Trial Outcomes & Findings for Comparison of Interventions to Promote Health in Workers (NCT NCT01484834)
NCT ID: NCT01484834
Last Updated: 2017-08-15
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
190 participants
Primary outcome timeframe
The participants were followed for 3 months
Results posted on
2017-08-15
Participant Flow
Administrative workplace
Participant milestones
| Measure |
Exercise in the Workplace and Educational Intervention
Company A received exercise in the workplace, posters with tips on health and quality of life computer software
Exercise, Educational Intervention: 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
|
Exercise in the Workplace
Exercise in the workplace was prescribed three times per week with fifteen minutes of duration. The exercises were mild.
Exercise, Educational Intervention: 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
|
Educational Intervention
This company received a quality of life software and poster with tips on health lifestyle.
Exercise, Educational Intervention: 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
|
Control Company
No intervention. Control group received no intervention during study period
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
65
|
62
|
39
|
24
|
|
Overall Study
COMPLETED
|
60
|
54
|
38
|
20
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
1
|
4
|
Reasons for withdrawal
| Measure |
Exercise in the Workplace and Educational Intervention
Company A received exercise in the workplace, posters with tips on health and quality of life computer software
Exercise, Educational Intervention: 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
|
Exercise in the Workplace
Exercise in the workplace was prescribed three times per week with fifteen minutes of duration. The exercises were mild.
Exercise, Educational Intervention: 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
|
Educational Intervention
This company received a quality of life software and poster with tips on health lifestyle.
Exercise, Educational Intervention: 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
|
Control Company
No intervention. Control group received no intervention during study period
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
8
|
1
|
4
|
Baseline Characteristics
Comparison of Interventions to Promote Health in Workers
Baseline characteristics by cohort
| Measure |
Exercise in the Workplace and Educational Intervention
n=65 Participants
Participants received exercise in the workplace and educational intervention
|
Exercise in the Workplace
n=62 Participants
Participants received exercise only
|
Educational Intervention
n=39 Participants
Participants received educational intervention only
|
Control Company
n=24 Participants
Participants did not receive any intervention
|
Total
n=190 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
65 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
190 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
24.6 years
STANDARD_DEVIATION 3.54 • n=5 Participants
|
23.9 years
STANDARD_DEVIATION 5.23 • n=7 Participants
|
28.6 years
STANDARD_DEVIATION 7.57 • n=5 Participants
|
27.2 years
STANDARD_DEVIATION 7.7 • n=4 Participants
|
26 years
STANDARD_DEVIATION 6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
97 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
93 Participants
n=21 Participants
|
|
Region of Enrollment
Brazil
|
65 participants
n=5 Participants
|
62 participants
n=7 Participants
|
39 participants
n=5 Participants
|
24 participants
n=4 Participants
|
190 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: The participants were followed for 3 monthsThe 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).
Outcome measures
| Measure |
Exercise in the Workplace and Educational Intervention
n=60 Participants
Company A received exercise in the workplace, posters with tips on health and quality of life computer software
Exercise, Educational Intervention: 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
|
Exercise in the Workplace
n=54 Participants
Exercise in the workplace was prescribed three times per week with fifteen minutes of duration. The exercises were mild.
Exercise, Educational Intervention: 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
|
Educational Intervention
n=38 Participants
This company received a quality of life software and poster with tips on health lifestyle.
Exercise, Educational Intervention: 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
|
Control Company
n=20 Participants
No intervention. Control group received no intervention during study period
|
|---|---|---|---|---|
|
Quality of Life
|
71.5 units on a scale
Standard Deviation 3.1
|
68.5 units on a scale
Standard Deviation 3.0
|
72 units on a scale
Standard Deviation 4.0
|
72 units on a scale
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: The participants were followed for 3 monthsThe 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).
Outcome measures
| Measure |
Exercise in the Workplace and Educational Intervention
n=60 Participants
Company A received exercise in the workplace, posters with tips on health and quality of life computer software
Exercise, Educational Intervention: 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
|
Exercise in the Workplace
n=54 Participants
Exercise in the workplace was prescribed three times per week with fifteen minutes of duration. The exercises were mild.
Exercise, Educational Intervention: 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
|
Educational Intervention
n=38 Participants
This company received a quality of life software and poster with tips on health lifestyle.
Exercise, Educational Intervention: 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
|
Control Company
n=20 Participants
No intervention. Control group received no intervention during study period
|
|---|---|---|---|---|
|
Physical Activity Level
|
30 units on a scale
Standard Deviation 3.5
|
27 units on a scale
Standard Deviation 3.1
|
36 units on a scale
Standard Deviation 7.2
|
36 units on a scale
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: The participants were followed for 3 monthsThe 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).
Outcome measures
| Measure |
Exercise in the Workplace and Educational Intervention
n=60 Participants
Company A received exercise in the workplace, posters with tips on health and quality of life computer software
Exercise, Educational Intervention: 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
|
Exercise in the Workplace
n=54 Participants
Exercise in the workplace was prescribed three times per week with fifteen minutes of duration. The exercises were mild.
Exercise, Educational Intervention: 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
|
Educational Intervention
n=38 Participants
This company received a quality of life software and poster with tips on health lifestyle.
Exercise, Educational Intervention: 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
|
Control Company
n=20 Participants
No intervention. Control group received no intervention during study period
|
|---|---|---|---|---|
|
Occupational Environment
|
70 units on a scale 0-100
Standard Deviation 5.3
|
65 units on a scale 0-100
Standard Deviation 4.2
|
45 units on a scale 0-100
Standard Deviation 6.5
|
52 units on a scale 0-100
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: The participants were followed for 3 monthsthe changes in disease prevalence was measured in the same instrument QVS-80. The chronic disease was self-related by the participants.
Outcome measures
| Measure |
Exercise in the Workplace and Educational Intervention
n=60 Participants
Company A received exercise in the workplace, posters with tips on health and quality of life computer software
Exercise, Educational Intervention: 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
|
Exercise in the Workplace
n=54 Participants
Exercise in the workplace was prescribed three times per week with fifteen minutes of duration. The exercises were mild.
Exercise, Educational Intervention: 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
|
Educational Intervention
n=38 Participants
This company received a quality of life software and poster with tips on health lifestyle.
Exercise, Educational Intervention: 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
|
Control Company
n=20 Participants
No intervention. Control group received no intervention during study period
|
|---|---|---|---|---|
|
Changes in Disease Prevalence
Hypertension
|
2 participants
Interval 0.0 to 2.0
|
2 participants
Interval 0.0 to 2.0
|
1 participants
Interval 0.0 to 1.0
|
5 participants
Interval 0.0 to 5.0
|
|
Changes in Disease Prevalence
Overweight
|
11 participants
Interval 0.0 to 11.0
|
14 participants
Interval 0.0 to 14.0
|
16 participants
Interval 0.0 to 16.0
|
8 participants
Interval 0.0 to 8.0
|
|
Changes in Disease Prevalence
Dislipedemy
|
3 participants
Interval 0.0 to 3.0
|
6 participants
Interval 0.0 to 6.0
|
1 participants
Interval 0.0 to 1.0
|
0 participants
Interval 0.0 to 0.0
|
|
Changes in Disease Prevalence
Asthma
|
2 participants
Interval 0.0 to 2.0
|
11 participants
Interval 0.0 to 11.0
|
6 participants
Interval 0.0 to 6.0
|
3 participants
Interval 0.0 to 3.0
|
|
Changes in Disease Prevalence
Thyreopathy
|
2 participants
Interval 0.0 to 2.0
|
3 participants
Interval 0.0 to 3.0
|
2 participants
Interval 0.0 to 2.0
|
0 participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: The participants were followed for 3 monthsPain 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.
Outcome measures
| Measure |
Exercise in the Workplace and Educational Intervention
n=60 Participants
Company A received exercise in the workplace, posters with tips on health and quality of life computer software
Exercise, Educational Intervention: 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
|
Exercise in the Workplace
n=54 Participants
Exercise in the workplace was prescribed three times per week with fifteen minutes of duration. The exercises were mild.
Exercise, Educational Intervention: 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
|
Educational Intervention
n=38 Participants
This company received a quality of life software and poster with tips on health lifestyle.
Exercise, Educational Intervention: 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
|
Control Company
n=20 Participants
No intervention. Control group received no intervention during study period
|
|---|---|---|---|---|
|
Pain Perception
|
2.29 Odds Ratio
Interval 0.87 to 5.99
|
3.74 Odds Ratio
Interval 1.16 to 12.02
|
0.94 Odds Ratio
Interval 0.38 to 2.34
|
1.07 Odds Ratio
Interval 0.34 to 3.27
|
Adverse Events
Exercise in the Workplace and Educational Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Exercise in the Workplace
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Educational Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Company
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place