Metabolic DisorderNCT01738061
A Multidimensional Lifestyle Intervention to Reduce the Risk of Metabolic Disorders in Older Workers in Taiwan
A study testing Multidimensional lifestyle intervention in people with Metabolic Disorder, run by Asia University.
Trial summary
The study was aimed to evaluate the effectiveness of a multidimensional worksite intervention program to reduce the severity of metabolic disorders in older workers in Taiwan. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disorder
- What is being tested?
- Multidimensional lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Dec 2010
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- full-time worker
- aged 50 years or older
- willing to complete a screening questionnaire
- sign a study consent
Who cannot join
None listed.
About this study
The study was aimed to evaluate the effectiveness of a multidimensional worksite intervention program to reduce the severity of metabolic disorders in older workers in Taiwan.
Read the detailed description
The investigators conducted a quasi-experiment in older workers from three worksites in southern Taiwan.
- Qualified subjects were assigned to the intervention or the reference group according to their availability to take part in study activities.
- A researcher reviewed the health record and discussed with the subject about his/her health status.
- Subjects in the intervention group received lifestyle interventions. The activities included motivational presentations to increase awareness of own health problems and the role of lifestyle in the etiology of non-communicable chronic diseases.
- Subjects were organized into small groups to have biweekly meetings to share experiences, stimulate mutual encouragement and to overcome obstacles.
- Anthropometric and biochemical indicators were measured at baseline and endpoint (week 24).
- Conditions
- Metabolic Disorder
- Being tested
- Multidimensional lifestyle intervention
- Keywords
- Older workers, Multidimensional intervention, Worksite health promotion, Taiwan
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidimensional lifestyle interventionBehavioural
Lecture series to increase awareness of the relationship of lifestyle to chronic diseases Individualized review and discussion to understand own health problems Biweekly group meetings to stimulate motivation and exchange ideas
| Study group | Role | What they receive |
|---|---|---|
| reference group | No intervention | They continued their daily routine. |
| Multidimensional lifestyle intervention | Experimental | The multidimensional lifestyle intervention program received motivational activities to improve awareness of the impact of lifestyle on chronic diseases and the importance of self-health management. Receives: Behavioral: Multidimensional lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in anthropometric and srum biochemical indicators.
Body weight (BW), body height, waist circumference, Body mass index (BMI), arterial blood pressure (BP), serum total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG) and glycosylated hemoglobin (HbA1c) concentrations
Measured: At baseline (week 0) and endpoint (week 24) of the intervention
Secondary outcomes (1)
Lifestyle factors
Physical activity, food consumption frequency and self-reported sleep and sedentary hours.
Measured: At baseline (week 0) and endpoint (week 24) of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startJan 2010
- Primary completionOct 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DisorderStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asia University
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health, Executive Yuan, R.O.C. (Taiwan)
- Responsible party
- Principal investigator, Alan C. Tsai, Ph. D., Asia University
- Investigators
- Alan C Tsai, PhD, Principal investigator, Department of Healthcare Administration, Asia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738061
- Sponsor's protocol ID
- MM-WHP-99
- Status last verified
- Nov 2012
- First submitted
- 28 Nov 2012
- Last updated
- 30 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multidimensional Lifestyle Intervention to Reduce the Risk of Metabolic Disorders in Older Workers in Taiwan
- ClinicalTrials.gov ID
- NCT01738061
- Acronym / sponsor ID
- MM-WHP-99
- Conditions
- Metabolic Disorder
- Keywords
- Older workers, Multidimensional intervention, Worksite health promotion, Taiwan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Asia UniversityUniversity, hospital or other
- Collaborators
- Department of Health, Executive Yuan, R.O.C. (Taiwan)
- Study start
- Jan 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 30 Nov 2012 (estimated)
- 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.
The study was aimed to evaluate the effectiveness of a multidimensional worksite intervention program to reduce the severity of metabolic disorders in older workers in Taiwan.
Detailed description
The investigators conducted a quasi-experiment in older workers from three worksites in southern Taiwan.
- Qualified subjects were assigned to the intervention or the reference group according to their availability to take part in study activities.
- A researcher reviewed the health record and discussed with the subject about his/her health status.
- Subjects in the intervention group received lifestyle interventions. The activities included motivational presentations to increase awareness of own health problems and the role of lifestyle in the etiology of non-communicable chronic diseases.
- Subjects were organized into small groups to have biweekly meetings to share experiences, stimulate mutual encouragement and to overcome obstacles.
- Anthropometric and biochemical indicators were measured at baseline and endpoint (week 24).
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| reference group | No intervention | –They continued their daily routine. |
| Multidimensional lifestyle intervention | Experimental | Behavioral: Multidimensional lifestyle interventionThe multidimensional lifestyle intervention program received motivational activities to improve awareness of the impact of lifestyle on chronic diseases and the importance of self-health management. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- full-time worker
- aged 50 years or older
- willing to complete a screening questionnaire
- sign a study consent
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Multidimensional lifestyle interventionLecture series to increase awareness of the relationship of lifestyle to chronic diseases Individualized review and discussion to understand own health problems Biweekly group meetings to stimulate motivation and exchange ideas | Behavioural | Multidimensional lifestyle intervention |
Primary outcome
Changes in anthropometric and srum biochemical indicators.
Time frame: At baseline (week 0) and endpoint (week 24) of the intervention
Body weight (BW), body height, waist circumference, Body mass index (BMI), arterial blood pressure (BP), serum total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG) and glycosylated hemoglobin (HbA1c) concentrations
1 secondary outcome
Lifestyle factors
Time frame: At baseline (week 0) and endpoint (week 24) of the intervention
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 30 Nov 2012.
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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.
Alan C Tsai, PhD principal investigator
Department of Healthcare Administration, Asia University
Questions about this trial
What is this clinical trial studying?
A study testing Multidimensional lifestyle intervention in people with Metabolic Disorder, run by Asia University.
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 4 inclusion and 0 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 30 Nov 2012. 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?
Changes in anthropometric and srum biochemical indicators. (time frame: At baseline (week 0) and endpoint (week 24) of the intervention). 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 30 Nov 2012.