Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:45 PM
Study NCT ID:
NCT03431051
Status:
UNKNOWN
Last Update Posted:
2022-08-12
First Post:
2018-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of Workplace Food and Beverage Choices on Health and Wellness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 648}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-10', 'studyFirstSubmitDate': '2018-01-29', 'studyFirstSubmitQcDate': '2018-02-09', 'lastUpdatePostDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abdominal adiposity', 'timeFrame': 'About one year.', 'description': 'Study participants at HBI campuses will show improvements (specifically, decreases) in indices of abdominal adiposity measured using waist circumference in centimeters.'}, {'measure': 'Abdominal adiposity', 'timeFrame': 'About one year.', 'description': 'Study participants at HBI campuses will show improvements (specifically, decreases) in indices of abdominal adiposity measured using sagittal abdominal diameter in centimeters.'}], 'secondaryOutcomes': [{'measure': 'Body Mass Index (BMI)', 'timeFrame': 'About one year.', 'description': 'Study participants at HBI campuses will show improvements (specifically, decreases) in body mass index \\[BMI\\] measured using height in centimeters and weight in kilograms to be calculated into BMI in kg/m\\^2.'}, {'measure': 'Sugar Sweetened Beverage Intake', 'timeFrame': 'About one year.', 'description': 'Study participants at HBI campuses will show improvements (specifically, decreases) in SSB intake measured by the BEVQ (beverage food frequency questionnaire).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthy Beverage Initiative, Sugar Sweetened Beverages'], 'conditions': ['Health and Wellness']}, 'descriptionModule': {'briefSummary': 'The study is designed to determine if instituting a Healthy Beverage Initiative (HBI) at hospitals influences health and wellness of employees over a 12 month period.', 'detailedDescription': 'To examine whether HBI is associated with decreased adiposity over a 12-month time period, in comparison to individuals identically assessed but not exposed to a HBI. Specifically, do those exposed to the HBI decrease in measures of adiposity, BMI, and sugar sweetened beverage (SSB) intake? Do they decrease more in those measures as compared to those not exposed to the HBI?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The participant speaks and reads English.\n* The participant consumes three or more sugar-sweetened beverages a week.\n* The participant expects to be able to participate for all 3 visits (baseline, 6 months, and 12 months).\n\nExclusion Criteria:\n\nThe participant is planning an extended leave of absence and/or family medical leave of absence over the next 12 months.'}, 'identificationModule': {'nctId': 'NCT03431051', 'briefTitle': 'The Impact of Workplace Food and Beverage Choices on Health and Wellness', 'organization': {'class': 'OTHER', 'fullName': 'California Pacific Medical Center Research Institute'}, 'officialTitle': 'The Impact of Workplace Food and Beverage Choices on Health and Wellness', 'orgStudyIdInfo': {'id': 'Healthy Beverage Initiative'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy Beverage Initiative', 'description': 'A Healthy Beverage Initiative and health education will be implemented at two hospital campuses.', 'interventionNames': ['Other: Healthy Beverage Initiative']}, {'type': 'NO_INTERVENTION', 'label': 'Control Arm', 'description': 'No change in beverages or education at two hospital campuses.'}], 'interventions': [{'name': 'Healthy Beverage Initiative', 'type': 'OTHER', 'description': 'A Healthy Beverage Initiative will be instituted at two hospital campuses.', 'armGroupLabels': ['Healthy Beverage Initiative']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'California Pacific Medical Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Greg Tranah, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sutter Health-California Pacific Medical Center Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'California Pacific Medical Center Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Laura and John Arnold Foundation', 'class': 'OTHER'}, {'name': 'University of California, San Francisco', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Clinical Research', 'investigatorFullName': 'Jamey Schmidt', 'investigatorAffiliation': 'California Pacific Medical Center Research Institute'}}}}