e-Health Education Program at Workplace

Sponsor

Rosimeire Simprini Padula (Other)

Overall Status

Completed

CT.gov ID

NCT02980237

Collaborator

(none)

384

Enrollment

Location

Arms

10.4

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Health Behavior	Other: eHealth_additional support Other: eHealth_program	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

384 participants

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

Actual Study Start Date :

Apr 20, 2017

Actual Primary Completion Date :

Oct 17, 2017

Actual Study Completion Date :

Mar 2, 2018

Arms and Interventions

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. .

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. .

Outcome Measures

Primary Outcome Measures

Change from baseline Quality of life at 6 and 8 months [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rosimeire Simprini Padula, PhD, Universidade Cidade de Sao Paulo

ClinicalTrials.gov Identifier:

NCT02980237

Other Study ID Numbers:

1.023.328

First Posted:

Dec 2, 2016

Last Update Posted:

Apr 17, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Rosimeire Simprini Padula, PhD, Universidade Cidade de Sao Paulo

Study Results

No Results Posted as of Apr 17, 2019