Effects of a Workplace Exercise Intervention on Cardio-Metabolic Health
Condition: Cardiovascular Risk Factor; Pre Diabetes; High Blood Pressure; Elevated LDL Cholesterol
MeSH terms: Hypertension; Prediabetic State
Study type: Interventional

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. 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.
    

Intervention name(s): Exercise Time; Supervised Group Exercise
Intervention type(s): Other; Behavioral
Intervention description(s): 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.; 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.
Other intervention name(s): Working hours; Group exercise sessions
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.
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: cardiometabolic risk factors and exercise; workplace intervention