Diet Intervention for Hypertension: Adaptation and Dissemination to Native Communities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 315
- 试验地点
- 8
- 主要终点
- Improved blood pressure
研究概览
简要总结
We will conduct a randomized trial to test our DASH (Dietary Approaches to Stop Hypertension) based intervention in 370 adult American Indians with inadequately controlled systolic blood pressure (≥130 mmHg). Over the 5 years of the project, we will recruit and randomize 200 participants from each of 4 urban sites: two in Washington, one in Oklahoma, and one in South Dakota.
详细描述
All participants complete 3 data collection visits following an over-the-phone eligibility screening call (baseline, week 8, and week 12). Participants will be randomized into either the control group or the intervention group at the baseline visit.
All participants will receive 8 weekly credits for groceries and will be given equipment for monitoring their BP at home. Study staff will help participants place their grocery orders each week, and will collect readings from the home BP monitoring equipment at the same time. This data will be used to understand whether the intervention is effective for controlling BP.
All participants will be encouraged to maintain their regular levels of physical activity and receive treatment as usual from their healthcare providers.
The control group participants will receive an American Heart Association printed brochure about the health benefits of a low-salt diet. All foods will be available to purchase, including those that do not meet the DASH diet guidelines.
The intervention group participants will receive 1 hour of nutritional counseling over the phone and a personalized prescription for the low-salt DASH diet based on estimated calorie needs at baseline, followed by weekly 20-minute phone calls in weeks 1-8 to provide extra support.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must:
- •be at least 18 years old;
- •have had diagnosed hypertension for at least 1 year;
- •be on a stable routine of antihypertensive medications for at least 2 months OR not currently medicated, without anticipated changes for the duration of the study;
- •have systolic BP ≥ 130 mmHg at the past 2 clinic visits and at the screening call;
- •have access to regular medical care and permission from their primary care provider to participate (study staff obtain verbal permission before recruiting participants);
- •be physically and cognitively able to use the home BP monitoring device;
- •be willing and able to follow all other study procedures.
排除标准
- •People are ineligible if they:
- •experienced incident cardiovascular disease or stroke within the previous 6 months;
- •have a known diagnosis of secondary hypertension (e.g., renal artery stenosis);
- •have a recent history of high blood potassium due to certain medications that can raise potassium levels;
- •have diagnosed Stage 4 or 5 kidney disease;
- •are currently or planning to become pregnant during the course of the study;
- •are participating in another health research study involving hypertension;
- •are receiving treatment for cancer or another serious or terminal medical condition.
结局指标
主要结局
Improved blood pressure
时间窗: 12 weeks
Systolic blood pressure measurements collected throughout the study.
次要结局
- Improved blood lipids(12 weeks)
- Improved urinary sodium/potassium levels(12 weeks)
- Improved BMI(12 weeks)
研究者
Dedra Buchwald
Professor
Washington State University