Trial record 19 of 110 for:    (hispanic OR latina) AND (woman OR women OR female)

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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Oregon Research Institute
ClinicalTrials.gov Identifier:
NCT00233259
First received: October 3, 2005
Last updated: October 24, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Cardiovascular Diseases
Heart Diseases
Diabetes Mellitus, Type 2
Behavioral: Mediterranean Diet
Behavioral: Physical Activity
Behavioral: Stress Management
Behavioral: Social Support
Behavioral: Smoking Cessation
Other: Control group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: CHD Lifestyle Modification for Latinas With Diabetes

Resource links provided by NLM:


Further study details as provided by Oregon Research Institute:

Primary Outcome Measures:
  • Adherence to the Mediterranean Diet, physical activity, stress management, and smoking cessation protocols [ Time Frame: Measured at baseline, 6, 12, and 24 months ] [ Designated as safety issue: No ]
  • Hemoglobin A1c [ Time Frame: Measured at baseline, 6, 12, and 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Social support [ Time Frame: Measured at baseline, 6, 12, and 24 months ] [ Designated as safety issue: No ]

Enrollment: 273
Study Start Date: March 2006
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Multiple risk factor intervention, that will include diet, physical activity, stress management, social support, and smoking cessation components
Behavioral: Mediterranean Diet
Mediterranean dietary program
Behavioral: Physical Activity
Physical activity program
Behavioral: Stress Management
Stress management program
Behavioral: Social Support
Social support
Behavioral: Smoking Cessation
Smoking cessation program
Placebo Comparator: 2
Control group
Other: Control group
Usual Diabetes Care Control group

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.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00233259

Locations
United States, Colorado
Institute for Health Research
Denver, Colorado, United States, 80237
Sponsors and Collaborators
Oregon Research Institute
Investigators
Study Chair: Deborah J. Toobert, PhD Oregon Research Institute
  More Information

No publications provided by Oregon Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Oregon Research Institute
ClinicalTrials.gov Identifier: NCT00233259     History of Changes
Other Study ID Numbers: 327, R01HL076151, R01 HL76151
Study First Received: October 3, 2005
Last Updated: October 24, 2011
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Heart Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014