We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is not yet open for participant recruitment.
Verified March 2017 by Rosimeire Simprini Padula, Universidade Cidade de Sao Paulo
Sponsor:
ClinicalTrials.gov Identifier:
NCT02980237
First Posted: December 2, 2016
Last Update Posted: March 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Rosimeire Simprini Padula, Universidade Cidade de Sao Paulo
  Purpose
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

Condition Intervention
Health Behavior Other: eHealth_additional support Other: eHealth_program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Further study details as provided by Rosimeire Simprini Padula, Universidade Cidade de Sao Paulo:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.

  • 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.

  • 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.


Estimated Enrollment: 384
Anticipated Study Start Date: April 20, 2017
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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. .

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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02980237


Contacts
Contact: Rosimeire S Padula, PhD 11951583131 rosipadula@gmail.com

Locations
Brazil
Rosimeire Simprini Padula
Atibaia, SP, Brazil, 12942-770
Sponsors and Collaborators
Rosimeire Simprini Padula
Investigators
Study Director: Rosimeire S Padula, PhD Universidade Cidade de São Paulo
  More Information

Publications:

Responsible Party: Rosimeire Simprini Padula, PhD, Universidade Cidade de Sao Paulo
ClinicalTrials.gov Identifier: NCT02980237     History of Changes
Other Study ID Numbers: 1.023.328
First Submitted: August 23, 2016
First Posted: December 2, 2016
Last Update Posted: March 7, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rosimeire Simprini Padula, Universidade Cidade de Sao Paulo:
Office workers
Quality of life
e-Learning
Occupational health