Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01628419 |
| Other study ID # |
WIN12345 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
June 21, 2012 |
| Last updated |
December 8, 2015 |
| Start date |
July 2012 |
| Est. completion date |
December 2014 |
Study information
| Verified date |
December 2015 |
| Source |
Wingate Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Israel: Ministry of Health |
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of the current investigation is to examine the effects of health intervention
program at the workplace on health risks for cardiovascular disease, well-being and
absenteeism at the workplace.
Participants: 1500 male and female employees from 10 different companies across Israel will
take part in the study. Age: older than 18 yrs.
Hypothesis 1: The intervention program will have positive effects on the health risks for
cardiovascular disease. For example: Will be reflected in a decrease in LDL and increase in
HDL.
Hypothesis 2: The intervention program will have positive effects on the absenteeism at the
workplace (e.g. decrease in days of sick leave per employee).
Description:
Introduction: The incidence of cardiovascular disease and related illnesses has been on the
rise throughout the past decades. This increase is highly linked to a diet that is both high
in calories and saturated fats as well as low levels of physical activity that may cause to
an increase of body weight, percent of body fat and in some cases to obesity. It has been
known that low levels of physical activity or sedentary behavior is a dominant risk factor
for developing cardiovascular diseases.
At the work place, employees' work capacity and efficiency can highly be affected by a
sedentary lifestyle and overweight conditions. A lack of physical activity was found to be
associated with low levels of production at the workplace. Furthermore, a positive
correlation was found between employees' lifestyle and number of days on a sick leave.
Studies have shown that obesity and a lack of physical activity are significant risk factors
for absenteeism.
In the past years, several studies have examined the effect of intervention programs on
lifestyle behavior changes and the risk of developing cardiovascular diseases(CAD). The
results of those studies are quite equivocal. Some have demonstrated a positive effect of
the intervention programs on decreasing CAD risk factors and obesity rates, while others
have found no clear effect. The conflicting results could be due to methodological issues
and different studies' designs. For example, some studies did not report the amount and the
intensity of the physical activity program used in the intervention program. Furthermore,
some intervention programs did not include a nutritional manipulation. In a recent review
papers, it was found that the most efficient programs were those that combined group
workshops, guided physical activity programs and individualized counseling sessions for
employers that were at a higher risk for developing CAD. Intervention program that included
mainly guided physical activity were found to be less effective. It should be noted that the
optimal program format that should be implemented at the workplace is not completely clear.
Study purpose: To examine the effect of health promotion intervention program at the
workplace on risk factors to cardiovascular and metabolic diseases, well-being, life-style
behavior and absenteeism at the workplace.
Subjects: The study will be approved by the local ethics committee. All participants will
sign an informed consent form. Study's participants will include adult male and female
(older than 18yrs). The 1500 participants will be recruited from 10 different worksites
across Israel.
Study protocol: The length of the intervention program at each workplace will be 6 months.
Parameters will be taken on two occasions: 1. Prior to the intervention program initiation
2. After 6 months.
Each employee at each workplace will be asked to fill a questionnaire regarding their
medical history, life-style behavior, medications, physical activity habits, and nutrition
and sleeping behavior. The employees will undergo anthropometric measurements and will be
asked to perform blood test at Health maintenance organization (HMO). The same tests will
perform at the end of the intervention program (after 6 months).
Anthropometric measures: subjects will be asked to wear light clothes. Height and weight
will be measured with no shoes. Body Mass Index (BMI) will be calculated using the common
formula (kg/m2). Circumference will be measured at two sites while the subject standing
still with both feet close together. Waist circumference will be measured at the height of
the bell-button; hip circumference will be measured at the widest point of the pelvis.
Waist-hip ratio will calculate and compared to common and updated norms. Blood pressure and
resting pulse will be measure twice while the subject is in a sitting position. The average
value will be calculated.
Blood tests: Each participant in the study will be asked to perform the following tests
prior to the beginning of the intervention program. The parameters will include: blood
glucose, hemoglobin, LDL, HDL, cholesterol, triglycerides, liver function (GGT, ALT),
Hemoglobin A1C.
Absenteeism from work (due to illnesses): With the assistance of the human resources
department, at the end of the 6 months intervention program the number of days of sick leave
will be recorded for each participant in the study. If applicable, data will be compared
with last year absenteeism.
Intervention program characteristics: Structured and guided physical activity program with a
certified trainer, General Guidelines for performing physical activity outside of working
hours, Counseling and guidelines for the kitchen staff (in organization that has food
services), Supplying general guidelines for healthy diet and nutrition, Modifying the
working environment to a health promoting one (using posters, electronic communication,
daily and weekly tips etc…), Lectures on general topics - physical activity, nutrition,
ergonomics, behavior changes, sleeping behavior.
Structured physical activity program: The training program will include, a structured
aerobic and resistance training session performed once a week with a certified trainer. The
aerobic session will include running/walking for 20min in a moderate-vigorous intensity
based on rate of perceived exertion scale from 1 (very light exercise) until 10 (very hard
and strenuous exercise). During the first two weeks the intensity will remain relatively
moderate (rate of perceived exertion 3-4), during the third week of the program the
intensity will increase to 5-6 and from the fifth week on, the intensity will increase from
6 to 8.
The resistance training will include exercise for the major muscle groups for about 15-20
min. The resistance exercises will be performed with dumbbells, resistance bands and body
weight. Additionally, the participants in the program will be asked to perform an additional
aerobic workouts for 20-30min (rate of perceived exertion 5-6) during the week, at least two
more workouts.
General guidelines for physical activity: All the participants in the study will receive
pedometers for their personal use. All employees will receive the recommended amount of
physical activity they should perform throughout the week. The information will be
distributed through information sheets, posters and e-mails. The recommendations will
include the different types of exercises that can be performed in order to improve aerobic
fitness and the recommended doses such as: amounts of daily steps, amount of weekly steps.
Furthermore, recommendations on strength, flexibility and core exercises will be provided.
Nutrition: In organizations that have food services and catering, certified dietitians from
the Wingate Institute will advise the kitchen staff about healthy nutritional choices.
Consultation will be given on the types of food to be served during meetings and events.
The professional staff will make sure that the organization provided equipment and means for
employees to bring food from home, such as: refrigerators, microwaves or oven to warm up
food, dining hall and cold water fountains.
A personal meeting will be available to the study's participants. In those meetings they
will be able to discuss personal issues and received a personal diet plan.
General nutrition guidelines: General nutritional guidelines at the workplace and during
free time will be provided to all employees. The information will be distributed through
booklets, poster, information sheet and e-mails. The guidelines will include recommendation
regarding healthy food choices, nutritional values of variety of food products, recommended
recipes etc…
Promoting health at the workplace (modifying the working environment): A representative from
the study group and the organization's management will map the working environment and will
recommend possible modifications that can be performed to the working environment in order
to make it a health promoting one. For example: improving the accessibility to spaces within
the working environment where employees can exercise, informative signage and posters
regarding healthy life-style choices, informative e-mails with weekly and monthly tips will
send to the employees.
Lectures: As part of the intervention program the employees will receive 6 lectures dealing
with different aspects of practicing a healthy life-style. The lectures will given by the
professional staff from the Wingate Institute on difference topics, such as: healthy
nutritional choices, ergonomics at the workplace, importance of performing physical
activity, sleeping habits and working capacity, behavioral tools to make a life-style
changes.
Statistical analyses: Paired t-test will be used to examine the intervention program effect
on anthropometric measures, blood tests parameters and absenteeism. The effect of the
intervention program will also be examined using multiple regressions analyses. Significant
level will set at P<0.05. SPSS software will be used for all statistical analysis.
