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Lifestyle Modification Program to Reduce Risk of Coronary Heart Disease in Latina Women With Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00233259
Recruitment Status : Completed
First Posted : October 5, 2005
Last Update Posted : October 25, 2011
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Oregon Research Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Heart Diseases Diabetes Mellitus, Type 2 Behavioral: Mediterranean Diet Behavioral: Physical Activity Behavioral: Stress Management Behavioral: Social Support Behavioral: Smoking Cessation Other: Control group Not Applicable

Detailed Description:


Age-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.


Hispanic 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 273 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: CHD Lifestyle Modification for Latinas With Diabetes
Study Start Date : March 2006
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
Multiple risk factor intervention, that will include diet, physical activity, stress management, social support, and smoking cessation components
Behavioral: Mediterranean Diet
Mediterranean dietary program

Behavioral: Physical Activity
Physical activity program

Behavioral: Stress Management
Stress management program

Behavioral: Social Support
Social support

Behavioral: Smoking Cessation
Smoking cessation program

Placebo Comparator: 2
Control group
Other: Control group
Usual Diabetes Care Control group

Primary Outcome Measures :
  1. Adherence to the Mediterranean Diet, physical activity, stress management, and smoking cessation protocols [ Time Frame: Measured at baseline, 6, 12, and 24 months ]
  2. Hemoglobin A1c [ Time Frame: Measured at baseline, 6, 12, and 24 months ]

Secondary Outcome Measures :
  1. Social support [ Time Frame: Measured at baseline, 6, 12, and 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Type 2 diabetes
  • Postmenopausal
  • Latina

Exclusion criteria:

  • Cognitive impairment or inability to comprehend program
  • Has other life-threatening illnesses
  • Planning to move from the area during the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00233259

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United States, Colorado
Institute for Health Research
Denver, Colorado, United States, 80237
Sponsors and Collaborators
Oregon Research Institute
National Heart, Lung, and Blood Institute (NHLBI)
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Study Chair: Deborah J. Toobert, PhD Oregon Research Institute
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Oregon Research Institute Identifier: NCT00233259    
Other Study ID Numbers: 327
R01HL076151 ( U.S. NIH Grant/Contract )
First Posted: October 5, 2005    Key Record Dates
Last Update Posted: October 25, 2011
Last Verified: October 2011
Additional relevant MeSH terms:
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Cardiovascular Diseases
Heart Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases