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CompletedNCT01484834Updated Aug 15, 2017Results posted

Comparison of Interventions to Promote Health in Workers

An interventional study of Exercise and Education and Exercise in Health Behavior, sponsored by Universidade Metodista de Piracicaba. Completed at 1 site in Brazil. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-15.

Sponsored by Universidade Metodista de Piracicaba · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
190
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

The goal of this research was to investigate different intervention strategies in the workplace and their impact on quality of life of workers from companies in the city of Londrina, Parana, Brazil.

The interventions were composed by exercise in the workplace and educational interventions.

Read the detailed description

The workplace has special features about human behaviors. Studies (Shepard 1996, Pratt 2008) has shown that workers participate of this kind of health promotion programs for various reasons: One reason is the convenience of doing something without having to look for it; another reason is group support, many workers who share difficulties due to their working demands can find support in each other, so that they could change health behavior. Furthermore there are patterns of formal and informal communication that can contribute to help more people to become healthier making their environment better. Finally, the norms of a corporate behavior can unite the group of workers seeking same objectives.

Additionally the literature has shown that adults increased workload, job insecurity and pressure to perform tasks (Sparks 1997). These facts has been shown that workplace is different from community based interventions and leisure interventions.

The outcomes proposed to study are different from other studies since the interventions focus changes in behaviors. Sedentary behavior has shown to have 23% of deaths from major chronic disease (WHO 2002).

As the populations rises around the world and with the prolonged life expectancies, the number of people with chronic diseases will raise (WHO 2006). By having positive changes in health behavior the costs of public health can be reduced. Studying different types of interventions and testing its efficacy in different places can help the policy makers to create healthier environments.

There are strategies being developed in the workplace, but its efficacy is being challenged. There are some researches that show no evidence to prove the continuity of these interventions and there are evidences proving the opposite, positive changes in clinical outcomes as diabetes, blood pressure and elevated blood cholesterol. In addition some measures as BMI, anthropometric, fitness level have shown good association as prediction of development of chronic disease with low cost (Dishman 2004).

02

Conditions studied

  • Health Behavior

Keywords

  • Physical Activity
  • Occupational Health
  • Quality of Life
  • Health Promotion
03

In context

Lead sponsor

Universidade Metodista de Piracicaba is the lead sponsor of 34 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria The inclusion criteria for participation of these study were never participated of and quality of life and health intervention program at work and had an interest in participating in the study. Included workers ≥ 18years who had to work in the office position, sitting at the computer most of the work shift.

Exclusion criteria: temporary workers and freelancers.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
190 participants (actual)

Study arms

  • Experimental
    Exercise and Education

    Company A received intervention of exercise in the workplace, posters with tips on health and quality of life computer software. The interventions with physical exercise in the workplace, were performed in the morning shift and had duration of three months with 15 minutes each and were applied three times per week every other day. In order to keep the workers motivated and participating in the exercise in the workplace, the sessions were very varied, using broomstick, latex tubes, exercises in pairs, massage, sitting exercises and relaxation on mats.

    Behavioral: Exercise and Education

  • Active comparator
    Exercise

    The intervention with physical exercise in the workplace, were performed in the morning shift and had duration of three months with 15 minutes each and were applied three times per week every other day. In order to keep the workers motivated and participating in the exercise in the workplace, the sessions were very varied, using broomstick, latex tubes, exercises in pairs, massage, sitting exercises and relaxation on mats.

    Behavioral: Exercise

  • Active comparator
    Educational Intervention

    This company received a quality of life software and poster intervention with tips on health lifestyle. The posters were printed in A3 paper and eight of them were put up per month in different parts of the companies (near water fountains, rest places, cafeterias, near the restrooms and change rooms). The used messages, both by the posters and the software were basedon scientific evidence related to quality of life and health

    Behavioral: Educational Intervention

  • Placebo comparator
    Control Company

    No intervention

    Other: Control Company

Interventions

  • BehavioralExercise and Education

    Exercise were prescribed three times a week with duration of fifteen minutes for three months. Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors

    Also known as: Worksite interventions, Physical activity at the workplace

  • BehavioralExercise

    Exercise were prescribed three times a week with duration of fifteen minutes for three months.

    Also known as: Worksite interventions, Physical activity at the workplace

  • BehavioralEducational Intervention

    This company received a quality of life software and poster intervention with tips on health lifestyle. The posters were printed in A3 paper and eight of them were put up per month in different parts of the companies (near water fountains, rest places, cafeterias, near the restrooms and change rooms). The used messages, both by the posters and the software were basedon scientific evidence related to quality of life and health

    Also known as: Worksite interventions, Physical activity at the workplace

  • OtherControl Company

    No intervention was applied for the participants of this group

06

What researchers measure

Primary outcomes

  1. Quality of Life

    The instrument contains 80 questions, of which 67 were structured in 5 points Lickert Scale. QVS-80 has four domains: Health Domain (Health) Physical activity (PA), occupational environment domain (AO) and perception of QoL (QOL). The health domain is composed of 30 questions, and the thirteen initial questions refer to history of the existence of chronic diseases such as hypertension, diabetes, obesity, dyslipidemias, bronchitis, allergic rhinitis and cancer; the remaining questions relate to lifestyle and living habits, such as quality of sleep, smoking and consumption of alcohol. The domain of physical activity consists of 15 questions on physical activity. The Domain workplace consists of 11 questions about the physical activity at work and occupational environment. The Domain perception of QoL consists of 24 questions about personal characteristics, and autonomy. The syntax of QVS-80 put the results in a scale of 0 -100 points (the higher the better).

    Time frame: The participants were followed for 3 months

Secondary outcomes

  1. Physical Activity Level

    The level of physical activity was evaluated by the questionnaire of quality of life. (QVS-80). The physical activity domain is composed of 15 questions considering the ammount of physical activity practiced during leisure time. The instrument is structured in 5 points Lickert Scale. The syntax of QVS-80 put the results in a scale of 0 -100 points (the higher the better).

    Time frame: The participants were followed for 3 months

  2. Occupational Environment

    The occupational environment was assessed by the quality of life questionnaire. (QVS-80). It considers physical aspects like accessibility and psycologic aspects such as stress. The domain consists of 11 questions about occupational environment. The syntax of QVS-80 put the results in a scale of 0 -100 points (the higher the better).

    Time frame: The participants were followed for 3 months

  3. Changes in Disease Prevalence

    the changes in disease prevalence was measured in the same instrument QVS-80. The chronic disease was self-related by the participants.

    Time frame: The participants were followed for 3 months

  4. Pain Perception

    Pain perception were evaluated by the diagram of pain proposed by Corlett in 1995. The part of body which had pain were indicated by the participant. The data were analysed as "yes" or "no" and reported as Odds ratio.

    Time frame: The participants were followed for 3 months

07

Results

Posted Aug 15, 2017

Participant flow

Administrative workplace

Participant flow — Overall Study
MilestoneExercise in the Workplace and Educational InterventionExercise in the WorkplaceEducational InterventionControl Company
Started65623924
Completed60543820
Not completed5814
Withdrew: Lost to follow-up5814

Outcome measures

PrimaryQuality of Life

The instrument contains 80 questions, of which 67 were structured in 5 points Lickert Scale. QVS-80 has four domains: Health Domain (Health) Physical activity (PA), occupational environment domain (AO) and perception of QoL (QOL). The health domain is composed of 30 questions, and the thirteen initial questions refer to history of the existence of chronic diseases such as hypertension, diabetes, obesity, dyslipidemias, bronchitis, allergic rhinitis and cancer; the remaining questions relate to lifestyle and living habits, such as quality of sleep, smoking and consumption of alcohol. The domain of physical activity consists of 15 questions on physical activity. The Domain workplace consists of 11 questions about the physical activity at work and occupational environment. The Domain perception of QoL consists of 24 questions about personal characteristics, and autonomy. The syntax of QVS-80 put the results in a scale of 0 -100 points (the higher the better).

Time frame:
The participants were followed for 3 months
Reported as:
Median · units on a scale
Quality of Life
units on a scaleExercise in the Workplace and Educational InterventionExercise in the WorkplaceEducational InterventionControl Company
Quality of Life71.5 ± 3.168.5 ± 3.072 ± 4.072 ± 3.3
SecondaryPhysical Activity Level

The level of physical activity was evaluated by the questionnaire of quality of life. (QVS-80). The physical activity domain is composed of 15 questions considering the ammount of physical activity practiced during leisure time. The instrument is structured in 5 points Lickert Scale. The syntax of QVS-80 put the results in a scale of 0 -100 points (the higher the better).

Time frame:
The participants were followed for 3 months
Reported as:
Median · units on a scale
Physical Activity Level
units on a scaleExercise in the Workplace and Educational InterventionExercise in the WorkplaceEducational InterventionControl Company
Physical Activity Level30 ± 3.527 ± 3.136 ± 7.236 ± 8.2
SecondaryOccupational Environment

The occupational environment was assessed by the quality of life questionnaire. (QVS-80). It considers physical aspects like accessibility and psycologic aspects such as stress. The domain consists of 11 questions about occupational environment. The syntax of QVS-80 put the results in a scale of 0 -100 points (the higher the better).

Time frame:
The participants were followed for 3 months
Reported as:
Median · units on a scale 0-100
Occupational Environment
units on a scale 0-100Exercise in the Workplace and Educational InterventionExercise in the WorkplaceEducational InterventionControl Company
Occupational Environment70 ± 5.365 ± 4.245 ± 6.552 ± 4.2
SecondaryChanges in Disease Prevalence

the changes in disease prevalence was measured in the same instrument QVS-80. The chronic disease was self-related by the participants.

Time frame:
The participants were followed for 3 months
Reported as:
Number · participants
Changes in Disease Prevalence
participantsExercise in the Workplace and Educational InterventionExercise in the WorkplaceEducational InterventionControl Company
Hypertension2 (0 to 2)2 (0 to 2)1 (0 to 1)5 (0 to 5)
Overweight11 (0 to 11)14 (0 to 14)16 (0 to 16)8 (0 to 8)
Dislipedemy3 (0 to 3)6 (0 to 6)1 (0 to 1)0 (0 to 0)
Asthma2 (0 to 2)11 (0 to 11)6 (0 to 6)3 (0 to 3)
Thyreopathy2 (0 to 2)3 (0 to 3)2 (0 to 2)0 (0 to 0)
SecondaryPain Perception

Pain perception were evaluated by the diagram of pain proposed by Corlett in 1995. The part of body which had pain were indicated by the participant. The data were analysed as "yes" or "no" and reported as Odds ratio.

Time frame:
The participants were followed for 3 months
Reported as:
Number · Odds Ratio
Pain Perception
Odds RatioExercise in the Workplace and Educational InterventionExercise in the WorkplaceEducational InterventionControl Company
Pain Perception2.29 (0.87 to 5.99)3.74 (1.16 to 12.02)0.94 (0.38 to 2.34)1.07 (0.34 to 3.27)

Adverse events

Collected over data were collected after 3 months.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Exercise in the Workplace and Educational Intervention—0/65 (0%)0/65 (0%)
Exercise in the Workplace—0/62 (0%)0/62 (0%)
Educational Intervention—0/39 (0%)0/39 (0%)
Control Company—0/24 (0%)0/24 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Exercise in the Workplace and Educational InterventionExercise in the WorkplaceEducational InterventionControl CompanyTotal
<=18 years00000
Between 18 and 65 years65623924190
>=65 years00000
Age, Continuous
Age, Continuous(years)Exercise in the Workplace and Educational InterventionExercise in the WorkplaceEducational InterventionControl CompanyTotal
Mean24.6 ± 3.5423.9 ± 5.2328.6 ± 7.5727.2 ± 7.726 ± 6
Sex: Female, Male
Sex: Female, Male(Participants)Exercise in the Workplace and Educational InterventionExercise in the WorkplaceEducational InterventionControl CompanyTotal
Female443315597
Male2129241993
Region of Enrollment
Region of Enrollment(participants)Exercise in the Workplace and Educational InterventionExercise in the WorkplaceEducational InterventionControl CompanyTotal
Brazil65623924190
08

Study locations

1 site
  • Universidade Metodista de Piracicaba
    Piracicaba, São Paulo 13400-911, Brazil
09

References and documents

Individual participant data

Plan to share: Yes — Data are available when required

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01484834
Lead sponsor
Universidade Metodista de Piracicaba
Responsible party
Antonio Jose Grande (Principal Investigator, Universidade Metodista de Piracicaba) — Principal investigator
First posted
Dec 2, 2011
Start date
Aug 2011
Primary completion
Nov 2011
Completion
Nov 2011
Results posted
Aug 15, 2017
Last update
Aug 15, 2017

Study contacts

Antonio J Grande, PhD
principal investigator · Universidade Metodista de Piracicaba

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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