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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03163953
Other study ID # MU-CIRB 2016/052.0804
Secondary ID
Status Recruiting
Phase N/A
First received May 11, 2017
Last updated June 1, 2017
Start date June 5, 2017
Est. completion date February 28, 2018

Study information

Verified date June 2017
Source Mahidol University
Contact Chutima Jalayondeja, Dr.P.H.
Phone (66)2-441-5450
Email chutimajala@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date February 28, 2018
Est. primary completion date November 30, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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)
TPAG with short break
PA coaching based on TPAG and short break or break 1-2 minutes for every 1 hours (TPAG with SB)
Other:
Control
No intervention

Locations

Country Name City State
Thailand Mahidol University Salaya Nakon Prothom

Sponsors (1)

Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (3)

Ainsworth 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 — View Citation

Jalayondeja 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 — View Citation

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. 201 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change fasting blood glucose Blood sample test to measure fasting blood glucose (mg/dL) Change from baseline blood glucose at 6 months
Secondary Change physical activity Questionnaire to measure physical activity (kcal/week) Change from baseline physical activity at 6 months
Secondary Change cholesterol Blood sample test to measure HDL cholesterol (mg/dL) Change from baseline HDL cholesterol at 6 months
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