Focus of Study: Work ConditionsWFHSNCT02050204
Evaluating the Health Benefits of Workplace Policies and Practices - Phase II
A study testing Intervention in people with Focus of Study: Work Conditions, run by Harvard School of Public Health (HSPH) at 1 site in United States.
Trial summary
Although the prevalence of "family-friendly" policies in US workplaces has increased dramatically, few have been studied using scientifically sound designs. To address this, the NIH and CDC formed the Work, Family, and Health Network (WFHN). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Focus of Study: Work Conditions
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,753 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Dec 2012
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- LEEF: employees and supervisors with at least 22 weekly hours of direct patient care work in selected facilities
- TOMO: employees and supervisors located in the two data collection cities
Who cannot join
- LEEF: nightwork schedule
- TOMO: independent contractor classification
Trial locations and contacts
1 site in 1 country.
United States1 site
Harvard School of Public Health
Cambridge, Massachusetts, 02318
About this study
Although the prevalence of "family-friendly" policies in US workplaces has increased dramatically, few have been studied using scientifically sound designs. To address this, the NIH and CDC formed the Work, Family, and Health Network (WFHN). During Phase 1, the WFHN designed and conducted multiple pilot and feasibility studies. For Phase 2, the WFHN implemented an innovative intervention based on Phase I pilot studies that is designed to increase family-supportive supervisor behaviors and employee control over work, and to evaluate the intervention using a group randomized experimental design. Customized interventions were performed separately in workplaces of two separate corporate partners.
Read the detailed description
Although the prevalence of "family-friendly" policies in US workplaces has increased dramatically in recent years, few have been studied using scientifically sound designs. To address this critical gap, the NIH and CDC formed the Work, Family, and Health Network (WFHN). During Phase 1, the WFHN designed and conducted multiple pilot and feasibility studies.
For Phase 2, the WFHN implemented an innovative intervention based on Phase 1 pilot studies that is designed to increase family-supportive supervisor behaviors and employee control over work, and to evaluate the intervention using a group randomized experimental design. The goal of the study is to assess the effects of a workplace intervention designed to reduce work-family conflict, and thereby improve the health and well being of employees. The study intervention is grounded in theory from multiple disciplines and supported by findings from pilot/feasibility studies. The study seeks to inform the implementation of evidence-based, family-friendly policies, and thereby improving the health and well-being of employees and their families nationwide.
The investigators assess the efficacy of the intervention via two independent, group-randomized field experiments, one at each of two employers representing different industries, referred to by alias as "LEEF" and "TOMO". LEEF is an extended care (nursing home) company and facilities were excluded if they were in very isolated settings, if there were fewer than 30 direct patient-care employees, or if facilities were recently acquired. TOMO is an Information Technology company. Within each industry partner, worksites of 50-120 employees each were randomly assigned to intervention or usual practice conditions. All employee and supervisor participants were assessed at baseline and at 6-, 12-, and 18-months post baseline, including survey interviews and health assessments.
Primary health outcomes were comprised of a cardiometabolic risk score using selected biomarkers and sleep duration and quality objectively measured using wrist actigraphy. These primary health outcomes were independently assessed as change from baseline to the 12-month wave, and separately in the two industries.
- Conditions
- Focus of Study: Work Conditions
- Being tested
- Intervention
- Keywords
- work to family conflict, supervisor support, long work hours, cardiometabolic risk, sleep duration, insomnia symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
The intervention was a 3-month structural and social change process designed to increase employee control over work time and family supportive supervisory behaviors (Kossek et al., in press). The change process was an integration of two previously evaluated interventions (Hammer et al., 2011; Kelly et al., 2011). A facilitator led 8 hrs of participatory sessions to transition employees from a time-based to a results-based work culture. Supervisors participated in all change activities plus 4hrs of training in supportive supervision. Training in family supportive supervision was implemented with behavioral computer-based training (cTRAIN, NWeta, Lake Oswego, OR) followed by 2 rounds of goal-setting and behavioral self-monitoring using an iPod Touch (Habitrack, OHSU, Portland, OR).
| Study group | Role | What they receive |
|---|---|---|
| LEEF Industry only: Intervention | Experimental | Customized to the "Leef" (alias) workplace: A 3-month structural and social change process designed to increase employee control over work time and family supportive supervisory behaviors. Receives: Behavioral: Intervention |
| LEEF Industry only: Usual Practice | No intervention | Continued work conditions and practice as "Usual Practice" in that workplace |
| TOMO Industry only: Intervention | Experimental | Customized to the "Tomo" (alias) workplace: A 3-month structural and social change process designed to increase employee control over work time and family supportive supervisory behaviors. Receives: Behavioral: Intervention |
| TOMO Industry only: Usual Practice | No intervention | Continued work conditions and practice as "Usual Practice" in that workplace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total sleep time
Average 24 hour total sleep time as assessed by ~1 week of actigraphy
Measured: baseline to one year later
change in wake after sleep onset
Amount of nightime wake after sleep onset as assessed by ~1 week of actigraphy
Measured: baseline to one year later
change in cardiometabolic risk score
The cardiometabolic risk score was created based on modifiable risk factors using an independently validated CVD risk score developed from the Framingham offspring study; including BMI, blood pressure, HbA1C, cholesterol, and tobacco consumption.
Measured: baseline to one year later
Secondary outcomes (2)
change in sleep insufficiency
Sleep insufficiency was assessed by the following question: How often during the past 4 weeks did you get enough sleep to feel rested upon waking up? Would you say never, rarely, sometimes, often, or very often?
YES - NEVER/RARELY
NO - SOMETIMES OFTEN VERY OFTEN
Measured: baseline to one year later
change in insomnia symptoms
Insomnia symptoms were assessed by the following question: During the past 4 weeks, how often did you wake up in the middle of the night or early morning? (Would you say never, less than once a week, once or twice a week, or three or more times a week?)
YES - THREE OR MORE TIMES A WEEK
NO - NEVER/LESS THAN ONCE A WEEK/ONCE OR TWICE A WEEK
Measured: baseline to one year later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startSep 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Focus of Study: Work ConditionsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 2,753 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Heart, Lung, and Blood Institute (NHLBI), Office of Behavioral and Social Sciences Research (OBSSR), National Institute for Occupational Safety and Health (NIOSH/CDC)
- Responsible party
- Principal investigator, Lisa Berkman, Harvard School of Public Health (HSPH)
- Investigators
- Lisa F Berkman, PhD, Principal investigator, Harvard School of Public Health (HSPH)Orfeu M Buxton, PhD, Principal investigator, Brigham and Women's Hospital; Harvard Medical School; Harvard School of Public Health; Pennsylvania State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02050204
- Sponsor's protocol ID
- P16633
- Other IDs
- U01AG027669, U01HD051218, U01HD051256, U01HD051276, U01HD051217, R01HL107240, U01OH008788, U01HD059773
- Acronym
- WFHS
- Status last verified
- Dec 2017
- First submitted
- 28 Jan 2014
- Last updated
- 15 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Okechukwu CA, Souza K, Davis KD, de Castro AB. Discrimination, harassment, abuse, and bullying in the workplace: contribution of workplace injustice to occupational health disparities. Am J Ind Med. 2014 May;57(5):573-86. doi: 10.1002/ajim.22221. Epub 2013 Jun 27.
PubMed 23813664Hammer LB, Ernst Kossek E, Bodner T, Crain T. Measurement development and validation of the Family Supportive Supervisor Behavior Short-Form (FSSB-SF). J Occup Health Psychol. 2013 Jul;18(3):285-96. doi: 10.1037/a0032612. Epub 2013 Jun 3.
PubMed 23730803Liu S, Rovine MJ, Klein LC, Almeida DM. Synchrony of diurnal cortisol pattern in couples. J Fam Psychol. 2013 Aug;27(4):579-88. doi: 10.1037/a0033735.
PubMed 23978320Cunningham TJ, Seeman TE, Kawachi I, Gortmaker SL, Jacobs DR, Kiefe CI, Berkman LF. Racial/ethnic and gender differences in the association between self-reported experiences of racial/ethnic discrimination and inflammation in the CARDIA cohort of 4 US communities. Soc Sci Med. 2012 Sep;75(5):922-31. doi: 10.1016/j.socscimed.2012.04.027. Epub 2012 May 23.
PubMed 22682683O'Donnell EM, Berkman LF, Subramanian SV. Manager support for work-family issues and its impact on employee-reported pain in the extended care setting. J Occup Environ Med. 2012 Sep;54(9):1142-9. doi: 10.1097/JOM.0b013e3182554af4.
PubMed 22892547Nelson CC, Li Y, Sorensen G, Berkman LF. Assessing the relationship between work-family conflict and smoking. Am J Public Health. 2012 Sep;102(9):1767-72. doi: 10.2105/AJPH.2011.300413. Epub 2012 Jun 21.
PubMed 22720765Hurtado DA, Sabbath EL, Ertel KA, Buxton OM, Berkman LF. Racial disparities in job strain among American and immigrant long-term care workers. Int Nurs Rev. 2012 Jun;59(2):237-44. doi: 10.1111/j.1466-7657.2011.00948.x. Epub 2011 Dec 7.
PubMed 22591096Sembajwe G, Wahrendorf M, Siegrist J, Sitta R, Zins M, Goldberg M, Berkman L. Effects of job strain on fatigue: cross-sectional and prospective views of the job content questionnaire and effort--reward imbalance in the GAZEL cohort. Occup Environ Med. 2012 Jun;69(6):377-84. doi: 10.1136/oem.2010.063503. Epub 2011 Aug 17.
PubMed 21849345Wahrendorf M, Sembajwe G, Zins M, Berkman L, Goldberg M, Siegrist J. Long-term effects of psychosocial work stress in midlife on health functioning after labor market exit--results from the GAZEL study. J Gerontol B Psychol Sci Soc Sci. 2012 Jul;67(4):471-80. doi: 10.1093/geronb/gbs045. Epub 2012 Apr 29.
PubMed 22546992Okechukwu CA, El Ayadi AM, Tamers SL, Sabbath EL, Berkman L. Household food insufficiency, financial strain, work-family spillover, and depressive symptoms in the working class: the Work, Family, and Health Network study. Am J Public Health. 2012 Jan;102(1):126-33. doi: 10.2105/AJPH.2011.300323. Epub 2011 Nov 28.
PubMed 22095360Sabbath EL, Melchior M, Goldberg M, Zins M, Berkman LF. Work and family demands: predictors of all-cause sickness absence in the GAZEL cohort. Eur J Public Health. 2012 Feb;22(1):101-6. doi: 10.1093/eurpub/ckr041. Epub 2011 May 9.
PubMed 21558153McHale SM, Blocklin MK, Walter KN, Davis KD, Almeida DM, Klein LC. The role of daily activities in youths' stress physiology. J Adolesc Health. 2012 Dec;51(6):623-8. doi: 10.1016/j.jadohealth.2012.03.016. Epub 2012 May 16.
PubMed 23174474Blocklin MK, Crouter AC, McHale SM. Youth Supervision While Mothers Work: A Daily Diary Study of Maternal Worry. Community Work Fam. 2012;15(2):233-249. doi: 10.1080/13668803.2011.639169. Epub 2011 Dec 2.
PubMed 23109814Almeida DM, Davis KD. Workplace Flexibility and Daily Stress Processes in Hotel Employees and their Children. Ann Am Acad Pol Soc Sci. 2011 Nov;638(1):123-140. doi: 10.1177/0002716211415608.
PubMed 23833321Hammer LB, Kossek EE, Anger WK, Bodner T, Zimmerman KL. Clarifying work-family intervention processes: the roles of work-family conflict and family-supportive supervisor behaviors. J Appl Psychol. 2011 Jan;96(1):134-50. doi: 10.1037/a0020927.
PubMed 20853943
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Health Benefits of Workplace Policies and Practices - Phase II
- ClinicalTrials.gov ID
- NCT02050204
- Acronym / sponsor ID
- WFHS / P16633
- Conditions
- Focus of Study: Work Conditions
- Keywords
- work to family conflict, supervisor support, long work hours, cardiometabolic risk, sleep duration, insomnia symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,753 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Heart, Lung, and Blood Institute (NHLBI), Office of Behavioral and Social Sciences Research (OBSSR), National Institute for Occupational Safety and Health (NIOSH/CDC)
- Study start
- Sep 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 30 Jan 2014 (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.
Although the prevalence of "family-friendly" policies in US workplaces has increased dramatically, few have been studied using scientifically sound designs. To address this, the NIH and CDC formed the Work, Family, and Health Network (WFHN). During Phase 1, the WFHN designed and conducted multiple pilot and feasibility studies. For Phase 2, the WFHN implemented an innovative intervention based on Phase I pilot studies that is designed to increase family-supportive supervisor behaviors and employee control over work, and to evaluate the intervention using a group randomized experimental design. Customized interventions were performed separately in workplaces of two separate corporate partners.
Detailed description
Although the prevalence of "family-friendly" policies in US workplaces has increased dramatically in recent years, few have been studied using scientifically sound designs. To address this critical gap, the NIH and CDC formed the Work, Family, and Health Network (WFHN). During Phase 1, the WFHN designed and conducted multiple pilot and feasibility studies.
For Phase 2, the WFHN implemented an innovative intervention based on Phase 1 pilot studies that is designed to increase family-supportive supervisor behaviors and employee control over work, and to evaluate the intervention using a group randomized experimental design. The goal of the study is to assess the effects of a workplace intervention designed to reduce work-family conflict, and thereby improve the health and well being of employees. The study intervention is grounded in theory from multiple disciplines and supported by findings from pilot/feasibility studies. The study seeks to inform the implementation of evidence-based, family-friendly policies, and thereby improving the health and well-being of employees and their families nationwide.
The investigators assess the efficacy of the intervention via two independent, group-randomized field experiments, one at each of two employers representing different industries, referred to by alias as "LEEF" and "TOMO". LEEF is an extended care (nursing home) company and facilities were excluded if they were in very isolated settings, if there were fewer than 30 direct patient-care employees, or if facilities were recently acquired. TOMO is an Information Technology company. Within each industry partner, worksites of 50-120 employees each were randomly assigned to intervention or usual practice conditions. All employee and supervisor participants were assessed at baseline and at 6-, 12-, and 18-months post baseline, including survey interviews and health assessments.
Primary health outcomes were comprised of a cardiometabolic risk score using selected biomarkers and sleep duration and quality objectively measured using wrist actigraphy. These primary health outcomes were independently assessed as change from baseline to the 12-month wave, and separately in the two industries.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LEEF Industry only: Intervention | Experimental | Behavioral: InterventionCustomized to the "Leef" (alias) workplace: A 3-month structural and social change process designed to increase employee control over work time and family supportive supervisory behaviors. |
| LEEF Industry only: Usual Practice | No intervention | –Continued work conditions and practice as "Usual Practice" in that workplace |
| TOMO Industry only: Intervention | Experimental | Behavioral: InterventionCustomized to the "Tomo" (alias) workplace: A 3-month structural and social change process designed to increase employee control over work time and family supportive supervisory behaviors. |
| TOMO Industry only: Usual Practice | No intervention | –Continued work conditions and practice as "Usual Practice" in that workplace |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- LEEF: employees and supervisors with at least 22 weekly hours of direct patient care work in selected facilities
- TOMO: employees and supervisors located in the two data collection cities
Key exclusion criteria (2 listed)
- LEEF: nightwork schedule
- TOMO: independent contractor classification
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 |
|---|---|---|
| InterventionThe intervention was a 3-month structural and social change process designed to increase employee control over work time and family supportive supervisory behaviors (Kossek et al., in press). The change process was an integration of two previously evaluated interventions (Hammer et al., 2011; Kelly et al., 2011). A facilitator led 8 hrs of participatory sessions to transition employees from a time-based to a results-based work culture. Supervisors participated in all change activities plus 4hrs of training in supportive supervision. Training in family supportive supervision was implemented with behavioral computer-based training (cTRAIN, NWeta, Lake Oswego, OR) followed by 2 rounds of goal-setting and behavioral self-monitoring using an iPod Touch (Habitrack, OHSU, Portland, OR). | Behavioural | LEEF Industry only: Intervention, TOMO Industry only: Intervention |
Primary outcome
Change in total sleep time
Time frame: baseline to one year later
Average 24 hour total sleep time as assessed by ~1 week of actigraphy
change in wake after sleep onset
Time frame: baseline to one year later
Amount of nightime wake after sleep onset as assessed by ~1 week of actigraphy
change in cardiometabolic risk score
Time frame: baseline to one year later
The cardiometabolic risk score was created based on modifiable risk factors using an independently validated CVD risk score developed from the Framingham offspring study; including BMI, blood pressure, HbA1C, cholesterol, and tobacco consumption.
2 secondary outcomes
change in sleep insufficiency
Time frame: baseline to one year later
change in insomnia symptoms
Time frame: baseline to one year later
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 15 Dec 2017.
- Background: PubMed 23813664Okechukwu CA, Souza K, Davis KD, de Castro AB. Discrimination, harassment, abuse, and bullying in the workplace: contribution of workplace injustice to occupational health disparities. Am J Ind Med. 2014 May;57(5):573-86. doi: 10.1002/ajim.22221. Epub 2013 Jun 27.
- Background: PubMed 23730803Hammer LB, Ernst Kossek E, Bodner T, Crain T. Measurement development and validation of the Family Supportive Supervisor Behavior Short-Form (FSSB-SF). J Occup Health Psychol. 2013 Jul;18(3):285-96. doi: 10.1037/a0032612. Epub 2013 Jun 3.
- Background: PubMed 23978320Liu S, Rovine MJ, Klein LC, Almeida DM. Synchrony of diurnal cortisol pattern in couples. J Fam Psychol. 2013 Aug;27(4):579-88. doi: 10.1037/a0033735.
- Background: PubMed 22682683Cunningham TJ, Seeman TE, Kawachi I, Gortmaker SL, Jacobs DR, Kiefe CI, Berkman LF. Racial/ethnic and gender differences in the association between self-reported experiences of racial/ethnic discrimination and inflammation in the CARDIA cohort of 4 US communities. Soc Sci Med. 2012 Sep;75(5):922-31. doi: 10.1016/j.socscimed.2012.04.027. Epub 2012 May 23.
- Background: PubMed 22892547O'Donnell EM, Berkman LF, Subramanian SV. Manager support for work-family issues and its impact on employee-reported pain in the extended care setting. J Occup Environ Med. 2012 Sep;54(9):1142-9. doi: 10.1097/JOM.0b013e3182554af4.
- Background: PubMed 22720765Nelson CC, Li Y, Sorensen G, Berkman LF. Assessing the relationship between work-family conflict and smoking. Am J Public Health. 2012 Sep;102(9):1767-72. doi: 10.2105/AJPH.2011.300413. Epub 2012 Jun 21.
- Background: PubMed 22591096Hurtado DA, Sabbath EL, Ertel KA, Buxton OM, Berkman LF. Racial disparities in job strain among American and immigrant long-term care workers. Int Nurs Rev. 2012 Jun;59(2):237-44. doi: 10.1111/j.1466-7657.2011.00948.x. Epub 2011 Dec 7.
- Background: PubMed 21849345Sembajwe G, Wahrendorf M, Siegrist J, Sitta R, Zins M, Goldberg M, Berkman L. Effects of job strain on fatigue: cross-sectional and prospective views of the job content questionnaire and effort--reward imbalance in the GAZEL cohort. Occup Environ Med. 2012 Jun;69(6):377-84. doi: 10.1136/oem.2010.063503. Epub 2011 Aug 17.
- Background: PubMed 22546992Wahrendorf M, Sembajwe G, Zins M, Berkman L, Goldberg M, Siegrist J. Long-term effects of psychosocial work stress in midlife on health functioning after labor market exit--results from the GAZEL study. J Gerontol B Psychol Sci Soc Sci. 2012 Jul;67(4):471-80. doi: 10.1093/geronb/gbs045. Epub 2012 Apr 29.
- Background: PubMed 22095360Okechukwu CA, El Ayadi AM, Tamers SL, Sabbath EL, Berkman L. Household food insufficiency, financial strain, work-family spillover, and depressive symptoms in the working class: the Work, Family, and Health Network study. Am J Public Health. 2012 Jan;102(1):126-33. doi: 10.2105/AJPH.2011.300323. Epub 2011 Nov 28.
- Background: PubMed 21558153Sabbath EL, Melchior M, Goldberg M, Zins M, Berkman LF. Work and family demands: predictors of all-cause sickness absence in the GAZEL cohort. Eur J Public Health. 2012 Feb;22(1):101-6. doi: 10.1093/eurpub/ckr041. Epub 2011 May 9.
- Background: PubMed 23174474McHale SM, Blocklin MK, Walter KN, Davis KD, Almeida DM, Klein LC. The role of daily activities in youths' stress physiology. J Adolesc Health. 2012 Dec;51(6):623-8. doi: 10.1016/j.jadohealth.2012.03.016. Epub 2012 May 16.
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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.
Lisa F Berkman, PhD principal investigator
Harvard School of Public Health (HSPH)
Orfeu M Buxton, PhD principal investigator
Brigham and Women's Hospital; Harvard Medical School; Harvard School of Public Health; Pennsylvania State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Focus of Study: Work Conditions, run by Harvard School of Public Health (HSPH) at 1 site in United States.
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 2 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 15 Dec 2017. 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 United States. 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 in total sleep time (time frame: baseline to one year later). The study lists 3 primary outcomes in all. 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 NCT02050204, which also lists 25 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 15 Dec 2017.