Ignite Creation Date:
2025-12-24 @ 11:46 AM
Ignite Modification Date:
2025-12-28 @ 2:43 PM
Study NCT ID:
NCT00708461
Status:
COMPLETED
Last Update Posted:
2019-11-01
First Post:
2008-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Environmental Intervention for Weight Gain Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'linde074@umn.edu', 'phone': '612-624-0065', 'title': 'Jennifer A. Linde, Ph.D.', 'organization': 'University of Minnesota'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The recruitment goal of 6 sites represents only 3% of those initially contacted for participation, or 16% of eligible and interested sites. The design limits power due to the small sample size at the group level.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were tracked for the duration of the study (2 years at each site).', 'eventGroups': [{'id': 'EG000', 'title': 'Worksite Environmental Intervention', 'description': 'Changes to healthy food availability, physical activity opportunities and promotion, body weight scale access, and media enhancements to target weight gain prevention', 'otherNumAtRisk': 752, 'otherNumAffected': 0, 'seriousNumAtRisk': 752, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'No-contact Control', 'description': 'No-treatment control condition. Worksites were offered program materials upon completion of programs at intervention sites.', 'otherNumAtRisk': 995, 'otherNumAffected': 0, 'seriousNumAtRisk': 995, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Body Mass Index (BMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '580', 'groupId': 'OG000'}, {'value': '742', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Worksite Environmental Intervention', 'description': 'Changes to healthy food availability, physical activity opportunities and promotion, body weight scale access, and media enhancements to target weight gain prevention'}, {'id': 'OG001', 'title': 'No-contact Control', 'description': 'No-treatment control condition. Worksites were offered program materials upon completion of programs at intervention sites.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.315', 'spread': '0.08959', 'groupId': 'OG000'}, {'value': '0.190', 'spread': '0.07987', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.36', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.125', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.46', 'pValueComment': 'Adjusted for age, educational attainment, race/ethnicity, and smoking status as individual, fixed-effect covariates. 95% confidence intervals and p-values derived from t-statistics with 4 degrees of freedom, reflecting the group-randomized design.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1202', 'groupDescription': 'The null hypothesis was no effect of the environmental intervention. The following power assumptions were made:\n\n* Intraclass correlation (ICC) of 0.016, estimated from an earlier study\n* Variance of 118 kg, estimated from an earlier study\n* Cohort N=400\n* 15% attrition (by turnover) Using the external control and a worksite correlation of 0.2 gives a detectable difference of about 1.5 kg or 3 lb, or an effect size of 0.14. The effect size using internal control is 0.20.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Adjusted for age, educational attainment, race/ethnicity, and smoking status as individual, fixed-effect covariates.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 24 months', 'description': 'Assessed in kilograms per meter squared.', 'unitOfMeasure': 'kilograms per meter squared', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with complete data at baseline and two years, and those who were not pregnant at either time, were retained for analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Worksite Environmental Intervention', 'description': 'Changes to healthy food availability, physical activity opportunities and promotion, body weight scale access, and media enhancements to target weight gain prevention'}, {'id': 'FG001', 'title': 'No-contact Control', 'description': 'No-treatment control condition. Worksites were offered program materials upon completion of programs at intervention sites.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '752'}, {'groupId': 'FG001', 'numSubjects': '995'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '611'}, {'groupId': 'FG001', 'numSubjects': '795'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '141'}, {'groupId': 'FG001', 'numSubjects': '200'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'left workforce', 'reasons': [{'groupId': 'FG000', 'numSubjects': '115'}, {'groupId': 'FG001', 'numSubjects': '180'}]}]}], 'recruitmentDetails': 'Participants were recruited at worksites between January 2006 and April 2007. Human resources departments provided worksite contact information for all eligible employees; these email addresses and phone numbers were used for recruitment contact purposes.', 'preAssignmentDetails': 'A company-wide email was sent to eligible employees at all sites, describing the study and the partnership with the University. Employees were notified that a study staff member would contact them about the project within the next two weeks and were given the option to call study staff in advance to opt out or to enroll in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'BG000'}, {'value': '995', 'groupId': 'BG001'}, {'value': '1747', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Worksite Environmental Intervention', 'description': 'Changes to healthy food availability, physical activity opportunities and promotion, body weight scale access, and media enhancements to target weight gain prevention'}, {'id': 'BG001', 'title': 'No-contact Control', 'description': 'No-treatment control condition. Worksites were offered program materials upon completion of programs at intervention sites.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '729', 'groupId': 'BG000'}, {'value': '954', 'groupId': 'BG001'}, {'value': '1683', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.7', 'spread': '10.8', 'groupId': 'BG000'}, {'value': '43.1', 'spread': '10.6', 'groupId': 'BG001'}, {'value': '42.9', 'spread': '10.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '478', 'groupId': 'BG000'}, {'value': '608', 'groupId': 'BG001'}, {'value': '1086', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '274', 'groupId': 'BG000'}, {'value': '387', 'groupId': 'BG001'}, {'value': '661', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '752', 'groupId': 'BG000'}, {'value': '995', 'groupId': 'BG001'}, {'value': '1747', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1747}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-30', 'studyFirstSubmitDate': '2008-06-27', 'resultsFirstSubmitDate': '2011-12-13', 'studyFirstSubmitQcDate': '2008-06-27', 'lastUpdatePostDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-06-17', 'studyFirstPostDateStruct': {'date': '2008-07-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Body Mass Index (BMI)', 'timeFrame': 'Baseline to 24 months', 'description': 'Assessed in kilograms per meter squared.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['obesity', 'obesity prevention', 'worksite', 'environment', 'intervention'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '23108493', 'type': 'RESULT', 'citation': 'VanWormer JJ, Linde JA, Harnack LJ, Stovitz SD, Jeffery RW. Weight change and workplace absenteeism in the HealthWorks study. Obes Facts. 2012;5(5):745-52. doi: 10.1159/000345119. Epub 2012 Oct 24.'}, {'pmid': '22340088', 'type': 'RESULT', 'citation': 'Linde JA, Nygaard KE, MacLehose RF, Mitchell NR, Harnack LJ, Cousins JM, Graham DJ, Jeffery RW. HealthWorks: results of a multi-component group-randomized worksite environmental intervention trial for weight gain prevention. Int J Behav Nutr Phys Act. 2012 Feb 16;9:14. doi: 10.1186/1479-5868-9-14.'}, {'pmid': '21952267', 'type': 'RESULT', 'citation': 'VanWormer JJ, Linde JA, Harnack LJ, Stovitz SD, Jeffery RW. Is baseline physical activity a determinant of participation in worksite walking clubs? Data from the HealthWorks Trial. J Phys Act Health. 2012 Aug;9(6):849-56. doi: 10.1123/jpah.9.6.849. Epub 2011 Jul 29.'}, {'pmid': '21732212', 'type': 'RESULT', 'citation': 'VanWormer JJ, Linde JA, Harnack LJ, Stovitz SD, Jeffery RW. Self-weighing frequency is associated with weight gain prevention over 2 years among working adults. Int J Behav Med. 2012 Sep;19(3):351-8. doi: 10.1007/s12529-011-9178-1.'}, {'pmid': '23979097', 'type': 'DERIVED', 'citation': 'Graham DJ, Linde JA, Cousins JM, Jeffery RW. Environmental modifications and 2-year measured and self-reported stair-use: a worksite randomized trial. J Prim Prev. 2013 Dec;34(6):413-22. doi: 10.1007/s10935-013-0323-2.'}], 'seeAlsoLinks': [{'url': 'http://www.ahc.umn.edu/opc/research/OPC_Currently_Funded/home.html', 'label': 'HealthWorks is a study housed in the University of Minnesota Obesity Prevention Center.'}]}, 'descriptionModule': {'briefSummary': 'The primary aim of this research is to evaluate the efficacy of a multicomponent worksite-based, environmental intervention in reducing weight increase and obesity over time in working adults.', 'detailedDescription': 'This study is a randomized trial designed to evaluate the effectiveness of a multi-component worksite intervention with strong environmental components to prevent weight gain. Six worksites will be randomized to either an intervention or a no-treatment control group. The intervention will be comprised of 1) changing the availability, portion sizes, and prices of foods and beverages sold to employees in their worksites in ways that encourage healthier food choices; 2) increasing the availability of physical activity opportunities at the worksite by implementing walking programs and increasing stairwell access and attractiveness; 3) placing scales in the work environment to encourage body weight monitoring and to enable workers to set goals for their weight; and 4) to provide educational materials to all employees to make them aware of the environmental intervention and of behavioral practices likely to be effective in preventing weight gain. The intervention will be implemented for a 2-year period in each intervention site. Effectiveness will be evaluated by assessing body weight, eating behavior and physical activity in a cohort of employees in both control and intervention sites at baseline and again 2 years later. Weight trends in these populations will also be compared to data from national and state-level annual surveys of weight in representative population samples. Data will be collected on the effects of specific intervention components via aggregate measures of food choice and physical activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 or older\n* generally in good health\n* part- or full-time employee in one of the participating worksites\n\nExclusion Criteria:\n\n* work on site \\<50% of the time\n* work second or third shift'}, 'identificationModule': {'nctId': 'NCT00708461', 'acronym': 'HealthWorks', 'briefTitle': 'Environmental Intervention for Weight Gain Prevention', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Environmental Intervention for Weight Gain Prevention', 'orgStudyIdInfo': {'id': '0408S62609'}, 'secondaryIdInfos': [{'id': '5R01DK067362', 'link': 'https://reporter.nih.gov/quickSearch/5R01DK067362', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Worksite Environmental Intervention', 'description': 'Changes to healthy food availability, physical activity opportunities and promotion, body weight scale access, and media enhancements to target weight gain prevention', 'interventionNames': ['Behavioral: weight gain prevention']}, {'type': 'NO_INTERVENTION', 'label': 'No-contact control', 'description': 'No-treatment control condition. Worksites were offered program materials upon completion of programs at intervention sites.'}], 'interventions': [{'name': 'weight gain prevention', 'type': 'BEHAVIORAL', 'otherNames': ['worksite intervention', 'obesity prevention'], 'description': '1. Changes in the food environment that increase the availability of healthy foods and beverages, reduce food and beverage portion sizes, reduce prices on healthy food items, and increase prices on less healthy food items.\n2. Changes in the activity environment that increase cues and incentives for walking at work and at home, using stairs, and to increase exposure of employees to information about active recreational opportunities at work and at home.\n3. Changes to the environment to increase cues and incentives for regular weight monitoring by providing scales at convenient locations.\n4. Changes in the informational environment that increase frequency of exposure of the employee population to accurate information about healthy food and activity choices.', 'armGroupLabels': ['Worksite Environmental Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55454', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Robert W Jeffery, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota, Division of Epidemiology and Community Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}