跳至主要内容
临床试验/NCT00233259
NCT00233259已完成不适用

CHD Lifestyle Modification for Latinas With Diabetes

Oregon Research Institute2 个研究点 分布在 1 个国家目标入组 273 人开始时间: 2006年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
273
试验地点
2
主要终点
Adherence to the Mediterranean Diet, physical activity, stress management, and smoking cessation protocols

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
30 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Type 2 diabetes
  • Postmenopausal
  • Exclusion criteria:
  • Cognitive impairment or inability to comprehend program
  • Has other life-threatening illnesses
  • Planning to move from the area during the study

排除标准

  • 未提供

结局指标

主要结局

Adherence to the Mediterranean Diet, physical activity, stress management, and smoking cessation protocols

时间窗: Measured at baseline, 6, 12, and 24 months

Hemoglobin A1c

时间窗: Measured at baseline, 6, 12, and 24 months

次要结局

  • Social support(Measured at baseline, 6, 12, and 24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验