Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT00717158
Status:
COMPLETED
Last Update Posted:
2008-07-16
First Post:
2008-07-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lifestyle Intervention's Impact on Health Care Costs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015438', 'term': 'Health Behavior'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 147}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-08', 'completionDateStruct': {'date': '2003-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-07-14', 'studyFirstSubmitDate': '2008-07-14', 'studyFirstSubmitQcDate': '2008-07-14', 'lastUpdatePostDateStruct': {'date': '2008-07-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health Care utilization and costs using claims data', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'Weight change', 'timeFrame': 'one year'}, {'measure': 'Change in hemoglobin A1c', 'timeFrame': 'One Year'}, {'measure': 'Work days lost', 'timeFrame': 'One year'}, {'measure': 'Disability Days', 'timeFrame': 'One year'}, {'measure': 'Change in quality of life', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Health Behavior', 'Lifestyle', 'health care costs', 'quality of life'], 'conditions': ['Diabetes Mellitus, Type 2', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '15220230', 'type': 'RESULT', 'citation': 'Wolf AM, Conaway MR, Crowther JQ, Hazen KY, L Nadler J, Oneida B, Bovbjerg VE; Improving Control with Activity and Nutrition (ICAN) Study. Translating lifestyle intervention to practice in obese patients with type 2 diabetes: Improving Control with Activity and Nutrition (ICAN) study. Diabetes Care. 2004 Jul;27(7):1570-6. doi: 10.2337/diacare.27.7.1570.'}, {'pmid': '17659904', 'type': 'RESULT', 'citation': 'Wolf AM, Siadaty M, Yaeger B, Conaway MR, Crowther JQ, Nadler JL, Bovbjerg VE. Effects of lifestyle intervention on health care costs: Improving Control with Activity and Nutrition (ICAN). J Am Diet Assoc. 2007 Aug;107(8):1365-73. doi: 10.1016/j.jada.2007.05.015.'}]}, 'descriptionModule': {'briefSummary': 'The ICAN Pilot project aims to evaluate the differences in economic, clinical and quality of life outcomes of a nutrition intervention involving lifestyle case management and medical nutrition therapy by a registered dietitian compared to usual medical care in obese persons with type 2 diabetes. The intervention is aimed at moderate weight loss (\\> 5-10%), improvement in diet quality and an increase in physical activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\> 30 kg/m2, calculated from measured weight and height.\n* Type 2 diabetics on medication for their diabetes.\n* Age 20 -60 years of age.\n* Have phone.\n* Fluency in reading, writing and comprehension of English\n* Have Qualchoice as their primary health insurer.\n\nExclusion Criteria:\n\n* Depression, BDI score \\> 20\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT00717158', 'acronym': 'ICAN', 'briefTitle': "Lifestyle Intervention's Impact on Health Care Costs", 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Evaluating Healthcare Utilization, Costs and Health-Related Outcomes of a Medical Nutrition Therapy Intervention on Obese Patients With Type 2 Diabetes - A Pilot Study', 'orgStudyIdInfo': {'id': '8742'}, 'secondaryIdInfos': [{'id': 'Am Dietetic Assoc 9336'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'I', 'description': 'Usual medical care. They received written healthy lifestyle information', 'interventionNames': ['Behavioral: Usual medical care']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Intervention participants were assigned to one registered dietitian who they met with over a one year period for 6 session (four hours) of individual care, 6- one-hour group classes, and had monthly email contact for follow up and checking in', 'interventionNames': ['Behavioral: Lifestyle Case management']}], 'interventions': [{'name': 'Usual medical care', 'type': 'BEHAVIORAL', 'armGroupLabels': ['I']}, {'name': 'Lifestyle Case management', 'type': 'BEHAVIORAL', 'description': 'Intervention participants were assigned to one registered dietitian who they met with over a one year period for 6 session (four hours) of individual care, 6- one-hour group classes, and had monthly email contact for follow up and checking in', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia School of Medicine', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'Anne M Wolf, MS, RD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Anne Wolf, Principal Investigator', 'oldOrganization': 'University of Virginia School of Medicine'}}}}