Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-03-06 @ 5:29 PM
Study NCT ID:
NCT02850094
Status:
COMPLETED
Last Update Posted:
2025-11-24
First Post:
2016-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The BWH Wellness Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 292}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2016-07-27', 'studyFirstSubmitQcDate': '2016-07-27', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical Activity', 'timeFrame': '6 Months', 'description': 'Minutes of moderate to vigorous physical activity (greater than 100 steps/minute)'}], 'secondaryOutcomes': [{'measure': 'Individuals Meeting CDC Guidelines', 'timeFrame': '6 Months', 'description': 'Percentage of cohort that achieved 150 minutes of moderate PA per week'}, {'measure': 'Fitbit Adherence', 'timeFrame': '6 Months', 'description': 'Percentage of cohort that wore their Fitbit for four or more days per week for at least 20 out of 24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Physical activity', 'Exercise', 'Financial Incentives'], 'conditions': ['Physical Activity']}, 'referencesModule': {'references': [{'pmid': '30808208', 'type': 'DERIVED', 'citation': 'Meints SM, Yang HY, Collins JE, Katz JN, Losina E. Race Differences in Physical Activity Uptake Within a Workplace Wellness Program: A Comparison of Black and White Employees. Am J Health Promot. 2019 Jul;33(6):886-893. doi: 10.1177/0890117119833341. Epub 2019 Feb 26.'}, {'pmid': '29195494', 'type': 'DERIVED', 'citation': 'Losina E, Smith SR, Usiskin IM, Klara KM, Michl GL, Deshpande BR, Yang HY, Smith KC, Collins JE, Katz JN. Implementation of a workplace intervention using financial rewards to promote adherence to physical activity guidelines: a feasibility study. BMC Public Health. 2017 Dec 1;17(1):921. doi: 10.1186/s12889-017-4931-2.'}, {'pmid': '28872399', 'type': 'DERIVED', 'citation': 'Smith KC, Michl GL, Katz JN, Losina E. Meteorologic and Geographic Barriers to Physical Activity in a Workplace Wellness Program. J Phys Act Health. 2018 Feb 1;15(2):108-116. doi: 10.1123/jpah.2016-0731. Epub 2017 Nov 25.'}]}, 'descriptionModule': {'briefSummary': "The investigators propose a 24 week program to provide proof-of-principle evidence that financial incentives stimulate Brigham and Women's Hospital (BWH) employees to be more physically active.", 'detailedDescription': 'Participants wear a Fitbit Flex accelerometer for at least six months. During the first two weeks, they are paid simply for wearing the Fitbit. After that, they are regularly paid for either meeting CDC guidelines for moderate physical activity (PA) or increasing their PA by at least 10% from the preceding week. Moderate PA is defined as walking for at least 100 steps per minute for at least 10 minutes at a time. One minute of vigorous PA, over 175 steps/minute, counts as two minutes of moderate PA.\n\nIn addition to weekly bonuses, there are also bonuses for achieving all goals in 1 month, 3 month, and 6 month intervals. In cases where all three team members received a bonus, their bonuses are doubled. Individuals also fill out weekly questionnaires about their work attendance, as well as longer questionnaires at baseline, three months, and six months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Brigham and Women's Hospital employee\n* Reported less than 30 minutes of exercise per week\n* Use a computer daily at work or home\n* Willing to wear a pedometer, undergo health screening, and complete occasional questionnaires\n\nExclusion Criteria:\n\n* Occupation: Physician, nurse or other clinician\n* Self-reported pregnancy at baseline"}, 'identificationModule': {'nctId': 'NCT02850094', 'acronym': 'B-Well', 'briefTitle': 'The BWH Wellness Project', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': "The Brigham and Women's Hospital Wellness Project", 'orgStudyIdInfo': {'id': '2014P000970'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Financial Bonuses', 'description': "For two weeks following enrollment, subjects are monitored via their FitBit accelerometer to monitor their pre-intervention physical activity levels. For a twenty-four week period following the observational period, participants are eligible for financial bonuses based on their increased activity. Participants enroll as teams and are eligible for additional financial bonuses based on their team's performance.", 'interventionNames': ['Behavioral: Financial Bonuses']}], 'interventions': [{'name': 'Financial Bonuses', 'type': 'BEHAVIORAL', 'description': "Each participant is eligible to receive $10 per week for increasing their minutes of moderate to vigorous physical activity by 10% from the previous week, or for meeting CDC guidelines of 150 minutes/week. Participants who meet their target minutes of PA every week for one month, three months, or six months receive $15, $25, or $50 bonuses respectively. If all members of a team meet their individual PA goals, each participant's reward is doubled. In total, participants can earn up to $860 if they meet all their goals.", 'armGroupLabels': ['Financial Bonuses']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Orthopaedic Surgery', 'investigatorFullName': 'Elena Losina', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}