e-Health Education Program at Workplace (e-Health)

April 16, 2019 updated by: Rosimeire Simprini Padula

Effectiveness of an e-Health Program at Workplace in the Promotion of Quality of Life of Office Workers: Protocol of a Randomized Controlled Trial by Cluster

The objective this study is evaluate if an e-Health education program at the workplace to contributes to improve quality of life from Office Workers. And:Life style modification; Improve physical activity Reduces on Anthropometric Measures; Reduces Pain and discomfort in the musculoskeletal system

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objective: The purpose of this study is evaluate the effectiveness of an e-Health education program at the workplace in the quality of life promotion.

Design: Double Blinded. Randomized clinical trial by cluster. Setting: Office Workers of the Universidade Publica do Estado da Bahia, Bahia State, Brazil. Participants: 348 office workers are enrollment, both sex, with over 18 year old.

Intervention: Participants will randomized in: (1) reference group will receive an e-learning health education compose by nine video-class according to the dimensions: 1) musculoskeletal health, 2) eating health e 3) mental health. A video will available by moodle platform every 20 days during six months. In this period the workers will monitored regarding to access the videos and and reinforcements to remain in the program. (2) intervention group: they will receive e-health education program with additional support healthcare tutor everyday.

Study Type

Interventional

Enrollment (Actual)

384

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Atibaia, SP, Brazil, 12942-770
        • Rosimeire Simprini Padula

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Technical-administrative workers, computer users for a minimum period of six months. ,
  • Signed informed consent form

Exclusion Criteria:

  • Suspected or confirmed pregnant workers at randomization time
  • Mothers what Breastfeeding
  • Workers in annual leave.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: eHealth_additional support
An e-learning education program whose audiovisual content will be implemented. The course could be access in the workplace but they will be additional support.
Other: eHealth_additional support
An e-learning education program whose audiovisual content will be implemented. Nine audiovisual e-Health program will be composed of nine video classes addressing the following topics: 1) musculoskeletal health, 2) healthy diet and 3) mental health were identified through focus group. A communication tool will be adopted is the Moodle environment. All the participants will be able to whipping the web platform and questions regarding access and navigation are answered by e-mail. All participants will be monitored, as viewing the videos, and whenever it is identified that the participants not accessed and lack of interest of reasons. A team of tutors will be responsible for online support providing reinforcing stimuli and clarifying any questions (intervention group) on the content.
Active Comparator: eHealth
This group will receive an e-learning education program same as the intervention group . However, the participants will not receive additional support by team.
Other: eHealth_program
The comparative group will receive the same eHealth education program that intervention group. But the comparative group will receive only audiovisuals without additional support. .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline Quality of life at 6 and 8 months
Time Frame: Baseline, 6 and 8 months
A questionnaire to evaluate the improve the quality of life after 6 and 8 months after began the program will be used (WHOQOL-BREF :instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment).
Baseline, 6 and 8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Anthropometric measure at 6 and 8 months
Time Frame: Baseline, 6 and 8 months
Changes on anthropometric measurements (weight, abdominal circumference, waist circumference, hip circumference, body mass and height). For this study, body mass index (BMI), body fat percentage (BFP) and waist-hip ratio will be used and assessment 6 and 8 months after starting the eHealth program.
Baseline, 6 and 8 months
Change from Pain and/or musculoskeletal discomfort measure at 6 and 8 months
Time Frame: Baseline, 6 and 8 months
To assessement the intensity of musculoskeletal complains (pain and discomfort) in baseline and 6 and 8 months an after starting the eHealth program.
Baseline, 6 and 8 months
Change from Lifestyle at 6 and 8 months
Time Frame: Baseline, 6 and 8 months
Change in health behavior, in physical activity level (min/week) after starting the eHealth program in 6 and 8 months will be measured.
Baseline, 6 and 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rosimeire Simprini Padula

Investigators

  • Study Director: Rosimeire S Padula, PhD, Universidade Cidade de Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2017

Primary Completion (Actual)

October 17, 2017

Study Completion (Actual)

March 2, 2018

Study Registration Dates

First Submitted

August 23, 2016

First Submitted That Met QC Criteria

November 29, 2016

First Posted (Estimate)

December 2, 2016

Study Record Updates

Last Update Posted (Actual)

April 17, 2019

Last Update Submitted That Met QC Criteria

April 16, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1.023.328

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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