Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00233259
Status:
COMPLETED
Last Update Posted:
2011-10-25
First Post:
2005-10-03
Brief Title:
Lifestyle Modification Program to Reduce Risk of Coronary Heart Disease in Latina Women With Diabetes
Sponsor:
Oregon Research Institute
Organization:
Oregon Research Institute
Study Overview
Official Title:
CHD Lifestyle Modification for Latinas With Diabetes
Status:
COMPLETED
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 US 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 ie 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 eg 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 programs readiness to be put into practice and 5 measuring the robustness reach and cost-effectiveness of the program
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 US 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 ie 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 eg 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 programs readiness to be put into practice and 5 measuring the robustness reach and cost-effectiveness of the program
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL076151 | NIH | None | httpsreporternihgovquickSearchR01HL076151 |