Health Behaviore-HealthNCT02980237
e-Health Education Program at Workplace
A study testing eHealth_additional support and eHealth_program in people with Health Behavior, run by Rosimeire Simprini Padula at 1 site in Brazil.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- eHealth_additional support and eHealth_program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Apr 2017to 2 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Technical-administrative workers, computer users for a minimum period of six months. ,
- Signed informed consent form
Who cannot join
- Suspected or confirmed pregnant workers at randomization time
- Mothers what Breastfeeding
- Workers in annual leave.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Health Behavior
- Being tested
- eHealth_additional support, eHealth_program
- Keywords
- Office workers, Quality of life, e-Learning, Occupational health
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eHealth_additional supportOther
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.
eHealth_programOther
The comparative group will receive the same eHealth education program that intervention group. But the comparative group will receive only audiovisuals without additional support. .
| Study group | Role | What they receive |
|---|---|---|
| eHealth_additional support | Experimental | 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. Receives: Other: eHealth_additional support |
| eHealth | Active comparator | This group will receive an e-learning education program same as the intervention group . However, the participants will not receive additional support by team. Receives: Other: eHealth_program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Quality of life at 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).
Measured: Baseline, 6 and 8 months
Secondary outcomes (3)
Change from Anthropometric measure at 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.
Measured: Baseline, 6 and 8 months
Change from Pain and/or musculoskeletal discomfort measure at 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.
Measured: Baseline, 6 and 8 months
Change from Lifestyle at 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.
Measured: Baseline, 6 and 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study start20 Apr 2017
- Primary completion17 Oct 2017
- Study completion2 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rosimeire Simprini Padula
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rosimeire Simprini Padula, Universidade Cidade de Sao Paulo
- Investigators
- Rosimeire S Padula, PhD, Study director, Universidade Cidade de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980237
- Sponsor's protocol ID
- 1.023.328
- Acronym
- e-Health
- Status last verified
- Apr 2019
- First submitted
- 23 Aug 2016
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Andersen JH, Fallentin N, Thomsen JF, Mikkelsen S. Risk factors for neck and upper extremity disorders among computers users and the effect of interventions: an overview of systematic reviews. PLoS One. 2011 May 12;6(5):e19691. doi: 10.1371/journal.pone.0019691.
PubMed 21589875Dillon C, Petersen M, Tanaka S. Self-reported hand and wrist arthritis and occupation: data from the U.S. National Health Interview Survey-Occupational Health Supplement. Am J Ind Med. 2002 Oct;42(4):318-27. doi: 10.1002/ajim.10117.
PubMed 12271479Mulder R, Pouwelse M, Lodewijkx H, Bolman C. Workplace mobbing and bystanders' helping behaviour towards victims: the role of gender, perceived responsibility and anticipated stigma by association. Int J Psychol. 2014 Aug;49(4):304-12. doi: 10.1002/ijop.12018. Epub 2013 Nov 20.
PubMed 24990642Raman SR, Al-Halabi B, Hamdan E, Landry MD. Prevalence and risk factors associated with self-reported carpal tunnel syndrome (CTS) among office workers in Kuwait. BMC Res Notes. 2012 Jun 13;5:289. doi: 10.1186/1756-0500-5-289.
PubMed 22695029Thorp AA, Owen N, Neuhaus M, Dunstan DW. Sedentary behaviors and subsequent health outcomes in adults a systematic review of longitudinal studies, 1996-2011. Am J Prev Med. 2011 Aug;41(2):207-15. doi: 10.1016/j.amepre.2011.05.004.
PubMed 21767729Waersted M, Hanvold TN, Veiersted KB. Computer work and musculoskeletal disorders of the neck and upper extremity: a systematic review. BMC Musculoskelet Disord. 2010 Apr 29;11:79. doi: 10.1186/1471-2474-11-79.
PubMed 20429925Bernal D, Campos-Serna J, Tobias A, Vargas-Prada S, Benavides FG, Serra C. Work-related psychosocial risk factors and musculoskeletal disorders in hospital nurses and nursing aides: a systematic review and meta-analysis. Int J Nurs Stud. 2015 Feb;52(2):635-48. doi: 10.1016/j.ijnurstu.2014.11.003. Epub 2014 Nov 15.
PubMed 25480459Bandoni DH, Sarno F, Jaime PC. Impact of an intervention on the availability and consumption of fruits and vegetables in the workplace. Public Health Nutr. 2011 Jun;14(6):975-81. doi: 10.1017/S1368980010003460. Epub 2010 Dec 21.
PubMed 21205408Cash SW, Beresford SA, Henderson JA, McTiernan A, Xiao L, Wang CY, Patrick DL. Dietary and physical activity behaviours related to obesity-specific quality of life and work productivity: baseline results from a worksite trial. Br J Nutr. 2012 Sep 28;108(6):1134-42. doi: 10.1017/S0007114511006258. Epub 2011 Dec 6.
PubMed 22142517Knies S, Boonen A, Severens JL. Do the Washington Panel recommendations hold for Europe: investigating the relation between quality of life versus work-status, absenteeism and presenteeism. Cost Eff Resour Alloc. 2014 Nov 24;12:24. doi: 10.1186/1478-7547-12-24. eCollection 2014.
PubMed 25904824Robroek SJ, Polinder S, Bredt FJ, Burdorf A. Cost-effectiveness of a long-term Internet-delivered worksite health promotion programme on physical activity and nutrition: a cluster randomized controlled trial. Health Educ Res. 2012 Jun;27(3):399-410. doi: 10.1093/her/cys015. Epub 2012 Feb 20.
PubMed 22350194Kreps GL, Neuhauser L. New directions in eHealth communication: opportunities and challenges. Patient Educ Couns. 2010 Mar;78(3):329-36. doi: 10.1016/j.pec.2010.01.013. Epub 2010 Mar 3.
PubMed 20202779Tate DF, Jackvony EH, Wing RR. A randomized trial comparing human e-mail counseling, computer-automated tailored counseling, and no counseling in an Internet weight loss program. Arch Intern Med. 2006 Aug 14-28;166(15):1620-5. doi: 10.1001/archinte.166.15.1620.
PubMed 16908795Palmer KT, Harris EC, Linaker C, Barker M, Lawrence W, Cooper C, Coggon D. Effectiveness of community- and workplace-based interventions to manage musculoskeletal-related sickness absence and job loss: a systematic review. Rheumatology (Oxford). 2012 Feb;51(2):230-42. doi: 10.1093/rheumatology/ker086. Epub 2011 Mar 16.
PubMed 21415023Krukowski RA, Tilford JM, Harvey-Berino J, West DS. Comparing behavioral weight loss modalities: incremental cost-effectiveness of an internet-based versus an in-person condition. Obesity (Silver Spring). 2011 Aug;19(8):1629-35. doi: 10.1038/oby.2010.341. Epub 2011 Jan 20.
PubMed 21253001
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02980237
- Acronym / sponsor ID
- e-Health / 1.023.328
- Conditions
- Health Behavior
- Keywords
- Office workers, Quality of life, e-Learning, Occupational health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- Rosimeire Simprini PadulaUniversity, hospital or other
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 17 Oct 2017 (actual)
- Study completion
- 2 Mar 2018 (actual)
- First posted
- 2 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eHealth_additional support | Experimental | Other: eHealth_additional supportAn e-learning education program whose audiovisual content will be implemented. The course could be access in the workplace but they will be additional support. |
| eHealth | Active comparator | Other: eHealth_programThis group will receive an e-learning education program same as the intervention group . However, the participants will not receive additional support by team. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Technical-administrative workers, computer users for a minimum period of six months. ,
- Signed informed consent form
Key exclusion criteria (3 listed)
- Suspected or confirmed pregnant workers at randomization time
- Mothers what Breastfeeding
- Workers in annual leave.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eHealth_additional supportAn 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. | Other | eHealth_additional support |
| eHealth_programThe comparative group will receive the same eHealth education program that intervention group. But the comparative group will receive only audiovisuals without additional support. . | Other | eHealth |
Primary outcome
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).
3 secondary outcomes
Change from Anthropometric measure at 6 and 8 months
Time frame: 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
Change from Lifestyle at 6 and 8 months
Time frame: Baseline, 6 and 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Results publication: PubMed 21589875Andersen JH, Fallentin N, Thomsen JF, Mikkelsen S. Risk factors for neck and upper extremity disorders among computers users and the effect of interventions: an overview of systematic reviews. PLoS One. 2011 May 12;6(5):e19691. doi: 10.1371/journal.pone.0019691.
- Results publication: PubMed 12271479Dillon C, Petersen M, Tanaka S. Self-reported hand and wrist arthritis and occupation: data from the U.S. National Health Interview Survey-Occupational Health Supplement. Am J Ind Med. 2002 Oct;42(4):318-27. doi: 10.1002/ajim.10117.
- Results publication: PubMed 24990642Mulder R, Pouwelse M, Lodewijkx H, Bolman C. Workplace mobbing and bystanders' helping behaviour towards victims: the role of gender, perceived responsibility and anticipated stigma by association. Int J Psychol. 2014 Aug;49(4):304-12. doi: 10.1002/ijop.12018. Epub 2013 Nov 20.
- Results publication: PubMed 22695029Raman SR, Al-Halabi B, Hamdan E, Landry MD. Prevalence and risk factors associated with self-reported carpal tunnel syndrome (CTS) among office workers in Kuwait. BMC Res Notes. 2012 Jun 13;5:289. doi: 10.1186/1756-0500-5-289.
- Results publication: PubMed 21767729Thorp AA, Owen N, Neuhaus M, Dunstan DW. Sedentary behaviors and subsequent health outcomes in adults a systematic review of longitudinal studies, 1996-2011. Am J Prev Med. 2011 Aug;41(2):207-15. doi: 10.1016/j.amepre.2011.05.004.
- Results publication: PubMed 20429925Waersted M, Hanvold TN, Veiersted KB. Computer work and musculoskeletal disorders of the neck and upper extremity: a systematic review. BMC Musculoskelet Disord. 2010 Apr 29;11:79. doi: 10.1186/1471-2474-11-79.
- Results publication: PubMed 25480459Bernal D, Campos-Serna J, Tobias A, Vargas-Prada S, Benavides FG, Serra C. Work-related psychosocial risk factors and musculoskeletal disorders in hospital nurses and nursing aides: a systematic review and meta-analysis. Int J Nurs Stud. 2015 Feb;52(2):635-48. doi: 10.1016/j.ijnurstu.2014.11.003. Epub 2014 Nov 15.
- Results publication: PubMed 21205408Bandoni DH, Sarno F, Jaime PC. Impact of an intervention on the availability and consumption of fruits and vegetables in the workplace. Public Health Nutr. 2011 Jun;14(6):975-81. doi: 10.1017/S1368980010003460. Epub 2010 Dec 21.
- Results publication: PubMed 22142517Cash SW, Beresford SA, Henderson JA, McTiernan A, Xiao L, Wang CY, Patrick DL. Dietary and physical activity behaviours related to obesity-specific quality of life and work productivity: baseline results from a worksite trial. Br J Nutr. 2012 Sep 28;108(6):1134-42. doi: 10.1017/S0007114511006258. Epub 2011 Dec 6.
- Results publication: PubMed 25904824Knies S, Boonen A, Severens JL. Do the Washington Panel recommendations hold for Europe: investigating the relation between quality of life versus work-status, absenteeism and presenteeism. Cost Eff Resour Alloc. 2014 Nov 24;12:24. doi: 10.1186/1478-7547-12-24. eCollection 2014.
- Results publication: PubMed 22350194Robroek SJ, Polinder S, Bredt FJ, Burdorf A. Cost-effectiveness of a long-term Internet-delivered worksite health promotion programme on physical activity and nutrition: a cluster randomized controlled trial. Health Educ Res. 2012 Jun;27(3):399-410. doi: 10.1093/her/cys015. Epub 2012 Feb 20.
- Results publication: PubMed 20202779Kreps GL, Neuhauser L. New directions in eHealth communication: opportunities and challenges. Patient Educ Couns. 2010 Mar;78(3):329-36. doi: 10.1016/j.pec.2010.01.013. Epub 2010 Mar 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosimeire S Padula, PhD study director
Universidade Cidade de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eHealth_additional support and eHealth_program in people with Health Behavior, run by Rosimeire Simprini Padula at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Quality of life at 6 and 8 months (time frame: Baseline, 6 and 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02980237, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.