San Diego Partnership to Reduce Diabetes & Cardiovascular Disease in Latinos
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 587
- 试验地点
- 2
- 主要终点
- Change in Carotid Intimal Medial Thickness (CIMT) Measurement
研究概览
简要总结
The Latino population in the United States is increasing in size; is diverse in culture, backgrounds and countries of origin; is experiencing unique influences from social and behavioral acculturation to the U.S.; is reported nationally to have lower rates of heart disease; is reported to have increased prevalence of diabetes and asthma; and is generally poorer and less educated (NHLBI working Group, 2003). They represent an important target population for disparities research. In particular Latinos accessing care in Community Health Centers in the United States represent an ideal population for conducting disparities research because lack of access to care is minimized through various governmental health insurance support mechanisms. This study will build on existing relationships to conduct the proposed study, using expertise in epidemiologic, behavioral and genetic research in an effort to promote a coordinated, comprehensive, interdisciplinary and focused research effort to improve the care being delivered to indigent Latinos at-risk for and with CVD.
详细描述
This study will build on existing relationships to conduct the proposed study, using expertise in epidemiologic, behavioral and genetic research in an effort to promote a coordinated, comprehensive, interdisciplinary and focused research effort to improve the care being delivered to indigent Latinos at-risk for and with cardiovascular disease (CVD). This study consists of three study visits:
Study Visit 1 (Sv1):
During Sv1, which lasts about 2 hours, potential participants are recruited and the consenting process is completed with those who wish to take part in the study. Participants then have their blood pressure taken and blood draw takes place. After the blood draw participants will be given a snack before completing the battery of psychosocial, health history and risk factor questionnaires. Lastly, standing height, weight and bioelectric impedance (Tanita scale) will be measured to determine BMI/obesity as a risk factor. At the end of Sv1 participants will be given the GT3X actigraph to objectively monitor their physical activity. Participants will be asked to wear the activity monitor for seven days and asked to return the monitor at the Sv3 appointment.
Chart Audit:
A chart audit will be performed by a research assistant (RA) before Sv3 in order to confirm eligibility and confirm medical history. Information from the chart may also lead to exclude individuals with deteriorated health status. If such a condition is detected the investigators will consult with the primary care provider for confirmation and adjudication before notifying the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be of Hispanic/Latino ethnicity
- •be a registered patient at the SYHC, Inc.
- •be at least 40 years of age or older
- •have one or more modifiable CVD risk factors, which are defined here as: high LDL cholesterol (non-diabetic threshold = > 160 mg/dl, diabetic threshold = > 130 mg/dl), low HDL cholesterol (<40 mg/dl), Obesity (BMI > 30 kg/m2), Cigarette smoking (daily smoker), Diabetes (fasting blood glucose > 126, self-reported and/or confirmed from chart review), and Hypertension (BP > 140/90 mmHg, or on hypertensive meds); and 5) not be currently participating in any other CVD program.
排除标准
- •are pregnant (temporary exclusion-may qualify six months post partum)
- •planning to move out of the area in the next six months
- •have health problems, disabilities, or mental problems so severe as to prohibit informed consent and actual clinic/special intervention attendance. The most common abnormality that will be found on the ultrasound scans (CIMT) is extensive carotid disease. For some individuals, this may make examination of the carotid arteries very difficult. Thus, individuals will be excluded if 4) there is extensive carotid disease that precludes an accurate assessment of CIMT.
结局指标
主要结局
Change in Carotid Intimal Medial Thickness (CIMT) Measurement
时间窗: Baseline and 24-months
The CIMT measurement measures the thickness of the inner two layers of the carotid artery. The special intervention arm of this randomized trial is designed to modify multiple, modifiable cardiovascular risk factors that affect atherosclerosis and can be measured by sonography of the carotid intimal thickness.
次要结局
- Medication Adherence(Baseline and every 6-months for a maximum of 2-years)
研究者
Gregory Talavera
Professor & Division Head-Health Promotion/Behavioral Science Graduate School of Public Health
San Diego State University