Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2026-01-11 @ 1:36 AM
Study NCT ID:
NCT03167658
Status:
COMPLETED
Last Update Posted:
2021-09-09
First Post:
2017-05-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Employee Wellness Programs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D002908', 'term': 'Chronic Disease'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-07', 'size': 1342913, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-01-08T20:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Each worksite (and all employees at that site) randomly assigned to Treatment or Control arm.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48664}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-07', 'studyFirstSubmitDate': '2017-05-23', 'studyFirstSubmitQcDate': '2017-05-24', 'lastUpdatePostDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Blood pressure', 'timeFrame': 'Primary data collected at 18 months and 30 months after initiation of intervention', 'description': 'Systolic blood pressure, measured'}, {'measure': 'Depression', 'timeFrame': 'Primary data collected at 18 months and 30 months after initiation of intervention', 'description': 'Unmanaged depression, as indicated in responses to survey questions'}, {'measure': 'Tenure', 'timeFrame': 'Administrative records from 3 years spanning intervention', 'description': 'Duration of employment in days, from employment records'}, {'measure': 'Job performance', 'timeFrame': 'Administrative records from 3 years spanning intervention', 'description': 'Numerical performance rating from annual review, from employment records'}, {'measure': 'Health care spending (i.e. dollars spent)', 'timeFrame': 'Administrative records from 3 years spanning intervention', 'description': 'Dollars spent on health care and prescription drugs for employees covered by employer-sponsored insurance, decomposed into spending on inpatient, outpatient, emergency department, and prescription drugs, from claims records'}, {'measure': 'Health care utilization (i.e. number of doctor visits, hospitalizations, or medications)', 'timeFrame': 'Administrative records from 3 years spanning intervention', 'description': 'Health care encounters and prescription drugs for employees covered by employer-sponsored insurance, decomposed into inpatient, outpatient, emergency department, and prescription drugs, from claims records'}, {'measure': 'Nutrition management', 'timeFrame': 'Primary data collected at 18 months and 30 months after initiation of intervention', 'description': 'Affirmative engagement in active efforts to improve nutrition, as indicated in responses to survey questions'}, {'measure': 'Stress management', 'timeFrame': 'Primary data collected at 18 months and 30 months after initiation of intervention', 'description': 'Unmanaged stress and stress at work, as indicated in responses to survey questions'}, {'measure': 'Screenings and exams', 'timeFrame': 'Primary data collected at 18 months and 30 months after initiation of intervention', 'description': 'Percent of recommended tests received, as indicated in responses to survey questions'}, {'measure': 'Tobacco use', 'timeFrame': 'Primary data collected at 18 months and 30 months after initiation of intervention', 'description': 'Smoking, as indicated in responses to survey questions'}, {'measure': 'Health and wellbeing', 'timeFrame': 'Primary data collected at 18 months and 30 months after initiation of intervention', 'description': 'Short form 8 (SF-8) physical and mental summary scores, as indicated in responses to survey questions. Each question of the SF-8 uses a 5- or 6-point Likert scale. Its standardized scoring system combines responses into a score that can be interpreted as a continuous variable (analogous to a 0-100 scale), with higher scores denoting better self-reported health.'}, {'measure': 'Blood glucose', 'timeFrame': 'Primary data collected at 18 months and 30 months after initiation of intervention', 'description': 'Blood glucose, measured'}, {'measure': 'Cholesterol', 'timeFrame': 'Primary data collected at 18 months and 30 months after initiation of intervention', 'description': 'Total cholesterol and high-density lipoprotein (HDL), measured'}], 'primaryOutcomes': [{'measure': 'Physical activity', 'timeFrame': 'Primary data collected at 18 months and 30 months after initiation of intervention', 'description': 'Regular exercise, number of hours sitting per day, and actively managing weight, as indicated in responses to survey questions'}, {'measure': 'Obesity', 'timeFrame': 'Primary data collected at 18 months and 30 months after initiation of intervention', 'description': 'Body Mass Index\\>=30, calculated from measured height and weight'}, {'measure': 'Absenteeism', 'timeFrame': 'Administrative records from 3 years spanning intervention', 'description': 'Number of sick or personal days as a share of total days employed, from employment records'}, {'measure': 'Health care spending', 'timeFrame': 'Administrative records from 3 years spanning intervention', 'description': 'Dollars spent on health care for employees covered by employer-sponsored insurance, from claims records'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Wellness', 'Prevention'], 'conditions': ['Health Behavior', 'Disease, Chronic']}, 'referencesModule': {'references': [{'pmid': '30990549', 'type': 'DERIVED', 'citation': 'Song Z, Baicker K. Effect of a Workplace Wellness Program on Employee Health and Economic Outcomes: A Randomized Clinical Trial. JAMA. 2019 Apr 16;321(15):1491-1501. doi: 10.1001/jama.2019.3307.'}]}, 'descriptionModule': {'briefSummary': "There is great public and private interest in the use of workplace wellness programs to reduce health care spending, improve health outcomes, and enhance productivity for employees. However, there is little rigorous evidence on the effects of wellness programs. This study partners with a large multi-state U.S. employer (BJ's Wholesale Club) and an experienced wellness vendor (Wellness Workdays) to evaluate a multi-prong workplace wellness program, including components such as nutrition counseling, fitness challenges, and stress management workshops. The wellness program will be delivered by a team of experts including Registered Dieticians, and will include financial rewards for participation. The program will be available to employees in initially 20 of BJ's 200 worksites, and later expanded to 25 worksites. These worksites have been randomly selected, allowing a randomized controlled trial evaluation of the effects of the wellness program. Data will be collected on a wide array of outcomes from multiple sources, including on-site biometric screenings and surveys, employment records, and health insurance claims for employees at both treatment and control worksites."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Employed in one of BJ's clubs during the period of the intervention\n\nExclusion Criteria:\n\n* Not employed in one of BJ's clubs during the period of the intervention"}, 'identificationModule': {'nctId': 'NCT03167658', 'briefTitle': 'The Impact of Employee Wellness Programs', 'organization': {'class': 'OTHER', 'fullName': 'Harvard School of Public Health (HSPH)'}, 'officialTitle': 'The Impact of Employee Wellness Programs', 'orgStudyIdInfo': {'id': 'Wellness 14-3141'}, 'secondaryIdInfos': [{'id': 'R01AG050329', 'link': 'https://reporter.nih.gov/quickSearch/R01AG050329', 'type': 'NIH'}, {'id': 'P30AG012810', 'link': 'https://reporter.nih.gov/quickSearch/P30AG012810', 'type': 'NIH'}, {'id': '72611', 'type': 'OTHER_GRANT', 'domain': 'Robert Wood Johnson Foundation'}, {'id': 'AEARCTR-0000586', 'type': 'REGISTRY', 'domain': 'American Economic Association Trial Registry'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': "Employees at treatment worksites will be given access to workplace wellness programming. Participation by employees will be voluntary, but all employees at treatment sites will be considered as part of the treatment group. Employees will also be invited to complete on-site biometric assessments and questionnaires. Data from secondary data sources (including employment records and health insurance claims) will be collected for employees at all BJ's worksites.", 'interventionNames': ['Behavioral: Workplace wellness program']}, {'type': 'NO_INTERVENTION', 'label': 'Primary Control', 'description': "Employees at primary control worksites will be invited to complete on-site biometric assessments and questionnaires, but will not have access to the workplace wellness programming. Data from secondary data sources (including employment records and health insurance claims) will be collected for employees at all BJ's worksites."}, {'type': 'NO_INTERVENTION', 'label': 'Secondary Control', 'description': "Employees at secondary control worksites will not participate in in-person screenings or questionnaires, and will not have access to workplace wellness programming. Data from secondary data sources (including employment records and health insurance claims) will be collected for employees at all BJ's worksites."}], 'interventions': [{'name': 'Workplace wellness program', 'type': 'BEHAVIORAL', 'description': 'Multi-prong workplace wellness program, with components such as nutrition counseling, fitness challenges, and stress management workshops, including supports and incentives.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Zirui Song, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harvard Medical School (HMS and HSDM)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harvard School of Public Health (HSPH)', 'class': 'OTHER'}, 'collaborators': [{'name': 'Robert Wood Johnson Foundation', 'class': 'OTHER'}, {'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}, {'name': 'Abdul Latif Jameel Poverty Action Lab', 'class': 'OTHER'}, {'name': 'University of Chicago', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Health Care Policy and Medicine', 'investigatorFullName': 'Zirui Song', 'investigatorAffiliation': 'Harvard Medical School (HMS and HSDM)'}}}}