Effectiveness of a Nutritional Strategy for Blood Pressure Control in Patients With Hypertension Users of a Public Health System: NUPRESS Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 408
- 试验地点
- 9
- 主要终点
- SBP
研究概览
简要总结
Adherence to a healthy dietary pattern is part of the self-care of patients with hypertension, and may contribute substantially to therapeutic target goals as well as to a better quality of life. However, not all nutritional recommendations aimed at these patients are easily applicable in clinical practice. The primary objective of the study is to evaluate the effectiveness of a nutritional strategy for blood pressure control in patients with hypertension users of a Public Health System after 6 months of follow-up. As secondary objectives, we will evaluate the impact of the proposed strategy on self-care and on the quality of life of the patients. In this multicenter open-label randomized trial, 408 patients ≥21 years old with hypertension, systolic blood pressure (SBP) ≥140mmHg at the moment of the screening and who have not received or received nutritional counseling for at least 06 months will be enrolled. Patients allocated to the control group will receive individualized dietary prescription according to the guidelines of the Brazilian Society of Cardiology. Nutritional counseling in the intervention group will be performed based on the quality of the diet, the Food Guide for the Brazilian Population and concepts of mindfulness and mindful eating; all dietary guidance will be based on feasible goals built together (patient and nutritionist), and no diet will be prescribed for intervention group. In both groups, patients will receive automatic monitors for residential self-monitoring blood pressure. On-site follow-up visits will be carried out at 30, 60, 90, and 180 days (final consultation). At 120 and 150 days, participants in the intervention group will receive motivational messages via e-mail or SMS (for these patients, consultation of 30 days will be a group meeting). Laboratory tests (lipid and glycemic profile, serum creatinine, serum sodium, urinary sodium, serum potassium, urinary potassium and albuminuria) will be performed at baseline and 180 days; anthropometric indexes and diastolic blood pressure (DBP) will be also evaluated.
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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥21 years old with medical diagnosis of hypertension, systolic blood pressure (SBP) ≥140 mmHg at the moment of the screening and who have not received or received nutritional counseling for at least 06 months.
排除标准
- •Diagnosis of resistant and/or secondary hypertension;
- •Severe neuropathy;
- •Chronic kidney disease;
- •Active cancer or life expectancy <6 months;
- •Chemical dependence or use of antipsychotic drugs;
- •Autoimmune disease or chronic use of steroids;
- •Pregnancy and lactation;
- •Acute coronary syndrome in the last 60 days;
- •Severe or unstable heart failure;
- •Wheelchair users;
- •Extreme obesity (body mass index [BMI] ≥40kg / m²);
- •Cognitive, neurological or psychiatric condition that prevents participation in the study;
- •Participation in other clinical trials.
结局指标
主要结局
SBP
时间窗: 6 months
Systolic blood pressure, in mmHg
BPC
时间窗: 6 months
Blood pressure control, defined as either having systolic blood pressure (SBP) \> 140 mmHg at baseline and achieving SBP ≤ 140 mmHg after follow-up or having SBP ≤ 140 mmHg at baseline and reducing anti-hypertensive drugs after follow-up.
次要结局
- Cr(6 months)
- GFR(6 months)
- DBP(6 months)
- HbA1C(6 months)
- FG(6 months)
- BW(6 months)
- BMI(6 months)
- HDL-c(6 months)
- Potassium (u)(6 months)
- ALB(6 months)
- DQ(6 months)
- Castelli Index I(6 months)
- WC(6 months)
- VLDL-c(6 months)
- TC(6 months)
- LDL-c(6 months)
- TG(6 months)
- NHDL(6 months)
- Castelli Index II(6 months)
- Potassium (s)(6 months)
- Sodium (s)(6 months)
- Sodium (u)(6 months)
- MINICHAL(6 months)
- SHIQ(6 months)