Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT01299051
Status:
COMPLETED
Last Update Posted:
2016-03-08
First Post:
2011-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Steps to Health: Targeting Obesity in the Health Care Workplace
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 550}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-07', 'studyFirstSubmitDate': '2011-02-03', 'studyFirstSubmitQcDate': '2011-02-16', 'lastUpdatePostDateStruct': {'date': '2016-03-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight loss', 'timeFrame': '~1-2 years post baseline', 'description': 'Determine whether employees participating in STH+ will lose significantly more body mass than participants in STH.'}], 'secondaryOutcomes': [{'measure': 'Improvement in level of physical activity', 'timeFrame': '~1-2 years post baseline.', 'description': 'Determine whether employees participating in STH+ will experience greater improvements level or amount of physical activity than employees in STH.'}, {'measure': 'Relative impact of the different programs', 'timeFrame': '~1-2 years post baseline', 'description': 'Determine the relative impact of STH+ and STH on 1) reduction in workplace injuries and associated costs, 2) health care utilization and health claim reimbursements, and 3) absenteeism and presenteeism.'}, {'measure': 'Relative cost of different programs', 'timeFrame': '~1-3 years post baseline', 'description': 'Determine the overall relative impact of STH+ and STH on net program costs.'}, {'measure': 'Improvement in nutrition', 'timeFrame': '~1-2 years post baseline', 'description': 'Determine whether employees participating in STH+ will experience greater improvements in diet, as measured by amount of calories consumed from fat and amount of fruits and vegetables consumed than employees in STH.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Weight Management', 'Employee Health'], 'conditions': ['Overweight', 'Obese']}, 'referencesModule': {'references': [{'pmid': '23648394', 'type': 'BACKGROUND', 'citation': 'Ostbye T, Stroo M, Brouwer RJ, Peterson BL, Eisenstein EL, Fuemmeler BF, Joyner J, Gulley L, Dement JM. The steps to health employee weight management randomized control trial: rationale, design and baseline characteristics. Contemp Clin Trials. 2013 Jul;35(2):68-76. doi: 10.1016/j.cct.2013.04.007. Epub 2013 May 3.'}, {'pmid': '25654520', 'type': 'RESULT', 'citation': 'Ostbye T, Stroo M, Brouwer RJ, Peterson BL, Eisenstein EL, Fuemmeler BF, Joyner J, Gulley L, Dement JM. Steps to Health employee weight management randomized control trial: short-term follow-up results. J Occup Environ Med. 2015 Feb;57(2):188-95. doi: 10.1097/JOM.0000000000000335.'}, {'pmid': '26849260', 'type': 'RESULT', 'citation': 'Ostbye T, Stroo M, Eisenstein EL, Dement JM. The Effects of Two Workplace Weight Management Programs and Weight Loss on Health Care Utilization and Costs. J Occup Environ Med. 2016 Feb;58(2):162-9. doi: 10.1097/JOM.0000000000000586.'}]}, 'descriptionModule': {'briefSummary': "The proposal of this study is to compare the effectiveness of two worksite weight management programs at Duke: Steps to Health (STH) ('usual standard of care') and the more extensive Steps to Health Plus! (STH+). We have added an additional follow-up, by invitation only, for participants in the study who agreed to be contacted for future research.", 'detailedDescription': 'Steps to Health and Steps to Health Plus! aim to help Duke employees achieve weight loss and maintain healthy weights. We will be following participants in these programs over a two year period. These two groups will be compared with an observational comparison group of employees who meet eligibility criteria but do not take part in the randomized controlled trial. We will assess whether the two programs decrease obesity-related injuries in the workplace and estimate the net costs of the two programs relative to their effectiveness more broadly.\n\nIn the additional follow-up, we will be assessing factors that may be related to program success. This will include a survey as well as some focus group data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Completion of a Health Risk Assessment\n* BMI ≥ 30\n* Able to read and understand study materials which are presented in English\n* No plans to leave Duke in the next year\n* Enrolled in one of the Duke health plans\n* Not currently pregnant\n\nExclusion Criteria:\n\n* Enrolled in the other available individual intervention programs (hypertension, cholesterol or pre-diabetes)\n* Enrolling in one of the LFL weight management programs in order to qualify for bariatric surgery'}, 'identificationModule': {'nctId': 'NCT01299051', 'briefTitle': 'Steps to Health: Targeting Obesity in the Health Care Workplace', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Steps to Health: Targeting Obesity in the Health Care Workplace', 'orgStudyIdInfo': {'id': 'Pro00010727'}, 'secondaryIdInfos': [{'id': 'R01HD06578', 'type': 'OTHER_GRANT', 'domain': 'National Institute of Occupational Safety and Health'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Steps to Health', 'description': 'Steps to Health worksite weight management program at Duke.', 'interventionNames': ['Behavioral: Steps to Health']}, {'type': 'EXPERIMENTAL', 'label': 'Steps to Health Plus!', 'description': 'Steps to Health Plus! worksite weight management program at Duke. Also known as Pathways to Change.', 'interventionNames': ['Behavioral: Steps to Health Plus!']}, {'type': 'NO_INTERVENTION', 'label': 'Observational Comparison', 'description': 'Observational comparison group consisting of employees who are eligible for the study but do not take part will also be used in analyses (approximately 1500 subjects).'}], 'interventions': [{'name': 'Steps to Health', 'type': 'BEHAVIORAL', 'otherNames': ['STH'], 'description': 'Steps to Health (STH): The STH curriculum is a 12-month educational program targeting obese employees for healthy lifestyle changes for weight loss. The program includes:\n\n* Face-to-face visit with counselor during Month 1 to set specific health goals.\n* Telephone counseling at 6 and 12 months, coupled with biometric feedback sessions.\n* Monthly generic health education materials sent via e-mail.\n* Incentives (up to 1,000 STH dollars \\[$100\\]) to take part in the program assessments.', 'armGroupLabels': ['Steps to Health']}, {'name': 'Steps to Health Plus!', 'type': 'BEHAVIORAL', 'otherNames': ['STH+, PTC'], 'description': 'The STH+ intervention is an intensive 12-month behavioral intervention targeting obese employees. It is stage-based and works with the participant at his/her level of readiness to change using counseling based on motivational interviewing. STH+ includes:\n\n* Face-to-face visit with counselor at Month 1\n* Meeting with exercise physiologist in Month 2\n* Monthly counseling sessions (in-person in Months 3, 6, 9 and 12, others via telephone)\n* Meeting with exercise physiologist during Month 5\n* Quarterly biometric feedback (Months 3, 6, 9, and 12)\n* Incentives (up to 1,000 STH dollars \\[$100\\]) to take part in the program assessments.', 'armGroupLabels': ['Steps to Health Plus!']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Dept. of Community and Family Medicine', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Truls Ostbye, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}