Cardiovascular Risk FactorNCT04403789
Effects of a Workplace Exercise Intervention on Cardio-Metabolic Health
A study testing Exercise Time and Supervised Group Exercise in people with Cardiovascular Risk Factor and Pre Diabetes, run by United Arab Emirates University at 1 site in United Arab Emirates.
Trial summary
Background: The rising levels of physical inactivity in the Eastern Mediterranean region (43.2%) and in the United Arab Emirates (38%) compared with the global levels of physical inactivity (31.2%) is alarming (6,15). Therefore, action is required to reduce physical inactivity using evidence-based strategies. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor, Pre Diabetes, High Blood Pressure
- What is being tested?
- Exercise Time and Supervised Group Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 28 Mar 2021to 30 Nov 2021
- 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 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant must be an employee in the company and have at least a waist circumference of ≥94 cm (≥90 cm for South and East Asians) for males and ≥ 80 cm for females.
- Aged 18 to 59 years old.
- Availability of the participants for the study duration.
- Participant is willing to commit to the intervention until the end.
- Signed written consent to participate.
Who cannot join
- Severe injury in the joints or the back or any medical condition that would prevent them from exercising, or the participant is advised not to exercise by a doctor.
- Pregnant.
- Any planned major surgical procedures during the intervention period.
- Self-reported cardiovascular disease, lung disease, or cancer.
- Currently participating in a health promotion program
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
Emirates Integrated Telecommunication Company (Du), Headquarters Building.
Dubai, Dubai Internet City
About this study
Official title: Effects of a Workplace Exercise Intervention on Cardio-Metabolic Health: Randomized Controlled Trial
Background: The rising levels of physical inactivity in the Eastern Mediterranean region (43.2%) and in the United Arab Emirates (38%) compared with the global levels of physical inactivity (31.2%) is alarming (6,15). Therefore, action is required to reduce physical inactivity using evidence-based strategies. This study aims to provide scientific evidence that if the workplace environment promotes behavior change, physical activity levels could increase and, therefore, improve health. Objective: Primary objective: to determine whether the workplace exercise intervention will improve the cardio-metabolic risk components for the employees. Secondary objective: to determine whether the workplace exercise intervention will improve physical activity levels even after 4 weeks of completing the intervention. Methods: A total of 150 participants will be recruited from a semi-government telecommunication company after meeting the eligibility criteria; 75 will be assigned to the intervention group and 75 to the delayed intervention group. Intervention: The Intervention group will receive 2 hours of exercise per week during working hours for 12 weeks. One hour can be used per day. The intervention group will be assigned to attend personal trainer sessions in the workplace gym during the intervention. After the intervention is completed the delayed intervention group will also receive 2 hours of exercise time per week from working hours for 4 weeks. Expected results: There is a statistically significant difference in the primary and secondary health outcome between the intervention group and delayed intervention group. Expected conclusion: Increasing exercise time in the workplace is associated with favorable cardio-metabolic risk profile.
Read the detailed description
Study Design The study is considered a parallel randomized controlled trial with a 1:1 allocation ratio to intervention group and delayed intervention group.
Recruitment An invitation to attend an informational session will be sent to the employees in the company's headquarter building in Dubai, United Arab Emirates. The invitation will emphasize that participation is voluntary and that participants can withdraw at any time without giving any reason. The informational session will discuss the study details (e.g. eligibility criteria) and some tips for physical activity. All employees who wish to participate will need to sign a consent form. The participants who are eligible will have to take an appointment in the workplace health center to make the required health measurements. A total of 150 participants will be recruited for the study. The eligibility of joining the workplace intervention will be based on the eligibility criteria listed below.
Setting and location The intervention will be conducted in the headquarter building of a semi-government telecommunication company in Dubai, United Arab Emirates. The headquarter building includes a gym and swimming pool. The intervention will use the gym workplace for conducting the exercise sessions.
Sample Size Previous studies concerning physical activity and cardiometabolic risk factors used 80% to 91% power and effect sizes ranging between 0.51 and 1.82 to find a significant difference between groups (8,10, 12-13). There are various reasons for choosing these articles for sample size calculations. For example, one article used a 12-week physical activity intervention and offered 3 sessions of physical activity per week (13). The same article included healthy adult participants (13). In addition, the cited articles were concerned with the effect of exercise on specific metabolic risk factors. These metabolic risk factors were waist circumference, systolic blood pressure. fasting glucose, lipid profiles (8,10, 12-13). More specifically, one article focused on waist circumference and physical activity (8). In contrast another article focused on systolic blood pressure and physical activity (10). For the present study, 124 participants will be required at 80% power. A further 20% more participants will be added because it is expected that participants might drop out during the intervention. Therefore, the investigators will recruit a total of 150 participants. The intervention group will have 75 participants and the delayed intervention group will have 75 participants.
Statistical Analysis Analyses and reporting will be in line with CONSORT guidelines, with all analyses being on an intention-to-treat principle regardless of intervention compliance. For a comparison between intervention and delayed intervention arms of the 12- weeks change in outcomes, the investigators plan to use analysis of covariance model, with baseline values as the covariate to control for chance imbalances at baseline. Age and sex specific interaction analyses will be conducted. In addition, the investigators will adopt a linear mixed model approach to provide the mean intervention effect, and quantification of individual differences in response to the intervention. The clinical significance of the intervention effect will be elaborated with magnitude-based inferences, confidence intervals, and confidence levels. Accepted regression modelling methods will be used to explore the intervention effects on the secondary objectives. Multiple imputation techniques will assess the sensitivity of the analyses to the missing at random assumption. Significance tests at 5%, either t-test or chi squared tests will be used to compare those with complete data and those who have missing outcomes. Finally, the investigators will develop a detailed coding scheme and coding checking protocol, cross tabulation, negative case analysis and respondent validation to enhance dependability and trustworthiness.
Evaluation
The completion of the tasks in the study will evaluate its success. For example:
Inviting all employees to the informational session and selecting eligible participants.
Randomly allocating participants to the intervention and delayed intervention group Collecting and analyzing blood samples pre and post the intervention period. Physical activity levels recorded through IPAQ and accelerometer. Recording participants attendance to personal trainer sessions. The evaluation of the intervention program will also depend on the primary and secondary health outcomes of the participants in the intervention and delayed intervention group. If there is a significant difference between the health outcomes of the two groups then the workplace intervention would have a positive effect.
Data Management The study investigators will ensure that the participants' anonymity is maintained. All data will be stored securely in an electronic database. Participants will be assigned a unique research number on the electronic database. No individually identifiable information will be included in the research database. The research number link to personal identifying information will be maintained in a secure server physically separate from the electronic database, which will be accessible only by specifically designated staff. This secure linkage will allow for the subsequent addition of new information to the research database, while maintaining no personal identifiers in the research database. Questionnaire responses and physical measures will be maintained under the unique research number.
Informed Consent The participant must personally sign and date (on paper or electronically) the latest approved version of the Informed Consent form before any study specific procedures are performed. Written versions of the Participant Information Leaflet and Informed Consent will be presented to the participants detailing no less than: the exact nature of the study; what it will involve for the participant; the implications and constraints of the protocol; the known side effects and any risks involved in taking part. It will be clearly stated that the participant is free to withdraw from the study at any time for any reason without prejudice to future care, and with no obligation to give the reason for withdrawal. The participant will be allowed as much time as wished to consider the information, and the opportunity to question the investigator or other independent parties to decide whether the participant will enroll in the study. Written Informed Consent will then be obtained by means of participant-dated signature and dated signature of the person who presented and obtained the Informed Consent. The person who obtained the consent must be suitably qualified and experienced, and have been authorized to do so by the Principal Investigator. A copy of the signed Informed Consent will be given to the participant.
Patient confidentiality and data security Patient names and identifying numbers (medical record number, Emirates Identification Card number etc.) will be removed from each record and replaced by a unique study number. It will not be possible for the researchers to identify the patients. Data will be held on the hard-drive of the researcher's computer in a locked office.
Discontinuation/Withdrawal of Participants from Study Each participant has the right to withdraw from the study at any time without giving any reason. Should a participant wish to withdraw from the study, they are advised in the participant information leaflet to contact the study coordinator. Should the participant wish for xx samples and data collected to be destroyed this will be done in a prompt and secure manner and a message will be sent to the person to confirm this. The reason for withdrawal, if given, will be recorded in the database.
Expenses and Benefits There is no plan to offer any monetary compensation to participants but if recruitment rates are lower than required, the investigators will pilot whether offering free (non-monetary) gifts, certificates, first aid kits, etc. improves response rates or not. For example, there will be one week where there are no gifts and another week where gifts are provided and see how that affects response rates.
Risks and Benefits Assessment The main risks of participation are direct physical harm and breaches of privacy/confidentiality. The risks of direct physical harm are minimal. All clinical staff will receive full training on all of the study procedures, and all measurements will be performed by trained staff/nurses. The exercise session will be conducted under supervision of certified personal trainers to ensure proper exercise techniques and therefore reduce risk of any potential injury. Participant's health information will be protected by restricted access and through use of de-identified labelling and use of de-identified data sets for analysis.
There are direct benefits to the individuals involved, together with the satisfaction of contributing to societal benefit by the increased understanding of role of exercise at workplace to improve health. The benefits of this study for science and society include but not limited to increase the investigators knowledge of the role of physical activity on overall health status, and risk factors for cardiovascular disease. The study aims to provide direction for prevention programs, particularly in the office workers/employees who are the key target group for interventions aiming to identify long lasting ways to increase participation in physical activity with potential health benefits.
- Being tested
- Exercise Time, Supervised Group Exercise
- Keywords
- cardiometabolic risk factors and exercise, workplace intervention
- Medical subject headings
- Glucose Intolerance, Hypertension, Hyperlipoproteinemia Type II, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TimeOther
Also called Working hours
Employees will be provided with exercise time of 2 hours per week. The 2 hours should be used in two days. The intervention duration is 12 weeks.
Supervised Group ExerciseBehavioural
Also called Group exercise sessions
The intervention group will receive 2-hours of exercise sessions per week under the supervision of a certified trainer in the gym workplace. The intervention duration is 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | During the intervention period they will receive 2 hours per week of group exercise sessions during working hours for 12 weeks. However, after the intervention period, there will be no change in working hours Receives: Other: Exercise Time; Behavioral: Supervised Group Exercise |
| Delayed Intervention Group (Control group) | Active comparator | During the intervention period there will be no change in working hours. However, after the intervention period they will receive 2 hours of exercise time during working hours per week for 4 weeks Receives: Other: Exercise Time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline high Blood Pressure (mmHg) at 12 Weeks
Primary objective: to determine whether the workplace exercise intervention will improve the cardio-metabolic risk components for the employees. The cardio-metabolic risk components compromises of several risk factors including, high blood pressure.
Measurement Criteria:
Systolic blood pressure ≥ 130 mm Hg OR Diastolic blood pressure ≥ 85 mm Hg
Measured: The outcome will be measured for both groups at baseline and after the 12-week intervention.
Change from Baseline Waist Circumference (centimetres) at 12 Weeks
Primary objective: to determine whether the workplace exercise intervention will improve the cardio-metabolic risk components for the employees. The cardio-metabolic risk components compromises of several risk factors including, waist circumference above normal range. The waist circumference criteria are:
Measurement Criteria:
1-Waist circumference above normal (cm): > 102 cm for males and > 88 cm for females (9)
Measured: The outcome will be measured for both groups at baseline and after the 12-week intervention.
Change from Baseline HDL-cholesterol (mmol/L) at 12 Weeks
Primary objective: to determine whether the workplace exercise intervention will improve the cardio-metabolic risk components for the employees. The cardio-metabolic risk components compromises of several risk factors including, elevated HDL-cholesterol.
Measurement Criteria:
< 40 mg/dL in males and < 50 mg/dL in females.
Measured: The outcome will be measured for both groups at baseline and after the 12-week intervention.
Change from Baseline Triglycerides (mg/dL) at 12 Weeks
Primary objective: to determine whether the workplace exercise intervention will improve the cardio-metabolic risk components for the employees. The cardio-metabolic risk components compromises of several risk factors including, Elevated Triglycerides (mg/dL)
Measurement Criteria:
- Elevated Triglycerides ≥ 150 (mg/dL)
Measured: The outcome will be measured for both groups at baseline and after the 12-week intervention.
Change from Baseline Fasting Plasma Glucose (mmol/L) at 12 Weeks
Primary objective: to determine whether the workplace exercise intervention will improve the cardio-metabolic risk components for the employees. The cardio-metabolic risk components compromises of several risk factors including, pre-diabetes (Fasting plasma glucose).
Measurement Criteria:
1-Pre-diabetes: Fasting plasma glucose (mg/dL) ≥ 100 mg/dL
Measured: The outcome will be measured for both groups at baseline and after the 12-week intervention.
Secondary outcomes (2)
Change from Baseline Physical Activity (IPAQ Questionnaire) at 12 Weeks and 16 weeks
Secondary objective:To determine whether the workplace exercise intervention will improve physical activity levels after 4 weeks of completing the intervention. Two measurement criteria will be used to measure physical activity in this study. One of these measurements is the International Physical Activity Questionnaire (IPAQ). This measurement classifies participants into three categories based on the answers provided:
- Low physical activity
- Moderate physical activity
- High physical activity (7)
Measured: This outcome will be measured for both groups at baseline, at 12-week intervention. The third measurement will be at 16 weeks (4 weeks after completing the intervention, for the intervention group only).
Change from Baseline Physical Activity (AX3 Device) at 12 Weeks and 16 weeks
Secondary objective: To determine whether the workplace exercise intervention will improve physical activity levels after 4 weeks of completing the intervention. Two measurement criteria will be used to measure physical activity in this study. One of these measurements is the AX3 (3-Axis Logging Accelerometer). The accelerometer devices will be configured to capture three-dimensional acceleration at 100 Hz with a dynamic range of ±8 g.
Measured: This outcome will be measured for both groups at baseline, at 12-week intervention. The third measurement will be at 16 weeks (4 weeks after completing the intervention, for the intervention group only).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start28 Mar 2021
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention The intervention duration is 12 weeks and it will provide the employees exercise time of 2 hours per week. The 2 hours should be used in two days either at the middle or at the end of working hours. The 2-hours exercise session will be conducted under the supervision of a certified trainer in the gym workplace. The 12 weeks period was chosen based on recommendations from previous studies to examine the effect of exercise interventions. The delayed intervention group will be asked to perform their usual routine and continue their usual exercise/physical activity routines. However, after the intervention is completed the delayed intervention group will also receive 2 hours of exercise time per week from working hours for 4 weeks. The reason for this is to encourage participants to participate in the study regardless of which group they will be assigned in. Also, this will help us reduce contamination as participants will not be aware which group they were assigned in.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Arab Emirates University
- Sponsor type
- University, hospital or other
- Collaborators
- Mohammed Bin Rashid University of Medicine and Health Sciences
- Responsible party
- Principal investigator, Dr. Javaid Nauman, United Arab Emirates University
- Investigators
- Javaid Nauman, PhD, Principal investigator, United Arab Emirates University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04403789
- Sponsor's protocol ID
- 23081010
- Status last verified
- May 2022
- First submitted
- 6 May 2020
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to publish the study protocol. The data will be available if approval from Dubai Scientific Research Ethics Committee in Dubai Health Authority is acquired.
Publications
Axivity Ltd. AX3 [Internet]. AX3. 2019 [cited 2019 Jun 16]. Available from: http://www.axivity.com/product/1
Bergman F, Wahlstrom V, Stomby A, Otten J, Lanthen E, Renklint R, Waling M, Sorlin A, Boraxbekk CJ, Wennberg P, Ohberg F, Levine JA, Olsson T. Treadmill workstations in office workers who are overweight or obese: a randomised controlled trial. Lancet Public Health. 2018 Nov;3(11):e523-e535. doi: 10.1016/S2468-2667(18)30163-4. Epub 2018 Oct 12.
PubMed 30322782Cannon CP. Cardiovascular disease and modifiable cardiometabolic risk factors. Clin Cornerstone. 2007;8(3):11-28. doi: 10.1016/s1098-3597(07)80025-1.
PubMed 18452839Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, Braun LT, de Ferranti S, Faiella-Tommasino J, Forman DE, Goldberg R, Heidenreich PA, Hlatky MA, Jones DW, Lloyd-Jones D, Lopez-Pajares N, Ndumele CE, Orringer CE, Peralta CA, Saseen JJ, Smith SC Jr, Sperling L, Virani SS, Yeboah J. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Jun 18;139(25):e1082-e1143. doi: 10.1161/CIR.0000000000000625. Epub 2018 Nov 10.
PubMed 30586774Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, Braun LT, de Ferranti S, Faiella-Tommasino J, Forman DE, Goldberg R, Heidenreich PA, Hlatky MA, Jones DW, Lloyd-Jones D, Lopez-Pajares N, Ndumele CE, Orringer CE, Peralta CA, Saseen JJ, Smith SC Jr, Sperling L, Virani SS, Yeboah J. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Jun 18;139(25):e1046-e1081. doi: 10.1161/CIR.0000000000000624. Epub 2018 Nov 10. No abstract available.
PubMed 30565953Guthold R, Stevens GA, Riley LM, Bull FC. Worldwide trends in insufficient physical activity from 2001 to 2016: a pooled analysis of 358 population-based surveys with 1.9 million participants. Lancet Glob Health. 2018 Oct;6(10):e1077-e1086. doi: 10.1016/S2214-109X(18)30357-7. Epub 2018 Sep 4.
PubMed 30193830International Physical Activity Questionnaire. IPAQ scoring protocol - International Physical Activity Questionnaire [Internet]. 2005 [cited 2019 Jan 27]. Available from: https://sites.google.com/site/theipaq/scoring-protocol
Irving BA, Davis CK, Brock DW, Weltman JY, Swift D, Barrett EJ, Gaesser GA, Weltman A. Effect of exercise training intensity on abdominal visceral fat and body composition. Med Sci Sports Exerc. 2008 Nov;40(11):1863-72. doi: 10.1249/MSS.0b013e3181801d40.
PubMed 18845966Klein S, Allison DB, Heymsfield SB, Kelley DE, Leibel RL, Nonas C, Kahn R; Association for Weight Management and Obesity Prevention; NAASO; Obesity Society; American Society for Nutrition; American Diabetes Association. Waist circumference and cardiometabolic risk: a consensus statement from shaping America's health: Association for Weight Management and Obesity Prevention; NAASO, the Obesity Society; the American Society for Nutrition; and the American Diabetes Association. Diabetes Care. 2007 Jun;30(6):1647-52. doi: 10.2337/dc07-9921. Epub 2007 Mar 14. No abstract available.
PubMed 17360974Molmen-Hansen HE, Stolen T, Tjonna AE, Aamot IL, Ekeberg IS, Tyldum GA, Wisloff U, Ingul CB, Stoylen A. Aerobic interval training reduces blood pressure and improves myocardial function in hypertensive patients. Eur J Prev Cardiol. 2012 Apr;19(2):151-60. doi: 10.1177/1741826711400512. Epub 2011 Mar 4.
PubMed 21450580Nichols GA, Horberg M, Koebnick C, Young DR, Waitzfelder B, Sherwood NE, Daley MF, Ferrara A. Cardiometabolic Risk Factors Among 1.3 Million Adults With Overweight or Obesity, but Not Diabetes, in 10 Geographically Diverse Regions of the United States, 2012-2013. Prev Chronic Dis. 2017 Mar 9;14:E22. doi: 10.5888/pcd14.160438.
PubMed 28278130Tomeleri CM, Ribeiro AS, Souza MF, Schiavoni D, Schoenfeld BJ, Venturini D, Barbosa DS, Landucci K, Sardinha LB, Cyrino ES. Resistance training improves inflammatory level, lipid and glycemic profiles in obese older women: A randomized controlled trial. Exp Gerontol. 2016 Nov;84:80-87. doi: 10.1016/j.exger.2016.09.005. Epub 2016 Sep 9.
PubMed 27616162Tomeleri CM, Souza MF, Burini RC, Cavaglieri CR, Ribeiro AS, Antunes M, Nunes JP, Venturini D, Barbosa DS, Sardinha LB, Cyrino ES. Resistance training reduces metabolic syndrome and inflammatory markers in older women: A randomized controlled trial. J Diabetes. 2018 Apr;10(4):328-337. doi: 10.1111/1753-0407.12614. Epub 2017 Dec 11.
PubMed 29031002WHO. WHO | Waist circumference and waist-hip ratio [Internet]. WHO. 2008 [cited 2018 Dec 12]. Available from: http://www.who.int/nutrition/publications/obesity/WHO_report_waistcircumference_and_waisthip_ratio/en/
WHO. United Arab Emirates health profile 2015 [Internet]. 2016. Available from: http://applications.emro.who.int/dsaf/EMROPUB_2016_EN_19276.pdf
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Workplace Exercise Intervention on Cardio-Metabolic Health: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04403789
- Acronym / sponsor ID
- 23081010
- Keywords
- cardiometabolic risk factors and exercise, workplace intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- United Arab Emirates UniversityUniversity, hospital or other
- Collaborators
- Mohammed Bin Rashid University of Medicine and Health Sciences
- Study start
- 28 Mar 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 27 May 2020 (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.
Background: The rising levels of physical inactivity in the Eastern Mediterranean region (43.2%) and in the United Arab Emirates (38%) compared with the global levels of physical inactivity (31.2%) is alarming (6,15). Therefore, action is required to reduce physical inactivity using evidence-based strategies. This study aims to provide scientific evidence that if the workplace environment promotes behavior change, physical activity levels could increase and, therefore, improve health. Objective: Primary objective: to determine whether the workplace exercise intervention will improve the cardio-metabolic risk components for the employees. Secondary objective: to determine whether the workplace exercise intervention will improve physical activity levels even after 4 weeks of completing the intervention. Methods: A total of 150 participants will be recruited from a semi-government telecommunication company after meeting the eligibility criteria; 75 will be assigned to the intervention group and 75 to the delayed intervention group. Intervention: The Intervention group will receive 2 hours of exercise per week during working hours for 12 weeks. One hour can be used per day. The intervention group will be assigned to attend personal trainer sessions in the workplace gym during the intervention. After the intervention is completed the delayed intervention group will also receive 2 hours of exercise time per week from working hours for 4 weeks. Expected results: There is a statistically significant difference in the primary and secondary health outcome between the intervention group and delayed intervention group. Expected conclusion: Increasing exercise time in the workplace is associated with favorable cardio-metabolic risk profile.
Detailed description
Study Design The study is considered a parallel randomized controlled trial with a 1:1 allocation ratio to intervention group and delayed intervention group.
Recruitment An invitation to attend an informational session will be sent to the employees in the company's headquarter building in Dubai, United Arab Emirates. The invitation will emphasize that participation is voluntary and that participants can withdraw at any time without giving any reason. The informational session will discuss the study details (e.g. eligibility criteria) and some tips for physical activity. All employees who wish to participate will need to sign a consent form. The participants who are eligible will have to take an appointment in the workplace health center to make the required health measurements. A total of 150 participants will be recruited for the study. The eligibility of joining the workplace intervention will be based on the eligibility criteria listed below.
Setting and location The intervention will be conducted in the headquarter building of a semi-government telecommunication company in Dubai, United Arab Emirates. The headquarter building includes a gym and swimming pool. The intervention will use the gym workplace for conducting the exercise sessions.
Sample Size Previous studies concerning physical activity and cardiometabolic risk factors used 80% to 91% power and effect sizes ranging between 0.51 and 1.82 to find a significant difference between groups (8,10, 12-13). There are various reasons for choosing these articles for sample size calculations. For example, one article used a 12-week physical activity intervention and offered 3 sessions of physical activity per week (13). The same article included healthy adult participants (13). In addition, the cited articles were concerned with the effect of exercise on specific metabolic risk factors. These metabolic risk factors were waist circumference, systolic blood pressure. fasting glucose, lipid profiles (8,10, 12-13). More specifically, one article focused on waist circumference and physical activity (8). In contrast another article focused on systolic blood pressure and physical activity (10). For the present study, 124 participants will be required at 80% power. A further 20% more participants will be added because it is expected that participants might drop out during the intervention. Therefore, the investigators will recruit a total of 150 participants. The intervention group will have 75 participants and the delayed intervention group will have 75 participants.
Statistical Analysis Analyses and reporting will be in line with CONSORT guidelines, with all analyses being on an intention-to-treat principle regardless of intervention compliance. For a comparison between intervention and delayed intervention arms of the 12- weeks change in outcomes, the investigators plan to use analysis of covariance model, with baseline values as the covariate to control for chance imbalances at baseline. Age and sex specific interaction analyses will be conducted. In addition, the investigators will adopt a linear mixed model approach to provide the mean intervention effect, and quantification of individual differences in response to the intervention. The clinical significance of the intervention effect will be elaborated with magnitude-based inferences, confidence intervals, and confidence levels. Accepted regression modelling methods will be used to explore the intervention effects on the secondary objectives. Multiple imputation techniques will assess the sensitivity of the analyses to the missing at random assumption. Significance tests at 5%, either t-test or chi squared tests will be used to compare those with complete data and those who have missing outcomes. Finally, the investigators will develop a detailed coding scheme and coding checking protocol, cross tabulation, negative case analysis and respondent validation to enhance dependability and trustworthiness.
Evaluation
The completion of the tasks in the study will evaluate its success. For example:
Inviting all employees to the informational session and selecting eligible participants.
Randomly allocating participants to the intervention and delayed intervention group Collecting and analyzing blood samples pre and post the intervention period. Physical activity levels recorded through IPAQ and accelerometer. Recording participants attendance to personal trainer sessions. The evaluation of the intervention program will also depend on the primary and secondary health outcomes of the participants in the intervention and delayed intervention group. If there is a significant difference between the health outcomes of the two groups then the workplace intervention would have a positive effect.
Data Management The study investigators will ensure that the participants' anonymity is maintained. All data will be stored securely in an electronic database. Participants will be assigned a unique research number on the electronic database. No individually identifiable information will be included in the research database. The research number link to personal identifying information will be maintained in a secure server physically separate from the electronic database, which will be accessible only by specifically designated staff. This secure linkage will allow for the subsequent addition of new information to the research database, while maintaining no personal identifiers in the research database. Questionnaire responses and physical measures will be maintained under the unique research number.
Informed Consent The participant must personally sign and date (on paper or electronically) the latest approved version of the Informed Consent form before any study specific procedures are performed. Written versions of the Participant Information Leaflet and Informed Consent will be presented to the participants detailing no less than: the exact nature of the study; what it will involve for the participant; the implications and constraints of the protocol; the known side effects and any risks involved in taking part. It will be clearly stated that the participant is free to withdraw from the study at any time for any reason without prejudice to future care, and with no obligation to give the reason for withdrawal. The participant will be allowed as much time as wished to consider the information, and the opportunity to question the investigator or other independent parties to decide whether the participant will enroll in the study. Written Informed Consent will then be obtained by means of participant-dated signature and dated signature of the person who presented and obtained the Informed Consent. The person who obtained the consent must be suitably qualified and experienced, and have been authorized to do so by the Principal Investigator. A copy of the signed Informed Consent will be given to the participant.
Patient confidentiality and data security Patient names and identifying numbers (medical record number, Emirates Identification Card number etc.) will be removed from each record and replaced by a unique study number. It will not be possible for the researchers to identify the patients. Data will be held on the hard-drive of the researcher's computer in a locked office.
Discontinuation/Withdrawal of Participants from Study Each participant has the right to withdraw from the study at any time without giving any reason. Should a participant wish to withdraw from the study, they are advised in the participant information leaflet to contact the study coordinator. Should the participant wish for xx samples and data collected to be destroyed this will be done in a prompt and secure manner and a message will be sent to the person to confirm this. The reason for withdrawal, if given, will be recorded in the database.
Expenses and Benefits There is no plan to offer any monetary compensation to participants but if recruitment rates are lower than required, the investigators will pilot whether offering free (non-monetary) gifts, certificates, first aid kits, etc. improves response rates or not. For example, there will be one week where there are no gifts and another week where gifts are provided and see how that affects response rates.
Risks and Benefits Assessment The main risks of participation are direct physical harm and breaches of privacy/confidentiality. The risks of direct physical harm are minimal. All clinical staff will receive full training on all of the study procedures, and all measurements will be performed by trained staff/nurses. The exercise session will be conducted under supervision of certified personal trainers to ensure proper exercise techniques and therefore reduce risk of any potential injury. Participant's health information will be protected by restricted access and through use of de-identified labelling and use of de-identified data sets for analysis.
There are direct benefits to the individuals involved, together with the satisfaction of contributing to societal benefit by the increased understanding of role of exercise at workplace to improve health. The benefits of this study for science and society include but not limited to increase the investigators knowledge of the role of physical activity on overall health status, and risk factors for cardiovascular disease. The study aims to provide direction for prevention programs, particularly in the office workers/employees who are the key target group for interventions aiming to identify long lasting ways to increase participation in physical activity with potential health benefits.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Intervention The intervention duration is 12 weeks and it will provide the employees exercise time of 2 hours per week. The 2 hours should be used in two days either at the middle or at the end of working hours. The 2-hours exercise session will be conducted under the supervision of a certified trainer in the gym workplace. The 12 weeks period was chosen based on recommendations from previous studies to examine the effect of exercise interventions. The delayed intervention group will be asked to perform their usual routine and continue their usual exercise/physical activity routines. However, after the intervention is completed the delayed intervention group will also receive 2 hours of exercise time per week from working hours for 4 weeks. The reason for this is to encourage participants to participate in the study regardless of which group they will be assigned in. Also, this will help us reduce contamination as participants will not be aware which group they were assigned in.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Exercise Time, Behavioral: Supervised Group ExerciseDuring the intervention period they will receive 2 hours per week of group exercise sessions during working hours for 12 weeks. However, after the intervention period, there will be no change in working hours |
| Delayed Intervention Group (Control group) | Active comparator | Other: Exercise TimeDuring the intervention period there will be no change in working hours. However, after the intervention period they will receive 2 hours of exercise time during working hours per week for 4 weeks |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participant must be an employee in the company and have at least a waist circumference of ≥94 cm (≥90 cm for South and East Asians) for males and ≥ 80 cm for females.
- Aged 18 to 59 years old.
- Availability of the participants for the study duration.
- Participant is willing to commit to the intervention until the end.
- Signed written consent to participate.
Key exclusion criteria (5 listed)
- Severe injury in the joints or the back or any medical condition that would prevent them from exercising, or the participant is advised not to exercise by a doctor.
- Pregnant.
- Any planned major surgical procedures during the intervention period.
- Self-reported cardiovascular disease, lung disease, or cancer.
- Currently participating in a health promotion program
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 |
|---|---|---|
| Exercise TimeAlso: Working hoursEmployees will be provided with exercise time of 2 hours per week. The 2 hours should be used in two days. The intervention duration is 12 weeks. | Other | Delayed Intervention Group (Control group), Intervention Group |
| Supervised Group ExerciseAlso: Group exercise sessionsThe intervention group will receive 2-hours of exercise sessions per week under the supervision of a certified trainer in the gym workplace. The intervention duration is 12 weeks. | Behavioural | Intervention Group |
Primary outcome
Change from Baseline high Blood Pressure (mmHg) at 12 Weeks
Time frame: The outcome will be measured for both groups at baseline and after the 12-week intervention.
Primary objective: to determine whether the workplace exercise intervention will improve the cardio-metabolic risk components for the employees. The cardio-metabolic risk components compromises of several risk factors including, high blood pressure. Measurement Criteria: Systolic blood pressure ≥ 130 mm Hg OR Diastolic blood pressure ≥ 85 mm Hg
Change from Baseline Waist Circumference (centimetres) at 12 Weeks
Time frame: The outcome will be measured for both groups at baseline and after the 12-week intervention.
Primary objective: to determine whether the workplace exercise intervention will improve the cardio-metabolic risk components for the employees. The cardio-metabolic risk components compromises of several risk factors including, waist circumference above normal range. The waist circumference criteria are: Measurement Criteria: 1-Waist circumference above normal (cm): > 102 cm for males and > 88 cm for females (9)
Change from Baseline HDL-cholesterol (mmol/L) at 12 Weeks
Time frame: The outcome will be measured for both groups at baseline and after the 12-week intervention.
Primary objective: to determine whether the workplace exercise intervention will improve the cardio-metabolic risk components for the employees. The cardio-metabolic risk components compromises of several risk factors including, elevated HDL-cholesterol. Measurement Criteria: < 40 mg/dL in males and < 50 mg/dL in females.
Change from Baseline Triglycerides (mg/dL) at 12 Weeks
Time frame: The outcome will be measured for both groups at baseline and after the 12-week intervention.
Primary objective: to determine whether the workplace exercise intervention will improve the cardio-metabolic risk components for the employees. The cardio-metabolic risk components compromises of several risk factors including, Elevated Triglycerides (mg/dL) Measurement Criteria: • Elevated Triglycerides ≥ 150 (mg/dL)
Change from Baseline Fasting Plasma Glucose (mmol/L) at 12 Weeks
Time frame: The outcome will be measured for both groups at baseline and after the 12-week intervention.
Primary objective: to determine whether the workplace exercise intervention will improve the cardio-metabolic risk components for the employees. The cardio-metabolic risk components compromises of several risk factors including, pre-diabetes (Fasting plasma glucose). Measurement Criteria: 1-Pre-diabetes: Fasting plasma glucose (mg/dL) ≥ 100 mg/dL
2 secondary outcomes
Change from Baseline Physical Activity (IPAQ Questionnaire) at 12 Weeks and 16 weeks
Time frame: This outcome will be measured for both groups at baseline, at 12-week intervention. The third measurement will be at 16 weeks (4 weeks after completing the intervention, for the intervention group only).
Change from Baseline Physical Activity (AX3 Device) at 12 Weeks and 16 weeks
Time frame: This outcome will be measured for both groups at baseline, at 12-week intervention. The third measurement will be at 16 weeks (4 weeks after completing the intervention, for the intervention group only).
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 24 May 2022.
- BackgroundAxivity Ltd. AX3 [Internet]. AX3. 2019 [cited 2019 Jun 16]. Available from: http://www.axivity.com/product/1
- Background: PubMed 30322782Bergman F, Wahlstrom V, Stomby A, Otten J, Lanthen E, Renklint R, Waling M, Sorlin A, Boraxbekk CJ, Wennberg P, Ohberg F, Levine JA, Olsson T. Treadmill workstations in office workers who are overweight or obese: a randomised controlled trial. Lancet Public Health. 2018 Nov;3(11):e523-e535. doi: 10.1016/S2468-2667(18)30163-4. Epub 2018 Oct 12.
- Background: PubMed 18452839Cannon CP. Cardiovascular disease and modifiable cardiometabolic risk factors. Clin Cornerstone. 2007;8(3):11-28. doi: 10.1016/s1098-3597(07)80025-1.
- Background: PubMed 30586774Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, Braun LT, de Ferranti S, Faiella-Tommasino J, Forman DE, Goldberg R, Heidenreich PA, Hlatky MA, Jones DW, Lloyd-Jones D, Lopez-Pajares N, Ndumele CE, Orringer CE, Peralta CA, Saseen JJ, Smith SC Jr, Sperling L, Virani SS, Yeboah J. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Jun 18;139(25):e1082-e1143. doi: 10.1161/CIR.0000000000000625. Epub 2018 Nov 10.
- Background: PubMed 30565953Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, Braun LT, de Ferranti S, Faiella-Tommasino J, Forman DE, Goldberg R, Heidenreich PA, Hlatky MA, Jones DW, Lloyd-Jones D, Lopez-Pajares N, Ndumele CE, Orringer CE, Peralta CA, Saseen JJ, Smith SC Jr, Sperling L, Virani SS, Yeboah J. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Jun 18;139(25):e1046-e1081. doi: 10.1161/CIR.0000000000000624. Epub 2018 Nov 10. No abstract available.
- Background: PubMed 30193830Guthold R, Stevens GA, Riley LM, Bull FC. Worldwide trends in insufficient physical activity from 2001 to 2016: a pooled analysis of 358 population-based surveys with 1.9 million participants. Lancet Glob Health. 2018 Oct;6(10):e1077-e1086. doi: 10.1016/S2214-109X(18)30357-7. Epub 2018 Sep 4.
- BackgroundInternational Physical Activity Questionnaire. IPAQ scoring protocol - International Physical Activity Questionnaire [Internet]. 2005 [cited 2019 Jan 27]. Available from: https://sites.google.com/site/theipaq/scoring-protocol
- Background: PubMed 18845966Irving BA, Davis CK, Brock DW, Weltman JY, Swift D, Barrett EJ, Gaesser GA, Weltman A. Effect of exercise training intensity on abdominal visceral fat and body composition. Med Sci Sports Exerc. 2008 Nov;40(11):1863-72. doi: 10.1249/MSS.0b013e3181801d40.
- Background: PubMed 17360974Klein S, Allison DB, Heymsfield SB, Kelley DE, Leibel RL, Nonas C, Kahn R; Association for Weight Management and Obesity Prevention; NAASO; Obesity Society; American Society for Nutrition; American Diabetes Association. Waist circumference and cardiometabolic risk: a consensus statement from shaping America's health: Association for Weight Management and Obesity Prevention; NAASO, the Obesity Society; the American Society for Nutrition; and the American Diabetes Association. Diabetes Care. 2007 Jun;30(6):1647-52. doi: 10.2337/dc07-9921. Epub 2007 Mar 14. No abstract available.
- Background: PubMed 21450580Molmen-Hansen HE, Stolen T, Tjonna AE, Aamot IL, Ekeberg IS, Tyldum GA, Wisloff U, Ingul CB, Stoylen A. Aerobic interval training reduces blood pressure and improves myocardial function in hypertensive patients. Eur J Prev Cardiol. 2012 Apr;19(2):151-60. doi: 10.1177/1741826711400512. Epub 2011 Mar 4.
- Background: PubMed 28278130Nichols GA, Horberg M, Koebnick C, Young DR, Waitzfelder B, Sherwood NE, Daley MF, Ferrara A. Cardiometabolic Risk Factors Among 1.3 Million Adults With Overweight or Obesity, but Not Diabetes, in 10 Geographically Diverse Regions of the United States, 2012-2013. Prev Chronic Dis. 2017 Mar 9;14:E22. doi: 10.5888/pcd14.160438.
- Background: PubMed 27616162Tomeleri CM, Ribeiro AS, Souza MF, Schiavoni D, Schoenfeld BJ, Venturini D, Barbosa DS, Landucci K, Sardinha LB, Cyrino ES. Resistance training improves inflammatory level, lipid and glycemic profiles in obese older women: A randomized controlled trial. Exp Gerontol. 2016 Nov;84:80-87. doi: 10.1016/j.exger.2016.09.005. Epub 2016 Sep 9.
- Individual participant dataSharing planned: Yes. There is a plan to publish the study protocol. The data will be available if approval from Dubai Scientific Research Ethics Committee in Dubai Health Authority is acquired.
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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.
Javaid Nauman, PhD principal investigator
United Arab Emirates University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Time and Supervised Group Exercise in people with Cardiovascular Risk Factor and Pre Diabetes, run by United Arab Emirates University at 1 site in United Arab Emirates.
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 5 inclusion and 5 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 24 May 2022. 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 United Arab Emirates. 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?
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?
Change from Baseline high Blood Pressure (mmHg) at 12 Weeks (time frame: The outcome will be measured for both groups at baseline and after the 12-week intervention.). The study lists 5 primary outcomes in all. 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 NCT04403789, which also lists 17 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 24 May 2022.