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Comparison of Interventions to Promote Health in Workers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Antonio Jose Grande, Universidade Metodista de Piracicaba
ClinicalTrials.gov Identifier:
NCT01484834
First received: November 28, 2011
Last updated: May 2, 2017
Last verified: May 2017
  Purpose

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.


Condition Intervention
Health Behavior Behavioral: Exercise and Education Behavioral: Exercise Behavioral: Educational Intervention Other: Control Company

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Comparison of Interventions to Promote Health in Workers: A Cluster Randomized Controled Trial

Resource links provided by NLM:


Further study details as provided by Antonio Jose Grande, Universidade Metodista de Piracicaba:

Primary Outcome Measures:
  • Quality of Life [ Time Frame: The participants were followed for 3 months ]
    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).


Secondary Outcome Measures:
  • Physical Activity Level [ Time Frame: The participants were followed for 3 months ]
    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).

  • Occupational Environment [ Time Frame: The participants were followed for 3 months ]
    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).

  • Changes in Disease Prevalence [ Time Frame: The participants were followed for 3 months ]
    the changes in disease prevalence was measured in the same instrument QVS-80. The chronic disease was self-related by the participants.

  • Pain Perception [ Time Frame: The participants were followed for 3 months ]
    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.


Enrollment: 190
Study Start Date: August 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Other Names:
  • Worksite interventions
  • Physical activity at the workplace
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
Exercise were prescribed three times a week with duration of fifteen minutes for three months.
Other Names:
  • Worksite interventions
  • Physical activity at the workplace
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
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
Other Names:
  • Worksite interventions
  • Physical activity at the workplace
Placebo Comparator: Control Company
No intervention
Other: Control Company
No intervention was applied for the participants of this group

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).

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01484834

Locations
Brazil
Universidade Metodista de Piracicaba
Piracicaba, São Paulo, Brazil, 13400-911
Sponsors and Collaborators
Universidade Metodista de Piracicaba
Investigators
Principal Investigator: Antonio J Grande, PhD Universidade Metodista de Piracicaba
  More Information

Responsible Party: Antonio Jose Grande, Principal Investigator, Universidade Metodista de Piracicaba
ClinicalTrials.gov Identifier: NCT01484834     History of Changes
Other Study ID Numbers: UMetodistaPiracicaba-2011
Study First Received: November 28, 2011
Results First Received: December 4, 2015
Last Updated: May 2, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data are available when required

Keywords provided by Antonio Jose Grande, Universidade Metodista de Piracicaba:
Physical Activity
Occupational Health
Quality of Life
Health Promotion

ClinicalTrials.gov processed this record on September 19, 2017