NCT01484834

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 2, 2011

Completed
5.7 years until next milestone

Results Posted

Study results publicly available

August 15, 2017

Completed
Last Updated

August 15, 2017

Status Verified

May 1, 2017

Enrollment Period

3 months

First QC Date

November 28, 2011

Results QC Date

December 4, 2015

Last Update Submit

May 2, 2017

Conditions

Keywords

Physical ActivityOccupational HealthQuality of LifeHealth Promotion

Outcome Measures

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).

    The participants were followed for 3 months

Secondary Outcomes (4)

  • Physical Activity Level

    The participants were followed for 3 months

  • Occupational Environment

    The participants were followed for 3 months

  • Changes in Disease Prevalence

    The participants were followed for 3 months

  • Pain Perception

    The participants were followed for 3 months

Study Arms (4)

Exercise and Education

EXPERIMENTAL

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

ACTIVE COMPARATOR

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

Educational Intervention

ACTIVE COMPARATOR

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

Control Company

PLACEBO COMPARATOR

No intervention

Other: Control Company

Interventions

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
Exercise and Education
ExerciseBEHAVIORAL

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
Exercise

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
Educational Intervention

No intervention was applied for the participants of this group

Control Company

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Metodista de Piracicaba

Piracicaba, São Paulo, 13400-911, Brazil

Location

MeSH Terms

Conditions

Health BehaviorMotor Activity

Interventions

ExerciseEducational StatusEarly Intervention, Educational

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaSocioeconomic FactorsPopulation CharacteristicsChild Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Results Point of Contact

Title
Dr. Antonio Jose Grande
Organization
UNESC

Study Officials

  • Antonio J Grande, PhD

    Universidade Metodista de Piracicaba

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 28, 2011

First Posted

December 2, 2011

Study Start

August 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

August 15, 2017

Results First Posted

August 15, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will share

Data are available when required

Locations