Translation of a Blood Pressure-Lowering Dietary Pattern for Hypertension Prevention and Control: A Cluster-Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Resting Systolic Blood Pressure
研究概览
简要总结
This cluster-randomized controlled trial will evaluate whether a 3-month culturally adapted blood pressure-lowering dietary, called the Eastern Blood Pressure-Lowering Diet, can improve blood pressure and related health outcomes in Chinese adults with primary hypertension.
Approximately 800 participants from 16 workplace-based clusters will be assigned to either a standard hypertension management group or a dietary intervention group. Both groups will receive usual hypertension care, including health education and medication treatment when clinically indicated. In addition, participants in the dietary intervention group will receive specially designed weekday lunches, low-sodium salt and reduced-sodium seasonings, and app-based support for dietary recording and adherence monitoring.
The main outcome is change in resting systolic and diastolic blood pressure. Other outcomes include body weight, waist circumference, body fat, blood glucose, blood lipids, homocysteine, kidney function, estimated 24-hour urinary sodium and potassium excretion, lifestyle behaviors, sleep, psychological well-being, and the occurrence of hypertension-related complications or cardiovascular and cerebrovascular events. Blood, urine, and stool samples will also be analyzed to explore possible metabolic and gut microbiome mechanisms underlying the effects of the dietary intervention.
The active dietary intervention will last 3 months, and participants will be followed for up to 24 months.
详细描述
Detailed Description
Hypertension is a major public health challenge and an important risk factor for stroke, coronary heart disease, heart failure, chronic kidney disease, and premature death. The burden of hypertension is particularly substantial among working-age populations exposed to occupational stress, high-sodium dietary patterns, frequent consumption of refined or processed foods, insufficient physical activity, and irregular lifestyles. However, evidence-based dietary approaches for lowering blood pressure are not always readily transferable to workplace settings because of differences in food culture, meal preparation practices, individual energy requirements, and the organization of food services.
This study is a pragmatic, parallel-group, cluster-randomized controlled trial designed to evaluate the effectiveness, feasibility, and potential biological mechanisms of a culturally adapted blood pressure-lowering dietary pattern, referred to as the Eastern Blood Pressure-Lowering Diet, among employees with primary hypertension in Shengli Oilfield, China. The intervention is designed to be compatible with Chinese dietary habits and implemented through an established workplace food-service system.
The study will recruit approximately 800 participants from 16 workplace clusters. Eligible participants will be adults aged 18 to 60 years who have previously been diagnosed with primary hypertension by a medical institution or who meet the diagnostic criterion of systolic blood pressure of at least 140 mmHg and/or diastolic blood pressure of at least 90 mmHg on three measurements obtained on different days. Participants are also required to regularly eat at the participating workplace canteens, generally on at least four working days per week, and to provide written informed consent.
Individuals will be excluded if they have secondary hypertension; are pregnant, breastfeeding, or planning pregnancy during the study; have a serious allergy or intolerance to major foods included in the intervention; have experienced a major cardiovascular or cerebrovascular event within the previous 6 months; have cancer, advanced kidney disease, severe liver disease, or another condition requiring a specialized therapeutic diet; have severe cardiopulmonary disease, serious psychiatric illness, major cognitive impairment, hearing impairment, or a physical disability that would substantially interfere with participation; or are otherwise considered unsuitable for participation by the investigators.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 to 60 years.
- •Employed by Shengli Oilfield and regularly receiving meals from a participating workplace canteen.
- •Regularly eats at the participating canteen, generally on at least 4 working days per week.
- •Diagnosed with primary hypertension by a qualified medical institution, or meets the diagnostic criterion of systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg on 3 measurements obtained on different days.
- •Hypertension is clinically stable.
- •Antihypertensive medication regimen is stable, when applicable.
- •Able and willing to comply with the dietary intervention, study assessments, and follow-up procedures.
- •Provides written informed consent voluntarily.
排除标准
- •Secondary hypertension.
- •Pregnancy, breastfeeding, or planning to become pregnant during the study period.
- •Serious food allergy or intolerance to major foods included in the intervention diet, such as nuts, dairy products, or gluten-containing foods.
- •Major cardiovascular or cerebrovascular event within the previous 6 months, such as myocardial infarction or stroke.
- •Severe cardiopulmonary disease, such as heart failure or severe asthma.
- •Cancer, advanced kidney disease, severe liver disease, or another serious medical condition.
- •A medical condition requiring a specialized therapeutic diet that would interfere with the study intervention.
- •Severe psychiatric illness.
- •Severe cognitive impairment that prevents understanding of the informed consent form or compliance with study procedures.
- •Hearing impairment or physical disability that would substantially interfere with participation.
- •Any other condition that, in the judgment of the research team, makes the individual unsuitable for participation.
结局指标
主要结局
Resting Systolic Blood Pressure
时间窗: Baseline and 3 month after baseline survey
Resting systolic blood pressure will be measured in millimeters of mercury (mmHg) by trained study personnel using a validated and regularly calibrated upper-arm electronic blood pressure monitor. Participants will rest in a seated position for at least 5 to 10 minutes before measurement. At least two measurements will be taken 30 to 60 seconds apart. If the difference between the first two readings exceeds 10 mmHg, a third measurement will be obtained. The mean of the valid readings will be used. The outcome is the change from baseline to the end of the 3-month intervention.
Resting Diastolic Blood Pressure
时间窗: Baseline and 3 months after baseline survey
Resting diastolic blood pressure will be measured in millimeters of mercury (mmHg) using the same standardized procedure as systolic blood pressure. At least two measurements will be obtained after seated rest, and the mean of the valid readings will be used. The outcome is the change from baseline to the end of the 3-month intervention.
次要结局
- Body Weight(Baseline& 3 months, 12 months, and 24 months after baseline survey)
- Height(Baseline& 3 months, 12 months, and 24 months after baseline survey)
- Body Mass Index(Baseline& 3 months, 12 months, and 24 months after baseline survey)
- Waist Circumference(Baseline& 3 months, 12 months, and 24 months after baseline survey)
- Body Fat Percentage(Baseline& 3 months, 12 months, and 24 months after baseline survey)
- Fasting Blood Glucose(Baseline and 3 months after baseline survey)
- Total Cholesterol(Baseline and 3 months after baseline survey)
- Triglycerides(Baseline and 3 months after Baseline survey)
- LDL Cholesterol(Baseline and 3 months after Baseline survey)
- HDL Cholesterol(Baseline and 3 months after Baseline Survey)
- Homocysteine(Baseline and 3 months after Baseline Survey)
- Estimated Urinary Sodium Excretion(Baseline and 4, 8 and 12 weeks after baseline)
- Estimated Urinary Potassium Excretion(Baseline and 4, 8 and 12 weeks after baseline)
- Kidney Function(Baseline and 3 months after Baseline Survey)
- Physical Activity(Baseline and 3 months after Baseline Survey)
- Depression, Anxiety, and Stress(Baseline and 3 months after Baseline Survey)
- Sleep Quality(Baseline and 3 months after Baseline Survey)
- Health-Related Quality of Life(Baseline and 3 months after Baseline Intervention)