Location-based Tailored Messaging to Reduce Sodium Intake in Hypertensive Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 24-hour urinary sodium excretion
研究概览
简要总结
The proposed study will determine the effectiveness of a mobile application location-based tailored notification message system in helping hypertensive patients reduce dietary sodium intake and feel more confident in following a low sodium diet.
详细描述
People with high blood pressure often get advice to lower their salt or sodium intake. High dietary sodium intake is linked to high blood pressure, stroke, heart failure and kidney disease. U.S. federal guidelines advocate daily sodium intake of less than 2,300 milligrams (mg). The estimated average sodium intake for Americans is 3,400 mg per day. In recent years, consumption of processed and restaurant foods has substantially increased. More than 75% of sodium in the average U.S. diet now comes from these sources.
The mobile application will deliver tailored messages based on the user's location and previously identified high-sodium food items that they commonly consume.
This 8-week research study at Visit 1 or baseline will consent and randomize 50 eligible adults with high blood pressure to use the mobile application daily or to follow their usual eating pattern with no access to the application.
All participants will be asked to complete four surveys at baseline and Week 8: Block Food Frequency Questionnaire, Block Sodium Screener, Self-care Confidence in following a Low Sodium Diet and the Automated Self-administered 24-Hour Dietary Recall survey. All participants will be asked to provide a baseline and end of study 24-hour urine collection, regularly provide home blood pressure measurements and urine dipstick tests every two weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 否
入选标准
- •> 18 years of age
- •Hypertension
- •Use of anti-hypertensive therapy for at least 3 months, with stable anti-hypertensive therapy (medication type and dose) for at least 2 weeks
- •Daily sodium intake of >2,000 mg with sodium to kcal ratio > 1, estimated via Food Frequency Questionnaire
- •Ownership and use of an Apple iPhone
排除标准
- •Chronic Kidney Disease
- •Heart Failure
- •Systolic Blood Pressure >180 mm Hg
- •Diastolic Blood Pressure >110 mm Hg
- •Use of a loop diuretic or corticosteroid
- •Insulin dependent diabetes mellitus
研究组 & 干预措施
Location-based Tailored Messaging
Participants receive location-based tailored messaging via a mobile application throughout the 8-week research study.
干预措施: Location-based Tailored Messaging (Behavioral)
Control Group
Participants follow their usual eating pattern and will not have access to the application throughout the 8-week research study.
结局指标
主要结局
24-hour urinary sodium excretion
时间窗: Baseline, Week 8
Change from baseline in 24-hour urinary sodium excretion at week 8
Self-care Confidence in Following a Low-sodium Diet Scale (SCFLDS)
时间窗: Baseline, Week 8
Change from baseline in Self-care Confidence in Following a Low-sodium Diet Scale (SCFLDS) at week 8. It assesses the participants' confidence in the ability to select and prepare low-sodium foods. The self-reported tool consists of 7 items with 4 response options per item. The score range is 1-4 (1=Not confident, 2=Somewhat confident, 3=Very confident, 4=Extremely confident) then added for each question. Possible scores range from 7 to 28 and the higher the score indicates greater confidence.
次要结局
未报告次要终点
研究者
Scott L. Hummel
MD MS Assistant Professor Internal Medicine Cardiology
University of Michigan