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

Diabetes Mellitus, Type 2 Clinical Trial

Official title: CHD Lifestyle Modification for Latinas With Diabetes

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

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

• NCT number: NCT00233259
• Study type: Interventional
• Source: Oregon Research Institute
• Status: Completed
• Phase: N/A
• Start date: March 2006
• Completion date: August 2010