Only decades ago cardiovascular disease (CVD) was rare in American Indians, but today it has become the leading cause of death for this population, exceeding rates in the general population. To reduce cardiovascular risk, we propose a holistic behavioral and lifestyle intervention program that is community-responsive and culturally appropriate. This intervention program will primarily focus on behavioral modification in diet and physical activity, which will lead to improvement of CVD risk factors and consequently reduction of CVD. The specific aims are:

1. To design and implement a culturally appropriate behavioral intervention program for American Indian adults (aged 30-59 years), who have high risk of developing CVD, to form healthy habits in diet and physical activity.

2. To evaluate the effectiveness of the proposed behavioral intervention program using a two-arm randomized controlled design. Two hundred eligible American Indian men and women will be randomized into two groups: (1) "intervention" groups, which receives the proposed intervention program, and (2) "control" group, which receives conventional cardiovascular health information and advice only. Two sets of outcome measures will be used to compare the two groups. The primary outcome measures will be behavioral modification outcomes, including caloric intake, sodium intake and fruit and vegetable consumption for diet and pedometer measurements for physical activity. The secondary outcome measures are CVD risk factor measures, including weight (or BMI), total triglyceride, HDL-cholesterol, LDL-cholesterol, HbA1c, fasting glucose, blood pressure and urinary albumin/creatinine ratio.

3. If successful, disseminate the intervention program to other American Indian tribes and communities for implementation.

We hypothesize that participants in the intervention group will improve their caloric and sodium intake and increase fruit and vegetable consumption and physical activity when compared to the control group. The proposed intervention emphasizes achieving spiritual, mental, emotional and physical balance, which are elements of traditional American Indian wellness and vitality. The proposed intervention program is developed with much input from the Indian community and can be incorporated into tribal health programs. We believe it has a high probability of success and is highly sustainable in the community after the termination of this research study.

U01HL087354

2006-09-30

2012-06-30