Promoting Physical Activity and Break in Office Workers

June 1, 2017 updated by: Chutima Jalayondeja, Mahidol University

Survey and Promoting Physical Activity in Employees and Entrepreneurial Projects of Software Park Thailand Under the Office of Science and Technology (NSTDA.)

This study will determine the effect of physical activity promotion based on Thai Physical Activity Guideline (TPAG) and break in workplace sitting on physical activity level, physical fitness, body compositions, cognitive functions and cardiometabolic biomarkers in office workers at Software Park Thailand under the Office of Science and Technology (NSTDA). There are two intervention including physical activity (PA) coaching based on TPAG and break in workplace sitting. The investigators will coach participants for promoting daily active life and participating to monthly exercise programs. The participants will be assign to break in sitting during daily work.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Objective: this study will determine the effect of physical activity promotion based on Thai Physical Activity Guideline (TPAG) and break in workplace sitting on physical activity level, physical fitness, body compositions, cognitive functions and cardiometabolic biomarkers in office workers at Software Park Thailand under the Office of Science and Technology (NSTDA).

Study design: an experimental study Interventions: there are two intervention including physical activity (PA) coaching based on TPAG and break in workplace sitting. We coach them for promoting daily active life and participating to monthly exercise programs. They will assign to break in sitting during daily work.

Methods: The office workers at Software Park Thailand under the Office of Science and Technology (NSTDA) will be invited to participate in this study. The participants are a convenience sample. The inclusion criteria are: a) age 20-60 years, b) body mass index (BMI) ≤23, c) sitting for work more than 8 hours/day, and d) physical inactivity according to the PA recommendation of the World Health Organization (WHO). The participants will be divided into three groups as the following.

Experiment 1: 30 subjects will receive PA coaching based on TPAG and long break or break 15 minutes for every 2 hours (TPAG with LB) Experiment 2: 30 subjects will receive PA coaching based on TPAG and short break or break 1-2 minutes for every 1 hours (TPAG with SB) Control group: 30 subjects will not receive interventions (control). Demographics are measured by the online self-reported questionnaire. The participants will be assessed physical activity level, physical fitness, body compositions, cognitive function and cardiometabolic biomarkers at baseline, 2-and 6-month after intervention. PA level is measured by the questionnaires and the 6-step ladder of TPAG for PA promotion. Physical fitness includes muscles strength and endurance, range of motion (ROM) and the 3-minute step test measured by the non invasive hemodynamic monitors. Body compositions comprise of BMI, waist circumference, waist to height ratio and body fat measured by the Bioelectrical Impedance Analysis. Cognitions comprise of stroop color and word test, verbal fluency, digit span test and simple reaction time test. The blood test is used to detect the cardiometabolic biomarkers such as fasting blood glucose, glycated hemoglobin (HbA1c), HDL, LDL and total cholesterol.

Statistical analysis: The statistical package for social sciences (SPSS) version 21.0 will be used for data analysis. Two-way mixed model will be used for determining the effect of PA promotion based on TPAG and break in workplace sitting on health outcomes among office workers.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Thailand
    • Nakon Prothom
      • Salaya, Nakon Prothom, Thailand, 73170
        • Recruiting
        • Mahidol University
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Works related to computer or office workers who works more than 2 years
  • BMI more than 23
  • Have a sedentary lifestyle or insufficient physical activity (level 0-1 evaluate by 6-stairs of Thailand Physical Activity Guideline)
  • Thai people who have a good communication skill in the Thai language

Exclusion Criteria:

  • Have a communication or cognition problem evaluate by Thai Mental Stat Examination
  • Have a body disability
  • Doctor advice don't exercise or have a fail result from Physical Activity Readiness Questionnaire
  • Have a pain evaluate by Numeric Rating Scale more than 5

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Control
No intervention
Other: Control
No intervention
Experimental: TPAG with long break
PA coaching based on TPAG and long break or break 15 minutes for every 2 hours (TPAG with LB)
Behavioral: TPAG with long break
PA coaching based on Thai Physical Activity Guideline (TPAG) and long break or break 15 minutes for every 2 hours (TPAG with LB)
Experimental: TPAG with short break
PA coaching based on TPAG and short break or break 1-2 minutes for every 1 hours (TPAG with SB)
Behavioral: TPAG with short break
PA coaching based on TPAG and short break or break 1-2 minutes for every 1 hours (TPAG with SB)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change fasting blood glucose
Time Frame: Change from baseline blood glucose at 6 months
Blood sample test to measure fasting blood glucose (mg/dL)
Change from baseline blood glucose at 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change physical activity
Time Frame: Change from baseline physical activity at 6 months
Questionnaire to measure physical activity (kcal/week)
Change from baseline physical activity at 6 months
Change cholesterol
Time Frame: Change from baseline HDL cholesterol at 6 months
Blood sample test to measure HDL cholesterol (mg/dL)
Change from baseline HDL cholesterol at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mahidol University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chutima Jalayondeja, Dr.P.H., Faculty of Physical Therapy, Mahidol University, Thailand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 5, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MU-CIRB 2016/052.0804

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data will be made available for other researchers after the end of the study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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