- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03164330
Illinois Workplace Wellness Study
Study Overview
Status
Conditions
Intervention / Treatment
- Behavioral: Workplace Wellness Program
- Behavioral: Biometric Screening/HRA - No Compensation
- Behavioral: Wellness Activities - Low Compensation
- Behavioral: Wellness Activities - High Compensation
- Behavioral: Biometric Screening/HRA - Moderate Compensation
- Behavioral: Biometric Screening/HRA - High Compensation
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60605
- University of Chicago
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Benefits eligible employees at UIUC. Physically located on UIUC campus, not terminated, eligible for benefits.
Exclusion Criteria:
- Members of the research team, employees directly involved with the approval or implementation of the study, family members of the research team.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
The control group takes a baseline survey, and thereafter has minimal interaction with the project, until a follow-up biometric screening is conducted during the one-year follow-up.
|
|
Experimental: A25
Group A25 is offered no compensation for completing a biometric screening and HRA, and low compensation for each completed wellness course in the fall or spring of the study. Interventions: Workplace Wellness Program, Biometric Screening/HRA - No compensation, Wellness Activities - low compensation |
Treatment group members will then be offered the opportunity to participate in a biometric screening and health risk assessment (biometric screening + HRA), and -- conditional on completing an biometric screening + HRA -- up to two, semester-long wellness programs.
Treatment group members will be offered varying levels of cash reward for completing the biometric screening + HRA (none, moderate, high), and an additional cash reward for completing each wellness activity (low, high), for a total of 6 treatment cells.
Follow-up surveys and biometric screenings will be administered one year later, among a subset of control and treatment group members.
Other Names:
The biometric test will measure: (1) anthropometrics such as height, weight, and waist circumference (to assess obesity and overweight status); (2) resting blood pressure (to assess hypertension); (3) blood glucose (to assess diabetes risk); and (4) total, LDL, and HDL cholesterol levels, total cholesterol ratio, and triglycerides (to assess risk of cardiovascular disease).
The HRA is a survey designed to identify areas of health improvement, by asking a series of questions related to wellness, health status, nutrition, healthy activities, desire to improve health, preventative health measures.
The HRA is also pre-populated with biometric information from the screening.
Upon completion, participants are given customized feedback on areas of improvement.
No compensation for completion.
Courses are designed by the UI Wellness Center and include an Active Living class; self-paced online health challenges in physical activity, weight management, and healthy eating; a weight management class; a tobacco cessation hotline; a stress management class; a Tai Chi class; and a chronic disease management class.
Low compensation for each class.
|
Experimental: A75
Group A75 is offered no compensation for completing a biometric screening and HRA, and high compensation for each completed wellness course in the fall or spring of the study. Interventions: Workplace Wellness Program, Biometric Screening/HRA - No compensation, Wellness Activities - high compensation |
Treatment group members will then be offered the opportunity to participate in a biometric screening and health risk assessment (biometric screening + HRA), and -- conditional on completing an biometric screening + HRA -- up to two, semester-long wellness programs.
Treatment group members will be offered varying levels of cash reward for completing the biometric screening + HRA (none, moderate, high), and an additional cash reward for completing each wellness activity (low, high), for a total of 6 treatment cells.
Follow-up surveys and biometric screenings will be administered one year later, among a subset of control and treatment group members.
Other Names:
The biometric test will measure: (1) anthropometrics such as height, weight, and waist circumference (to assess obesity and overweight status); (2) resting blood pressure (to assess hypertension); (3) blood glucose (to assess diabetes risk); and (4) total, LDL, and HDL cholesterol levels, total cholesterol ratio, and triglycerides (to assess risk of cardiovascular disease).
The HRA is a survey designed to identify areas of health improvement, by asking a series of questions related to wellness, health status, nutrition, healthy activities, desire to improve health, preventative health measures.
The HRA is also pre-populated with biometric information from the screening.
Upon completion, participants are given customized feedback on areas of improvement.
No compensation for completion.
Courses are designed by the UI Wellness Center and include an Active Living class; self-paced online health challenges in physical activity, weight management, and healthy eating; a weight management class; a tobacco cessation hotline; a stress management class; a Tai Chi class; and a chronic disease management class.
High compensation for each class.
|
Experimental: B25
Group B25 is offered moderate compensation for completing a biometric screening and HRA, and low compensation for each completed wellness course in the fall or spring of the study. Interventions: Workplace Wellness Program, Biometric Screening/HRA - moderate compensation, Wellness Activities - high compensation |
Treatment group members will then be offered the opportunity to participate in a biometric screening and health risk assessment (biometric screening + HRA), and -- conditional on completing an biometric screening + HRA -- up to two, semester-long wellness programs.
Treatment group members will be offered varying levels of cash reward for completing the biometric screening + HRA (none, moderate, high), and an additional cash reward for completing each wellness activity (low, high), for a total of 6 treatment cells.
Follow-up surveys and biometric screenings will be administered one year later, among a subset of control and treatment group members.
Other Names:
Courses are designed by the UI Wellness Center and include an Active Living class; self-paced online health challenges in physical activity, weight management, and healthy eating; a weight management class; a tobacco cessation hotline; a stress management class; a Tai Chi class; and a chronic disease management class.
Low compensation for each class.
The biometric test will measure: (1) anthropometrics such as height, weight, & waist circumference (to assess obesity and overweight status); (2) resting blood pressure (to assess hypertension); (3) blood glucose (to assess diabetes risk); & (4) total, LDL, and HDL cholesterol levels, total cholesterol ratio, and triglycerides (to assess risk of cardiovascular disease).
The HRA is a survey designed to identify areas of health improvement, by asking a series of questions related to wellness, health status, nutrition, healthy activities, desire to improve health, preventative health measures.
The HRA is also pre-populated with biometric information from the screening.
Upon completion, participants are given customized feedback on areas of improvement.
Moderate compensation for completion.
|
Experimental: B75
Group B75 is offered moderate compensation for completing a biometric screening and HRA, and high compensation for each completed wellness course in the fall or spring of the study. Interventions: Workplace Wellness Program, Biometric Screening/HRA - moderate compensation, Wellness Activities - high compensation |
Treatment group members will then be offered the opportunity to participate in a biometric screening and health risk assessment (biometric screening + HRA), and -- conditional on completing an biometric screening + HRA -- up to two, semester-long wellness programs.
Treatment group members will be offered varying levels of cash reward for completing the biometric screening + HRA (none, moderate, high), and an additional cash reward for completing each wellness activity (low, high), for a total of 6 treatment cells.
Follow-up surveys and biometric screenings will be administered one year later, among a subset of control and treatment group members.
Other Names:
Courses are designed by the UI Wellness Center and include an Active Living class; self-paced online health challenges in physical activity, weight management, and healthy eating; a weight management class; a tobacco cessation hotline; a stress management class; a Tai Chi class; and a chronic disease management class.
High compensation for each class.
The biometric test will measure: (1) anthropometrics such as height, weight, & waist circumference (to assess obesity and overweight status); (2) resting blood pressure (to assess hypertension); (3) blood glucose (to assess diabetes risk); & (4) total, LDL, and HDL cholesterol levels, total cholesterol ratio, and triglycerides (to assess risk of cardiovascular disease).
The HRA is a survey designed to identify areas of health improvement, by asking a series of questions related to wellness, health status, nutrition, healthy activities, desire to improve health, preventative health measures.
The HRA is also pre-populated with biometric information from the screening.
Upon completion, participants are given customized feedback on areas of improvement.
Moderate compensation for completion.
|
Experimental: C25
Group C25 is offered high compensation for completing a biometric screening and HRA, and low compensation for each completed wellness course in the fall or spring of the study. Interventions: Workplace Wellness Program, Biometric Screening/HRA - high compensation, Wellness Activities - high compensation |
Treatment group members will then be offered the opportunity to participate in a biometric screening and health risk assessment (biometric screening + HRA), and -- conditional on completing an biometric screening + HRA -- up to two, semester-long wellness programs.
Treatment group members will be offered varying levels of cash reward for completing the biometric screening + HRA (none, moderate, high), and an additional cash reward for completing each wellness activity (low, high), for a total of 6 treatment cells.
Follow-up surveys and biometric screenings will be administered one year later, among a subset of control and treatment group members.
Other Names:
Courses are designed by the UI Wellness Center and include an Active Living class; self-paced online health challenges in physical activity, weight management, and healthy eating; a weight management class; a tobacco cessation hotline; a stress management class; a Tai Chi class; and a chronic disease management class.
Low compensation for each class.
The biometric test will measure: (1) anthropometrics such as height, weight, and waist circumference (to assess obesity and overweight status); (2) resting blood pressure (to assess hypertension); (3) blood glucose (to assess diabetes risk); and (4) total, LDL, and HDL cholesterol levels, total cholesterol ratio, and triglycerides (to assess risk of cardiovascular disease).
The HRA is a survey designed to identify areas of health improvement, by asking a series of questions related to wellness, health status, nutrition, healthy activities, desire to improve health, preventative health measures.
The HRA is also pre-populated with biometric information from the screening.
Upon completion, participants are given customized feedback on areas of improvement.
High compensation for completion.
|
Experimental: C75
Group C75 is offered high compensation for completing a biometric screening and HRA, and high compensation for each completed wellness course in the fall or spring of the study. Interventions: Workplace Wellness Program, Biometric Screening/HRA - high compensation Wellness Activities - high compensation |
Treatment group members will then be offered the opportunity to participate in a biometric screening and health risk assessment (biometric screening + HRA), and -- conditional on completing an biometric screening + HRA -- up to two, semester-long wellness programs.
Treatment group members will be offered varying levels of cash reward for completing the biometric screening + HRA (none, moderate, high), and an additional cash reward for completing each wellness activity (low, high), for a total of 6 treatment cells.
Follow-up surveys and biometric screenings will be administered one year later, among a subset of control and treatment group members.
Other Names:
Courses are designed by the UI Wellness Center and include an Active Living class; self-paced online health challenges in physical activity, weight management, and healthy eating; a weight management class; a tobacco cessation hotline; a stress management class; a Tai Chi class; and a chronic disease management class.
High compensation for each class.
The biometric test will measure: (1) anthropometrics such as height, weight, and waist circumference (to assess obesity and overweight status); (2) resting blood pressure (to assess hypertension); (3) blood glucose (to assess diabetes risk); and (4) total, LDL, and HDL cholesterol levels, total cholesterol ratio, and triglycerides (to assess risk of cardiovascular disease).
The HRA is a survey designed to identify areas of health improvement, by asking a series of questions related to wellness, health status, nutrition, healthy activities, desire to improve health, preventative health measures.
The HRA is also pre-populated with biometric information from the screening.
Upon completion, participants are given customized feedback on areas of improvement.
High compensation for completion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wellness Program participation
Time Frame: First year of study
|
Completion of biometric screening, HRA, wellness activities
|
First year of study
|
Wellness Program participation
Time Frame: Second year of study
|
Completion of biometric screening, HRA, wellness activities
|
Second year of study
|
Selection into treatment by baseline health spending
Time Frame: 13 months prior to study
|
The investigators will compare the average observable characteristics of participants, relative to treatment non-participants.
Average monthly spending prior to the intervention is measured via administrative health claims data.
|
13 months prior to study
|
Selection into treatment by self-reported health
Time Frame: Baseline measure
|
The investigators will compare the average observable characteristics of participants, relative to treatment non-participants.
Self-reported health is measured as excellent, good, average, or poor.
|
Baseline measure
|
Selection into treatment by gender
Time Frame: Baseline measure
|
The investigators will compare the average observable characteristics of participants, relative to treatment non-participants.
Gender is measured in administrative HR records.
|
Baseline measure
|
Selection into treatment by Age
Time Frame: Baseline measure
|
The investigators will compare the average observable characteristics of participants, relative to treatment non-participants.
Age is grouped into three categories: younger than 37, age 37 to 49, age 50 or higher.
|
Baseline measure
|
Selection into treatment by race
Time Frame: Baseline measure
|
The investigators will compare the average observable characteristics of participants, relative to treatment non-participants.
Race is measure via administrative HR records, as white or nonwhite.
|
Baseline measure
|
Selection into treatment by salary quartile
Time Frame: Baseline measure
|
The investigators will compare the average observable characteristics of participants, relative to treatment non-participants.
Salary, measured by administrative HR records, is coded into 1st, 2nd, 3rd, and 4th quartile.
|
Baseline measure
|
Selection into treatment by self-reported health utilization
Time Frame: Baseline measure
|
The investigators will compare the average observable characteristics of participants, relative to treatment non-participants.
Health care utilization is measured by survey, with yes/no variable for: ever having been screened, prescription drug use, physician/ER visit in prior year, hospital visit in the past year.
|
Baseline measure
|
Selection into treatment by smoking status
Time Frame: Baseline measure
|
The investigators will compare the average observable characteristics of participants, relative to treatment non-participants.
Smoking status is measured via survey, with yes/no variables for: current smoker of cigarettes, current smoker of other product, former smoker, never smoker.
|
Baseline measure
|
Selection into treatment by chronic condition
Time Frame: Baseline measure
|
The investigators will compare the average observable characteristics of participants, relative to treatment non-participants.
Chronic condition is measured via baseline survey, and coded as a yes/no variable.
|
Baseline measure
|
Health Insurance Spending
Time Frame: 12 months and 24-30 months following study
|
Spending as measured in health insurance claims data
|
12 months and 24-30 months following study
|
Employment and Productivity
Time Frame: 12 months and 24-30 months following study
|
Promotion, job termination, sick leave, attitude toward management, index of these variables
|
12 months and 24-30 months following study
|
Health Status and Behaviors
Time Frame: 12 months and 24-30 months following study
|
Marathon participation, gym visits, health screening
|
12 months and 24-30 months following study
|
Height
Time Frame: 1 year following study, 2 years following study
|
Biometric health measures collected one year after study.
Height is measured in feet and inches.
|
1 year following study, 2 years following study
|
Weight
Time Frame: 1 year following study, 2 years following study
|
Biometric health measures collected one year after study.
Weight is measured in pounds and ounces.
|
1 year following study, 2 years following study
|
Waist circumference
Time Frame: 1 year following study, 2 years following study
|
Biometric health measures collected one year after study.
Circumference is measured in inches.
|
1 year following study, 2 years following study
|
Resting blood pressure
Time Frame: 1 year following study, 2 years following study
|
Biometric health measures collected one year after study.
Blood pressure is measured in mm Hg.
|
1 year following study, 2 years following study
|
Blood glucose
Time Frame: 1 year following study, 2 years following study
|
Biometric health measures collected one year after study.
Blood glucose is measured in mg/dL.
|
1 year following study, 2 years following study
|
Cholesterol levels
Time Frame: 1 year following study, 2 years following study
|
Biometric health measures collected one year after study.
Cholesterol is measured mg/dL.
We measure lipids: LDL, HDL, and triglycerides.
|
1 year following study, 2 years following study
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Damon Jones, PhD, University of Chicago
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 0008
- R01AG050701 (U.S. NIH Grant/Contract)
- 73730 (Other Grant/Funding Number: Robert Wood Johnson Foundation)
- 2016-06638 (Other Grant/Funding Number: Abdul Latif Jameel Poverty Action Lab)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Employee Health and Well-being
-
UConn HealthNational Institute for Occupational Safety and Health (NIOSH/CDC)Enrolling by invitationOccupational Health | Participatory Action Research | Educator Well-being | Employee HealthUnited States
-
Oregon Health and Science UniversityPortland State UniversityActive, not recruiting
-
Universidad Católica de la Santísima ConcepciónUniversidad de ConcepcionNot yet recruitingMental Health | Psychological Well-Being
-
AdventHealthCompletedHealth Behavior | Well BeingUnited States
-
University of SussexSussex Mindfulness CentreCompletedMental Health and General Well-being
-
University of Eastern FinlandVTT Technical Research Centre of Finland; City of Kuopio; Savonia University... and other collaboratorsCompleted
-
Oregon Health and Science UniversityUnited States Department of Defense; Colorado State University; Portland State...CompletedSleep | Health Behavior | Well-BeingUnited States
-
University College DublinIrish Research CouncilCompletedGeneral Mental Health and Well-BeingIreland
-
Harvard School of Public Health (HSPH)Boston University; University of California, Berkeley; University of California... and other collaboratorsRecruitingTargeting Access and Knowledge of Earned Income Tax Credit (EITC) Utilization and Policies (TAKE-UP)Well-being | Mental Health Issue | Food SecurityUnited States
-
University of BucharestRecruitingMental Health Wellness 1 | Well-Being, PsychologicalRomania
Clinical Trials on Workplace Wellness Program
-
Harvard School of Public Health (HSPH)University of Chicago; National Institute on Aging (NIA); Abdul Latif Jameel... and other collaboratorsCompletedHealth Behavior | Disease, Chronic
-
UConn HealthNational Institute for Occupational Safety and Health (NIOSH/CDC)Enrolling by invitationOccupational Health | Participatory Action Research | Educator Well-being | Employee HealthUnited States
-
Federal University of São PauloFundação de Amparo à Pesquisa do Estado de São PauloCompletedObesity | SchizophreniaBrazil
-
Hacettepe UniversityCompletedPain | Fatigue | Work-Related Stress Disorder | Nurses
-
Mayo ClinicCompletedInflammatory Bowel Diseases | Crohn Disease | Ulcerative ColitisUnited States
-
Stockholm UniversityLinkoeping UniversityCompleted
-
University of Massachusetts, LowellNational Institute for Occupational Safety and Health (NIOSH/CDC)UnknownMusculoskeletal Pain | Work-related Injury | Work-Related Condition | Burnout, Caregiver
-
Rutgers, The State University of New JerseyAgency for Healthcare Research and Quality (AHRQ)Active, not recruitingParenting | Health Behavior | Language Development | LiteracyUnited States
-
Kwantlen Polytechnic UniversityCentre for Aging and Brain Health Innovation; ABI Wellness Inc; Watson Centre...UnknownMild Cognitive Impairment
-
Virginia Commonwealth UniversityNational Institute on Minority Health and Health Disparities (NIMHD); Pathways-VA...Terminated