Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2026-01-03 @ 10:23 PM
Study NCT ID:
NCT00233259
Status:
COMPLETED
Last Update Posted:
2011-10-25
First Post:
2005-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lifestyle Modification Program to Reduce Risk of Coronary Heart Disease in Latina Women With Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D038441', 'term': 'Diet, Mediterranean'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D000095500', 'term': 'Diet, Plant-Based'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 273}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-24', 'studyFirstSubmitDate': '2005-10-03', 'studyFirstSubmitQcDate': '2005-10-03', 'lastUpdatePostDateStruct': {'date': '2011-10-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence to the Mediterranean Diet, physical activity, stress management, and smoking cessation protocols', 'timeFrame': 'Measured at baseline, 6, 12, and 24 months'}, {'measure': 'Hemoglobin A1c', 'timeFrame': 'Measured at baseline, 6, 12, and 24 months'}], 'secondaryOutcomes': [{'measure': 'Social support', 'timeFrame': 'Measured at baseline, 6, 12, and 24 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cardiovascular Diseases', 'Heart Diseases', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '22022345', 'type': 'DERIVED', 'citation': 'Toobert DJ, Strycker LA, King DK, Barrera M Jr, Osuna D, Glasgow RE. Long-term outcomes from a multiple-risk-factor diabetes trial for Latinas: inverted exclamation markViva Bien! Transl Behav Med. 2011 Sep;1(3):416-426. doi: 10.1007/s13142-010-0011-1.'}, {'pmid': '20218755', 'type': 'DERIVED', 'citation': 'Toobert DJ, Strycker LA, Glasgow RE, Osuna D, Doty AT, Barrera M, Geno CR, Ritzwoller DP. Viva bien!: Overcoming recruitment challenges in a multiple-risk-factor diabetes trial. Am J Health Behav. 2010 Jul-Aug;34(4):432-41. doi: 10.5993/ajhb.34.4.5.'}, {'pmid': '19843703', 'type': 'DERIVED', 'citation': 'Osuna D, Barrera M Jr, Strycker LA, Toobert DJ, Glasgow RE, Geno CR, Almeida F, Perdomo M, King D, Doty AT. Methods for the cultural adaptation of a diabetes lifestyle intervention for Latinas: an illustrative project. Health Promot Pract. 2011 May;12(3):341-8. doi: 10.1177/1524839909343279. Epub 2009 Oct 20.'}]}, 'descriptionModule': {'briefSummary': 'The Viva Bien! trial will comprehensively evaluate a multiple risk factor intervention (diet, physical activity, stress management, social support, and smoking cessation) in a randomized effectiveness trial, which will be offered in English and Spanish to diabetic Latinas.', 'detailedDescription': "BACKGROUND:\n\nAge-adjusted mortality from coronary heart disease (CHD) has been increasing in women with diabetes. On the other hand, it has been decreasing in women without diabetes and in men with and without diabetes. CHD remains the leading cause of death among women in the United States. Risks of CHD and resulting death are significantly higher among postmenopausal women; these rates are two and a half times higher among women with diabetes versus women without diabetes. Diabetes is an independent risk factor for CHD in both Latina and Anglo women, but it appears to be a greater risk factor for U.S. born Latinas, as they have higher mortality from diabetes. Among Latinas, diabetes ranks as the third leading cause of death.\n\nDESIGN NARRATIVE:\n\nHispanic Americans, in particular postmenopausal Hispanic women, have an increased prevalence of type 2 diabetes, and a greater incidence of diabetes complications than non-Hispanic whites. The LLP will comprehensively evaluate a multiple risk factor intervention (diet, physical activity, stress management, social support, and smoking cessation) in a randomized effectiveness trial that will be offered in English and Spanish. The research team has shown that a similar theory-based comprehensive program, Mediterranean Lifestyle Program (MLP), is effective in improving behavioral, psychosocial, quality of life, and physiologic outcomes in postmenopausal Anglo women with type 2 diabetes. Though the results are promising, four important research issues must be addressed before such a program is ready to be put into practice. This study focuses on the following questions: 1) How should the structure and content of the MLP be modified to address the cultural characteristics of Latinas?; 2) Will the program succeed if offered within a large health plan that serves minority populations (i.e., the Kaiser Permanente site in Denver, CO)?; and 3) What are the economic implications of the LLP? The Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) evaluation framework will be used to assess how the program impacts certain dimensions that are important for carry over into clinical practice. Primary outcomes of this study will include change in behavioral measures. Secondary outcomes will include impacts on quality of life, physiologic measures, member satisfaction, and cost-effectiveness. The investigators will also study the relationship between cultural variables in this Hispanic population (e.g., family and social support; group cohesion; and acculturation) and program participation and outcomes. Substantial impacts of this study on public health include: 1) intervening with a high-risk, underserved population; 2) focusing on multiple critically important lifestyle behaviors known to reduce risk for CHD; 3) testing maintenance of behavioral changes; 4) employing methodology to estimate the program's readiness to be put into practice; and (5) measuring the robustness, reach, and cost-effectiveness of the program."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes\n* Postmenopausal\n* Latina\n\nExclusion criteria:\n\n* Cognitive impairment or inability to comprehend program\n* Has other life-threatening illnesses\n* Planning to move from the area during the study'}, 'identificationModule': {'nctId': 'NCT00233259', 'briefTitle': 'Lifestyle Modification Program to Reduce Risk of Coronary Heart Disease in Latina Women With Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Research Institute'}, 'officialTitle': 'CHD Lifestyle Modification for Latinas With Diabetes', 'orgStudyIdInfo': {'id': '327'}, 'secondaryIdInfos': [{'id': 'R01HL076151', 'link': 'https://reporter.nih.gov/quickSearch/R01HL076151', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Multiple risk factor intervention, that will include diet, physical activity, stress management, social support, and smoking cessation components', 'interventionNames': ['Behavioral: Mediterranean Diet', 'Behavioral: Physical Activity', 'Behavioral: Stress Management', 'Behavioral: Social Support', 'Behavioral: Smoking Cessation']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Control group', 'interventionNames': ['Other: Control group']}], 'interventions': [{'name': 'Mediterranean Diet', 'type': 'BEHAVIORAL', 'description': 'Mediterranean dietary program', 'armGroupLabels': ['1']}, {'name': 'Physical Activity', 'type': 'BEHAVIORAL', 'description': 'Physical activity program', 'armGroupLabels': ['1']}, {'name': 'Stress Management', 'type': 'BEHAVIORAL', 'description': 'Stress management program', 'armGroupLabels': ['1']}, {'name': 'Social Support', 'type': 'BEHAVIORAL', 'description': 'Social support', 'armGroupLabels': ['1']}, {'name': 'Smoking Cessation', 'type': 'BEHAVIORAL', 'description': 'Smoking cessation program', 'armGroupLabels': ['1']}, {'name': 'Control group', 'type': 'OTHER', 'description': 'Usual Diabetes Care Control group', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80237', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Institute for Health Research', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}], 'overallOfficials': [{'name': 'Deborah J. Toobert, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Oregon Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}