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

Study Overview
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Brief Summary
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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.

Detailed Description
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BACKGROUND: 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. DESIGN NARRATIVE: 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.

Official Title
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CHD Lifestyle Modification for Latinas With Diabetes

Conditions
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Cardiovascular Diseases, Heart Diseases, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Mediterranean Diet
* Behavioral: Physical Activity
* Behavioral: Stress Management
* Behavioral: Social Support
* Behavioral: Smoking Cessation
* Other: Control group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Multiple risk factor intervention, that will include diet, physical activity, stress management, social support, and smoking cessation components | Behavioral: Mediterranean Diet<br>* Mediterranean dietary program<br>Behavioral: Physical Activity<br>* Physical activity program<br>Behavioral: Stress Management<br>* Stress management program<br>Behavioral: Social Support<br>* Social support<br>Behavioral: Smoking Cessation<br>* Smoking cessation program<br>|
| Placebo Comparator: 2<br>Control group | Other: Control group<br>* Usual Diabetes Care Control group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to the Mediterranean Diet, physical activity, stress management, and smoking cessation protocols |  | Measured at baseline, 6, 12, and 24 months | 
| Hemoglobin A1c |  | Measured at baseline, 6, 12, and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social support |  | Measured at baseline, 6, 12, and 24 months |