Lifestyle Modification Program to Reduce Risk of Coronary Heart Disease in Latina Women With Diabetes
Condition: Cardiovascular Diseases; Heart Diseases; Diabetes Mellitus, Type 2
MeSH terms: Cardiovascular Diseases; Heart Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Mediterranean Diet; Physical Activity; Stress Management; Social Support; Smoking Cessation; Control group
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Other
Intervention description(s): Mediterranean dietary program; Physical activity program; Stress management program; Social support; Smoking cessation program; Usual Diabetes Care Control group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention