- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00233259
Lifestyle Modification Program to Reduce Risk of Coronary Heart Disease in Latina Women With Diabetes
CHD Lifestyle Modification for Latinas With Diabetes
Study Overview
Status
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Colorado
-
Denver, Colorado, United States, 80237
- Institute for Health Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
Control group
|
Usual Diabetes Care Control group
|
Active Comparator: 1
Multiple risk factor intervention, that will include diet, physical activity, stress management, social support, and smoking cessation components
|
Mediterranean dietary program
Physical activity program
Stress management program
Social support
Smoking cessation program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adherence to the Mediterranean Diet, physical activity, stress management, and smoking cessation protocols
Time Frame: Measured at baseline, 6, 12, and 24 months
|
Measured at baseline, 6, 12, and 24 months
|
Hemoglobin A1c
Time Frame: Measured at baseline, 6, 12, and 24 months
|
Measured at baseline, 6, 12, and 24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Social support
Time Frame: Measured at baseline, 6, 12, and 24 months
|
Measured at baseline, 6, 12, and 24 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Deborah J. Toobert, PhD, Oregon Research Institute
Publications and helpful links
General Publications
- Toobert DJ, Strycker LA, King DK, Barrera M Jr, Osuna D, Glasgow RE. Long-term outcomes from a multiple-risk-factor diabetes trial for Latinas: inverted exclamation markViva Bien! Transl Behav Med. 2011 Sep;1(3):416-426. doi: 10.1007/s13142-010-0011-1.
- Toobert DJ, Strycker LA, Glasgow RE, Osuna D, Doty AT, Barrera M, Geno CR, Ritzwoller DP. Viva bien!: Overcoming recruitment challenges in a multiple-risk-factor diabetes trial. Am J Health Behav. 2010 Jul-Aug;34(4):432-41. doi: 10.5993/ajhb.34.4.5.
- Osuna D, Barrera M Jr, Strycker LA, Toobert DJ, Glasgow RE, Geno CR, Almeida F, Perdomo M, King D, Doty AT. Methods for the cultural adaptation of a diabetes lifestyle intervention for Latinas: an illustrative project. Health Promot Pract. 2011 May;12(3):341-8. doi: 10.1177/1524839909343279. Epub 2009 Oct 20.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 327
- R01HL076151 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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