Stroke Health and Risk Education (SHARE)
关键词
抽象
描述
The study is a randomized, parallel group, behavioral intervention trial designed to reduce stroke risk. The assembled investigative team has outstanding relevant experience in epidemiology, behavioral intervention, health services clinical trials, and medicine. The target populations are Mexican Americans (MA) and European Americans (EA) living in a medium size U.S. city, Corpus Christi, Texas. We have extensive experience conducting research in this community. In fact we have run two highly successful, NIH-funded projects in Corpus Christi. The proposed study is a true partnership of investigators from the University of Michigan, who have worked in this community for 14 years, and the Diocese of Corpus Christi. The primary outcome in this stroke prevention project will include key stroke risk factors: sodium intake, fruit and vegetable intake, and physical activity. Churches have been recruited (100% cooperation rate) and will be randomized to intervention and control groups. A theory-based, scientific, rigorous, behavioral intervention was carefully crafted. In addition to theory and investigators' experience in this community, project development involved a pilot study of risk factor data collection from Church goers, and detailed focus groups from a different group of Church members and clergy.
Specific aim: To test the effectiveness of a culturally-sensitive, church-based, multicomponent, behavioral intervention for Mexican Americans and European Americans in reducing important behavioral and biological stroke risk factors.
Hypothesis 1: Participants randomized to the intervention group will have more optimized behavioral risk factors including a greater reduction in sodium intake, greater increase in dietary fruit and vegetable intake, and greater increase in physical activity than those in the control group (primary outcome).
Hypothesis 2: Participants randomized to the intervention group will have a greater reduction in systolic blood pressure than those in the control group (secondary outcome).
Hypothesis 3: Participants randomized to the intervention group will have greater reductions in other stroke risk factors such as diastolic blood pressure, fasting serum glucose, body mass index, fasting LDL cholesterol and greater increases in HDL cholesterol than those in the control group (exploratory outcomes).
Hypothesis 4: In exploratory analysis, there will be no interaction between intervention group and ethnicity within a culturally-sensitive, church-based, multicomponent, behavioral intervention to alter sodium intake, fruit and vegetable intake, and physical activity level.
日期
| 最后验证: | 03/31/2015 |
| 首次提交: | 06/14/2011 |
| 提交的预估入学人数: | 06/20/2011 |
| 首次发布: | 06/21/2011 |
| 上次提交的更新: | 04/26/2015 |
| 最近更新发布: | 04/27/2015 |
| 实际学习开始日期: | 04/30/2011 |
| 预计主要完成日期: | 11/30/2013 |
| 预计完成日期: | 11/30/2013 |
状况或疾病
干预/治疗
Behavioral: Intervention for diet, exercise
Behavioral: Control
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: Intervention for diet, exercise This group will receive the educational intervention for healthy diet and increased physical activity | Behavioral: Intervention for diet, exercise The proposed project, SHARE, is a culturally-tailored, primary stroke prevention intervention for MAs and EAs that targets a number of health-related behaviors related to stroke risk. Using a combination of self-help materials, social support, peer counseling based on Motivational interviewing, tailored newsletters, and social environmental changes in Catholic Churches, the SHARE intervention will lead to increases in moderate and vigorous intensity physical activity, decreases in salt intake, and increases in fruit and vegetable intake. Additional targets include decreases in BMI for those overweight or obese, reduction of dietary fat (trans, saturated and total fat), and increases in low-fat dairy products, changes that will serve to reduce blood pressure and stroke risk. Additionally, SHARE will seek to improve hypertension medication adherence in participants with previously diagnosed high blood pressure at baseline screening. |
| Other: Control This group will get a skin cancer awareness educational message. At the end of the study this group will also receive the diet and exercise intervention but outcomes will not be measured after the crossover. | Behavioral: Control Control group will get the diet and physical activity intervention after the crossover but no outcomes will be measured after the crossover |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Participants will be European American or Mexican American residents of Corpus Christi, Texas area and member of a Catholic Church participating in the study - greater than 18 years of age - speak English or Spanish - willing to provide a mailing address and home telephone number to study personnel at the time of consent - participants must be able to identify a friend or family partner who is also willing to participate in the study - to avoid second level clustering, only two individuals per household (the first to enroll) will be eligible Exclusion Criteria: - Known pregnancy is an exclusion criterion. |
结果
主要结果指标
1. Sodium intake [12 months]
2. Fruit/vegetable intake [12 months]
3. Physical activity [12 months]
次要成果指标
1. Systolic blood pressure [12 months]
