationProviding nutrition education. |
| Control group | No intervention | –Without any intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ≥ 18 years old
- BMI of ≥ 22
Key exclusion criteria (2 listed)
- History of critical illness
- Having been diagnosed with at least one endocrine disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition educationDietitians visited the worksites of the intervention group once a week to deliver a nutrition education session and provide dietary advice for each participant. | Behavioural | Intervention group |
Primary outcome
BMI
Time frame: After 8 week intervention
To evaluate the effect of nutrition education on the reduction of BMI (body mass index).
Waist circumference
Time frame: After 8 week intervention
One of the metabolic syndrome factors.
Systolic blood pressure
Time frame: After 8 week intervention
One of the metabolic syndrome factors.
Diastolic blood pressure
Time frame: After 8 week intervention
One of the metabolic syndrome factors.
Fasting blood sugar
Time frame: After 8 week intervention
One of the metabolic syndrome factors.
Serum triglyceride
Time frame: After 8 week intervention
One of the metabolic syndrome factors.
Serum high density lipoprotein cholesterol
Time frame: After 8 week intervention
One of the metabolic syndrome factors.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition education in people with Metabolic Syndrome and Health Education, run by Lotung Poh-Ai Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI (time frame: After 8 week intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2020.