<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04403789</url>
  </required_header>
  <id_info>
    <org_study_id>23081010</org_study_id>
    <nct_id>NCT04403789</nct_id>
  </id_info>
  <brief_title>Effects of a Workplace Exercise Intervention on Cardio-Metabolic Health</brief_title>
  <official_title>Effects of a Workplace Exercise Intervention on Cardio-Metabolic Health: Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>United Arab Emirates University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mohammed Bin Rashid University of Medicine and Health Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>United Arab Emirates University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: The rising levels of physical inactivity in the Eastern Mediterranean region&#xD;
      (43.2%) and in the United Arab Emirates (38%) compared with the global levels of physical&#xD;
      inactivity (31.2%) is alarming (6,15). Therefore, action is required to reduce physical&#xD;
      inactivity using evidence-based strategies. This study aims to provide scientific evidence&#xD;
      that if the workplace environment promotes behavior change, physical activity levels could&#xD;
      increase and, therefore, improve health. Objective: Primary objective: to determine whether&#xD;
      the workplace exercise intervention will improve the cardio-metabolic risk components for the&#xD;
      employees. Secondary objective: to determine whether the workplace exercise intervention will&#xD;
      improve physical activity levels even after 4 weeks of completing the intervention. Methods:&#xD;
      A total of 150 participants will be recruited from a semi-government telecommunication&#xD;
      company after meeting the eligibility criteria; 75 will be assigned to the intervention group&#xD;
      and 75 to the delayed intervention group. Intervention: The Intervention group will receive 2&#xD;
      hours of exercise per week during working hours for 12 weeks. One hour can be used per day.&#xD;
      The intervention group will be assigned to attend personal trainer sessions in the workplace&#xD;
      gym during the intervention. After the intervention is completed the delayed intervention&#xD;
      group will also receive 2 hours of exercise time per week from working hours for 4 weeks.&#xD;
      Expected results: There is a statistically significant difference in the primary and&#xD;
      secondary health outcome between the intervention group and delayed intervention group.&#xD;
      Expected conclusion: Increasing exercise time in the workplace is associated with favorable&#xD;
      cardio-metabolic risk profile.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Design The study is considered a parallel randomized controlled trial with a 1:1&#xD;
      allocation ratio to intervention group and delayed intervention group.&#xD;
&#xD;
      Recruitment An invitation to attend an informational session will be sent to the employees in&#xD;
      the company's headquarter building in Dubai, United Arab Emirates. The invitation will&#xD;
      emphasize that participation is voluntary and that participants can withdraw at any time&#xD;
      without giving any reason. The informational session will discuss the study details (e.g.&#xD;
      eligibility criteria) and some tips for physical activity. All employees who wish to&#xD;
      participate will need to sign a consent form. The participants who are eligible will have to&#xD;
      take an appointment in the workplace health center to make the required health measurements.&#xD;
      A total of 150 participants will be recruited for the study. The eligibility of joining the&#xD;
      workplace intervention will be based on the eligibility criteria listed below.&#xD;
&#xD;
      Setting and location The intervention will be conducted in the headquarter building of a&#xD;
      semi-government telecommunication company in Dubai, United Arab Emirates. The headquarter&#xD;
      building includes a gym and swimming pool. The intervention will use the gym workplace for&#xD;
      conducting the exercise sessions.&#xD;
&#xD;
      Sample Size Previous studies concerning physical activity and cardiometabolic risk factors&#xD;
      used 80% to 91% power and effect sizes ranging between 0.51 and 1.82 to find a significant&#xD;
      difference between groups (8,10, 12-13). There are various reasons for choosing these&#xD;
      articles for sample size calculations. For example, one article used a 12-week physical&#xD;
      activity intervention and offered 3 sessions of physical activity per week (13). The same&#xD;
      article included healthy adult participants (13). In addition, the cited articles were&#xD;
      concerned with the effect of exercise on specific metabolic risk factors. These metabolic&#xD;
      risk factors were waist circumference, systolic blood pressure. fasting glucose, lipid&#xD;
      profiles (8,10, 12-13). More specifically, one article focused on waist circumference and&#xD;
      physical activity (8). In contrast another article focused on systolic blood pressure and&#xD;
      physical activity (10). For the present study, 124 participants will be required at 80%&#xD;
      power. A further 20% more participants will be added because it is expected that participants&#xD;
      might drop out during the intervention. Therefore, the investigators will recruit a total of&#xD;
      150 participants. The intervention group will have 75 participants and the delayed&#xD;
      intervention group will have 75 participants.&#xD;
&#xD;
      Statistical Analysis Analyses and reporting will be in line with CONSORT guidelines, with all&#xD;
      analyses being on an intention-to-treat principle regardless of intervention compliance. For&#xD;
      a comparison between intervention and delayed intervention arms of the 12- weeks change in&#xD;
      outcomes, the investigators plan to use analysis of covariance model, with baseline values as&#xD;
      the covariate to control for chance imbalances at baseline. Age and sex specific interaction&#xD;
      analyses will be conducted. In addition, the investigators will adopt a linear mixed model&#xD;
      approach to provide the mean intervention effect, and quantification of individual&#xD;
      differences in response to the intervention. The clinical significance of the intervention&#xD;
      effect will be elaborated with magnitude-based inferences, confidence intervals, and&#xD;
      confidence levels. Accepted regression modelling methods will be used to explore the&#xD;
      intervention effects on the secondary objectives. Multiple imputation techniques will assess&#xD;
      the sensitivity of the analyses to the missing at random assumption. Significance tests at&#xD;
      5%, either t-test or chi squared tests will be used to compare those with complete data and&#xD;
      those who have missing outcomes. Finally, the investigators will develop a detailed coding&#xD;
      scheme and coding checking protocol, cross tabulation, negative case analysis and respondent&#xD;
      validation to enhance dependability and trustworthiness.&#xD;
&#xD;
      Evaluation&#xD;
&#xD;
      The completion of the tasks in the study will evaluate its success. For example:&#xD;
&#xD;
      Inviting all employees to the informational session and selecting eligible participants.&#xD;
&#xD;
      Randomly allocating participants to the intervention and delayed intervention group&#xD;
      Collecting and analyzing blood samples pre and post the intervention period. Physical&#xD;
      activity levels recorded through IPAQ and accelerometer. Recording participants attendance to&#xD;
      personal trainer sessions. The evaluation of the intervention program will also depend on the&#xD;
      primary and secondary health outcomes of the participants in the intervention and delayed&#xD;
      intervention group. If there is a significant difference between the health outcomes of the&#xD;
      two groups then the workplace intervention would have a positive effect.&#xD;
&#xD;
      Data Management The study investigators will ensure that the participants' anonymity is&#xD;
      maintained. All data will be stored securely in an electronic database. Participants will be&#xD;
      assigned a unique research number on the electronic database. No individually identifiable&#xD;
      information will be included in the research database. The research number link to personal&#xD;
      identifying information will be maintained in a secure server physically separate from the&#xD;
      electronic database, which will be accessible only by specifically designated staff. This&#xD;
      secure linkage will allow for the subsequent addition of new information to the research&#xD;
      database, while maintaining no personal identifiers in the research database. Questionnaire&#xD;
      responses and physical measures will be maintained under the unique research number.&#xD;
&#xD;
      Informed Consent The participant must personally sign and date (on paper or electronically)&#xD;
      the latest approved version of the Informed Consent form before any study specific procedures&#xD;
      are performed. Written versions of the Participant Information Leaflet and Informed Consent&#xD;
      will be presented to the participants detailing no less than: the exact nature of the study;&#xD;
      what it will involve for the participant; the implications and constraints of the protocol;&#xD;
      the known side effects and any risks involved in taking part. It will be clearly stated that&#xD;
      the participant is free to withdraw from the study at any time for any reason without&#xD;
      prejudice to future care, and with no obligation to give the reason for withdrawal. The&#xD;
      participant will be allowed as much time as wished to consider the information, and the&#xD;
      opportunity to question the investigator or other independent parties to decide whether the&#xD;
      participant will enroll in the study. Written Informed Consent will then be obtained by means&#xD;
      of participant-dated signature and dated signature of the person who presented and obtained&#xD;
      the Informed Consent. The person who obtained the consent must be suitably qualified and&#xD;
      experienced, and have been authorized to do so by the Principal Investigator. A copy of the&#xD;
      signed Informed Consent will be given to the participant.&#xD;
&#xD;
      Patient confidentiality and data security Patient names and identifying numbers (medical&#xD;
      record number, Emirates Identification Card number etc.) will be removed from each record and&#xD;
      replaced by a unique study number. It will not be possible for the researchers to identify&#xD;
      the patients. Data will be held on the hard-drive of the researcher's computer in a locked&#xD;
      office.&#xD;
&#xD;
      Discontinuation/Withdrawal of Participants from Study Each participant has the right to&#xD;
      withdraw from the study at any time without giving any reason. Should a participant wish to&#xD;
      withdraw from the study, they are advised in the participant information leaflet to contact&#xD;
      the study coordinator. Should the participant wish for xx samples and data collected to be&#xD;
      destroyed this will be done in a prompt and secure manner and a message will be sent to the&#xD;
      person to confirm this. The reason for withdrawal, if given, will be recorded in the&#xD;
      database.&#xD;
&#xD;
      Expenses and Benefits There is no plan to offer any monetary compensation to participants but&#xD;
      if recruitment rates are lower than required, the investigators will pilot whether offering&#xD;
      free (non-monetary) gifts, certificates, first aid kits, etc. improves response rates or not.&#xD;
      For example, there will be one week where there are no gifts and another week where gifts are&#xD;
      provided and see how that affects response rates.&#xD;
&#xD;
      Risks and Benefits Assessment The main risks of participation are direct physical harm and&#xD;
      breaches of privacy/confidentiality. The risks of direct physical harm are minimal. All&#xD;
      clinical staff will receive full training on all of the study procedures, and all&#xD;
      measurements will be performed by trained staff/nurses. The exercise session will be&#xD;
      conducted under supervision of certified personal trainers to ensure proper exercise&#xD;
      techniques and therefore reduce risk of any potential injury. Participant's health&#xD;
      information will be protected by restricted access and through use of de-identified labelling&#xD;
      and use of de-identified data sets for analysis.&#xD;
&#xD;
      There are direct benefits to the individuals involved, together with the satisfaction of&#xD;
      contributing to societal benefit by the increased understanding of role of exercise at&#xD;
      workplace to improve health. The benefits of this study for science and society include but&#xD;
      not limited to increase the investigators knowledge of the role of physical activity on&#xD;
      overall health status, and risk factors for cardiovascular disease. The study aims to provide&#xD;
      direction for prevention programs, particularly in the office workers/employees who are the&#xD;
      key target group for interventions aiming to identify long lasting ways to increase&#xD;
      participation in physical activity with potential health benefits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 28, 2021</start_date>
  <completion_date type="Actual">November 30, 2021</completion_date>
  <primary_completion_date type="Actual">November 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_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.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Single blinding was used. The intervention group was renamed Group A and the delayed-intervention group as Group B to blind participants from the intervention. Participants were strongly encouraged not to disclose their allocation status during the health measurement assessments.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline high Blood Pressure (mmHg) at 12 Weeks</measure>
    <time_frame>The outcome will be measured for both groups at baseline and after the 12-week intervention.</time_frame>
    <description>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.&#xD;
Measurement Criteria:&#xD;
Systolic blood pressure ≥ 130 mm Hg OR Diastolic blood pressure ≥ 85 mm Hg</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline Waist Circumference (centimetres) at 12 Weeks</measure>
    <time_frame>The outcome will be measured for both groups at baseline and after the 12-week intervention.</time_frame>
    <description>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:&#xD;
Measurement Criteria:&#xD;
1-Waist circumference above normal (cm): &gt; 102 cm for males and &gt; 88 cm for females (9)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline HDL-cholesterol (mmol/L) at 12 Weeks</measure>
    <time_frame>The outcome will be measured for both groups at baseline and after the 12-week intervention.</time_frame>
    <description>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.&#xD;
Measurement Criteria:&#xD;
&lt; 40 mg/dL in males and &lt; 50 mg/dL in females.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline Triglycerides (mg/dL) at 12 Weeks</measure>
    <time_frame>The outcome will be measured for both groups at baseline and after the 12-week intervention.</time_frame>
    <description>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)&#xD;
Measurement Criteria:&#xD;
• Elevated Triglycerides ≥ 150 (mg/dL)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline Fasting Plasma Glucose (mmol/L) at 12 Weeks</measure>
    <time_frame>The outcome will be measured for both groups at baseline and after the 12-week intervention.</time_frame>
    <description>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).&#xD;
Measurement Criteria:&#xD;
1-Pre-diabetes: Fasting plasma glucose (mg/dL) ≥ 100 mg/dL</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Physical Activity (IPAQ Questionnaire) at 12 Weeks and 16 weeks</measure>
    <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).</time_frame>
    <description>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:&#xD;
Low physical activity&#xD;
Moderate physical activity&#xD;
High physical activity (7)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Physical Activity (AX3 Device) at 12 Weeks and 16 weeks</measure>
    <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).</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">130</enrollment>
  <condition>Cardiovascular Risk Factor</condition>
  <condition>Pre Diabetes</condition>
  <condition>High Blood Pressure</condition>
  <condition>Elevated LDL Cholesterol</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed Intervention Group (Control group)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise Time</intervention_name>
    <description>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.</description>
    <arm_group_label>Delayed Intervention Group (Control group)</arm_group_label>
    <arm_group_label>Intervention Group</arm_group_label>
    <other_name>Working hours</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Supervised Group Exercise</intervention_name>
    <description>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.</description>
    <arm_group_label>Intervention Group</arm_group_label>
    <other_name>Group exercise sessions</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Participant must be an employee in the company and have at least a waist circumference&#xD;
             of ≥94 cm (≥90 cm for South and East Asians) for males and ≥ 80 cm for females.&#xD;
&#xD;
          2. Aged 18 to 59 years old.&#xD;
&#xD;
          3. Availability of the participants for the study duration.&#xD;
&#xD;
          4. Participant is willing to commit to the intervention until the end.&#xD;
&#xD;
          5. Signed written consent to participate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severe injury in the joints or the back or any medical condition that would prevent&#xD;
             them from exercising, or the participant is advised not to exercise by a doctor.&#xD;
&#xD;
          2. Pregnant.&#xD;
&#xD;
          3. Any planned major surgical procedures during the intervention period.&#xD;
&#xD;
          4. Self-reported cardiovascular disease, lung disease, or cancer.&#xD;
&#xD;
          5. Currently participating in a health promotion program&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>59 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Javaid Nauman, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>United Arab Emirates University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emirates Integrated Telecommunication Company (Du), Headquarters Building.</name>
      <address>
        <city>Dubai</city>
        <state>Dubai Internet City</state>
        <country>United Arab Emirates</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Arab Emirates</country>
  </location_countries>
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  </reference>
  <reference>
    <citation>WHO. 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/</citation>
  </reference>
  <reference>
    <citation>WHO. United Arab Emirates health profile 2015 [Internet]. 2016. Available from: http://applications.emro.who.int/dsaf/EMROPUB_2016_EN_19276.pdf</citation>
  </reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>May 6, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>May 17, 2022</last_update_submitted>
  <last_update_submitted_qc>May 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>United Arab Emirates University</investigator_affiliation>
    <investigator_full_name>Dr. Javaid Nauman</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>cardiometabolic risk factors and exercise</keyword>
  <keyword>workplace intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Prediabetic State</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>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.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Data availability begins one year after publication. Data availability ends three years after publications</ipd_time_frame>
    <ipd_access_criteria>To researchers who provide a methodologically sound proposal and has approval from Dubai Scientific Research Ethics Committee in Dubai Health Authority.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04403789
org study id: 23081010
nct id: NCT04403789
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention 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.
primary purpose: Prevention
masking: Single (Participant)
masking description: Single blinding was used. The intervention group was renamed Group A and the delayed-intervention group as Group B to blind participants from the intervention. Participants were strongly encouraged not to disclose their allocation status during the health measurement assessments.
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.
description: 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
measure: 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.
description: 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)
measure: 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.
description: 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.
measure: 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.
description: 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)
measure: 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.
description: 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
measure: 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).
description: 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)
measure: 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).
description: 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.
arm group label: Intervention Group
arm group type: Experimental
description: 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
arm group label: Delayed Intervention Group (Control group)
arm group type: Active Comparator
description: 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
intervention type: Other
intervention name: Exercise Time
description: 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.
arm group label: Delayed Intervention Group (Control group)
arm group label: Intervention Group
other name: Working hours
intervention type: Behavioral
intervention name: Supervised Group Exercise
description: 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.
arm group label: Intervention Group
other name: Group exercise sessions
criteria: 
gender: All
minimum age: 18 Years
maximum age: 59 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Javaid Nauman, PhD
role: Principal Investigator
affiliation: United Arab Emirates University
facility: 
country: United Arab Emirates
citation: Axivity Ltd. AX3 [Internet]. AX3. 2019 [cited 2019 Jun 16]. Available from: http://www.axivity.com/product/1
citation: 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.
PMID: 30322782
citation: Cannon CP. Cardiovascular disease and modifiable cardiometabolic risk factors. Clin Cornerstone. 2007;8(3):11-28. doi: 10.1016/s1098-3597(07)80025-1.
PMID: 18452839
citation: Grundy 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. Erratum In: Circulation. 2019 Jun 18;139(25):e1182-e1186. Circulation. 2023 Aug 15;148(7):e5.
PMID: 30586774
citation: Grundy 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. Erratum In: Circulation. 2019 Jun 18;139(25):e1178-e1181.
PMID: 30565953
citation: Guthold 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. Erratum In: Lancet Glob Health. 2019 Jan;7(1):e36.
PMID: 30193830
citation: International 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
citation: 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.
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citation: Molmen-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.
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citation: Nichols 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.
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PMID: 29031002
citation: WHO. 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/
citation: WHO. United Arab Emirates health profile 2015 [Internet]. 2016. Available from: http://applications.emro.who.int/dsaf/EMROPUB_2016_EN_19276.pdf
responsible party type: Principal Investigator
investigator affiliation: United Arab Emirates University
investigator full name: Dr. Javaid Nauman
investigator title: Assistant Professor
mesh term: Hypertension
mesh term: Prediabetic State
sharing ipd: Yes
ipd description: 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.
ipd info type: Study Protocol
ipd time frame: Data availability begins one year after publication. Data availability ends three years after publications
ipd access criteria: To researchers who provide a methodologically sound proposal and has approval from Dubai Scientific Research Ethics Committee in Dubai Health Authority.