Physical ActivityNCT03163953
Promoting Physical Activity and Break in Office Workers
A study testing TPAG with long break and TPAG with short break in people with Physical Activity and Sedentary Lifestyle, run by Mahidol University at 1 site in Thailand.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Sedentary Lifestyle
- What is being tested?
- TPAG with long break and TPAG with short break
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteThailand
- Study dates
- 5 Jun 2017to 28 Feb 2018
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Mahidol University
Salaya, Nakon Prothom, 73170
Chutima Jalayondeja, Dr. P.H., (66)24415450 ext. 20801, chutimajala@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Physical Activity, Sedentary Lifestyle
- Being tested
- TPAG with long break, TPAG with short break, Control
- Keywords
- Physical Activity, Sedentary Lifestyle, Office Workers
- Medical subject headings
- Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPAG with long breakBehavioural
PA coaching based on Thai Physical Activity Guideline (TPAG) and long break or break 15 minutes for every 2 hours (TPAG with LB)
TPAG with short breakBehavioural
PA coaching based on TPAG and short break or break 1-2 minutes for every 1 hours (TPAG with SB)
ControlOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| TPAG with long break | Experimental | PA coaching based on TPAG and long break or break 15 minutes for every 2 hours (TPAG with LB) Receives: Behavioral: TPAG with long break |
| TPAG with short break | Experimental | PA coaching based on TPAG and short break or break 1-2 minutes for every 1 hours (TPAG with SB) Receives: Behavioral: TPAG with short break |
| Control | Other | No intervention Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change fasting blood glucose
Blood sample test to measure fasting blood glucose (mg/dL)
Measured: Change from baseline blood glucose at 6 months
Secondary outcomes (2)
Change physical activity
Questionnaire to measure physical activity (kcal/week)
Measured: Change from baseline physical activity at 6 months
Change cholesterol
Blood sample test to measure HDL cholesterol (mg/dL)
Measured: Change from baseline HDL cholesterol at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start5 Jun 2017 (estimated)
- Primary completion30 Nov 2017 (estimated)
- Study completion28 Feb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chutima Jalayondeja, Mahidol University
- Investigators
- Chutima Jalayondeja, Dr.P.H., Principal investigator, Faculty of Physical Therapy, Mahidol University, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03163953
- Sponsor's protocol ID
- MU-CIRB 2016/052.0804
- Status last verified
- Jun 2017
- First submitted
- 11 May 2017
- Last updated
- 2 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be made available for other researchers after the end of the study.
Publications
Jalayondeja C, Jalayondeja W, Vachalathiti R, Bovonsunthonchai S, Sakulsriprasert P, Kaewkhuntee W, Bunprajun T, Upiriyasakul R. Cross-Cultural Adaptation of the Compendium of Physical Activity: Thai Translation and Content Validity. J Med Assoc Thai. 2015 Jun;98 Suppl 5:S53-9.
PubMed 26387412Ainsworth BE, Haskell WL, Herrmann SD, Meckes N, Bassett DR Jr, Tudor-Locke C, Greer JL, Vezina J, Whitt-Glover MC, Leon AS. 2011 Compendium of Physical Activities: a second update of codes and MET values. Med Sci Sports Exerc. 2011 Aug;43(8):1575-81. doi: 10.1249/MSS.0b013e31821ece12.
PubMed 21681120Jalayondeja C, Jalayondeja W, Mekhora K, Bhuanantanondh P, Dusadi-Isariyavong A, Upiriyasakul R. Break in Sedentary Behavior Reduces the Risk of Noncommunicable Diseases and Cardiometabolic Risk Factors among Workers in a Petroleum Company. Int J Environ Res Public Health. 2017 May 9;14(5):501. doi: 10.3390/ijerph14050501.
PubMed 28486414
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey and Promoting Physical Activity in Employees and Entrepreneurial Projects of Software Park Thailand Under the Office of Science and Technology (NSTDA.)
- ClinicalTrials.gov ID
- NCT03163953
- Acronym / sponsor ID
- MU-CIRB 2016/052.0804
- Conditions
- Physical Activity, Sedentary Lifestyle
- Keywords
- Physical Activity, Sedentary Lifestyle, Office Workers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 5 Jun 2017 (estimated)
- Primary completion
- 30 Nov 2017 (estimated)
- Study completion
- 28 Feb 2018 (estimated)
- First posted
- 23 May 2017 (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 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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TPAG with long break | Experimental | Behavioral: TPAG with long breakPA coaching based on TPAG and long break or break 15 minutes for every 2 hours (TPAG with LB) |
| TPAG with short break | Experimental | Behavioral: TPAG with short breakPA coaching based on TPAG and short break or break 1-2 minutes for every 1 hours (TPAG with SB) |
| Control | Other | Other: ControlNo intervention |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| TPAG with long breakPA coaching based on Thai Physical Activity Guideline (TPAG) and long break or break 15 minutes for every 2 hours (TPAG with LB) | Behavioural | TPAG with long break |
| TPAG with short breakPA coaching based on TPAG and short break or break 1-2 minutes for every 1 hours (TPAG with SB) | Behavioural | TPAG with short break |
| ControlNo intervention | Other | Control |
Primary outcome
Change fasting blood glucose
Time frame: Change from baseline blood glucose at 6 months
Blood sample test to measure fasting blood glucose (mg/dL)
2 secondary outcomes
Change physical activity
Time frame: Change from baseline physical activity at 6 months
Change cholesterol
Time frame: Change from baseline HDL cholesterol at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
- Results publication: PubMed 26387412Jalayondeja C, Jalayondeja W, Vachalathiti R, Bovonsunthonchai S, Sakulsriprasert P, Kaewkhuntee W, Bunprajun T, Upiriyasakul R. Cross-Cultural Adaptation of the Compendium of Physical Activity: Thai Translation and Content Validity. J Med Assoc Thai. 2015 Jun;98 Suppl 5:S53-9.
- Results publication: PubMed 21681120Ainsworth BE, Haskell WL, Herrmann SD, Meckes N, Bassett DR Jr, Tudor-Locke C, Greer JL, Vezina J, Whitt-Glover MC, Leon AS. 2011 Compendium of Physical Activities: a second update of codes and MET values. Med Sci Sports Exerc. 2011 Aug;43(8):1575-81. doi: 10.1249/MSS.0b013e31821ece12.
- Results publication: PubMed 28486414Jalayondeja C, Jalayondeja W, Mekhora K, Bhuanantanondh P, Dusadi-Isariyavong A, Upiriyasakul R. Break in Sedentary Behavior Reduces the Risk of Noncommunicable Diseases and Cardiometabolic Risk Factors among Workers in a Petroleum Company. Int J Environ Res Public Health. 2017 May 9;14(5):501. doi: 10.3390/ijerph14050501.
- Individual participant dataSharing planned: Yes. All data will be made available for other researchers after the end of the study.
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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.
Chutima Jalayondeja, Dr.P.H. principal investigator
Faculty of Physical Therapy, Mahidol University, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TPAG with long break and TPAG with short break in people with Physical Activity and Sedentary Lifestyle, run by Mahidol University at 1 site in Thailand.
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 4 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: status not confirmed, as of the sponsor's last update on 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chutima Jalayondeja, Dr.P.H. ((66)2-441-5450 ext. 21806, chutimajala@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change fasting blood glucose (time frame: Change from baseline blood glucose at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03163953, which also lists 3 linked publications.
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 2 Jun 2017.