Using Digital Health to Improve Diet Quality Among Adults at Risk for Cardiovascular Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 301
- 试验地点
- 2
- 主要终点
- Change in Dietary Intake as Measured by Dietary Approaches to Stop Hypertension (DASH) Score
研究概览
简要总结
The goal of Nourish is to help adults with high blood pressure enjoy an eating pattern called DASH (Dietary Approaches to Stop Hypertension) to lower blood pressure and improve health. Nourish will use a mobile app and information about DASH to help study participants follow the DASH dietary plan by tracking what they eat and drink every day. The primary outcome of the study is 6-month change in following the DASH eating plan, as measured by 24-hour dietary recalls. The secondary outcome is change in blood pressure. Study participation will last one year.
详细描述
Over 100 million Americans suffer from high blood pressure and are at increased risk for cardiovascular disease. Evidence supports the DASH (Dietary Approaches to Stop Hypertension) dietary pattern to reduce blood pressure. DASH is rich in fruits and vegetables, legumes, lean protein, and low-fat dairy, and reduced in red meats, sweets and processed foods. The Nourish trial will look at the effect of the intervention on changes in dietary quality and blood pressure among men and women with high blood pressure. Participants who join Nourish will be asked to track what they eat and drink every day through a smartphone app and to participate in online study visits. Some participants will also receive additional support from a registered dietitian. We are doing this study to understand how technology can help adults with high blood pressure follow a heart-healthy eating plan to improve their blood pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systolic blood pressure of 120-159 mmHg or diastolic blood pressure of 80-99 mmHg, whether or not taking blood pressure medications.
- •BMI ≥ 18.5 kg/m2
- •Smartphone with a data plan
- •Willing to receive daily text messages
- •Valid email address
- •Willing and able to participate in online study videoconferencing visits (Zoom)
- •Lives in the U.S.
- •Reads and writes in English
排除标准
- •Participating in another related research study
- •Cardiovascular disease event (e.g. stroke, myocardial infarction) in prior 6 months
- •Bariatric surgery in the last 12 months or planned during the study period
- •Active cancer
- •Recent hospitalization due to psychiatric condition or event
- •Pregnancy- current or planned during the study period
- •Documented dementia
- •Lives with someone else participating in the Nourish study
- •To learn more about the study and to see if eligible to participate, visit www.nourishstudy.org
结局指标
主要结局
Change in Dietary Intake as Measured by Dietary Approaches to Stop Hypertension (DASH) Score
时间窗: Baseline and 6 months
Participants entered their dietary intake online via the National Cancer Institute's Automated Self-Administered 24-hour (ASA24) Dietary Assessment tool to record 2 separate 24-hour dietary recalls (1 weekday and 1 weekend day). DASH dietary nutrients are then converted into a score using the method described in Mellen et al (2008). Scores ranged from 0 to 9 where a higher score indicates better adherence to the DASH dietary pattern. Change in DASH score = 6-month DASH score - Baseline DASH score.
次要结局
- Change in Diastolic Blood Pressure(Baseline and 6 months)
- Change in Systolic Blood Pressure(Baseline and 6 months)