- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01738061
A Multidimensional Lifestyle Intervention to Reduce the Risk of Metabolic Disorders in Older Workers in Taiwan
November 29, 2012 updated by: Alan C. Tsai, Ph. D., Asia University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
108
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- full-time worker
- aged 50 years or older
- willing to complete a screening questionnaire
- sign a study consent
Exclusion Criteria:
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: reference group
They continued their daily routine.
|
|
Experimental: Multidimensional lifestyle intervention
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
At baseline (week 0) and endpoint (week 24) of the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lifestyle factors
Time Frame: At baseline (week 0) and endpoint (week 24) of the intervention
|
Physical activity, food consumption frequency and self-reported sleep and sedentary hours.
|
At baseline (week 0) and endpoint (week 24) of the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Alan C Tsai, PhD, Department of Healthcare Administration, Asia University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
October 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
November 28, 2012
First Submitted That Met QC Criteria
November 29, 2012
First Posted (Estimate)
November 30, 2012
Study Record Updates
Last Update Posted (Estimate)
November 30, 2012
Last Update Submitted That Met QC Criteria
November 29, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MM-WHP-99
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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