Nutritional Strategy for Blood Pressure Control in Patients With Hypertension (NUPRESS)

Hospital do Coracao

Status: Completed

Conditions: Hypertension

Treatments: Behavioral: Dietary Prescription; Behavioral: Nutritional Strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT03793881

NUPRESS

Details and patient eligibility

About

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.

Enrollment: 408 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: ≥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.

Exclusion Criteria:

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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408 participants in 2 patient groups

Nutritional Strategy

Experimental group

Description:

Nutritional counseling based on the quality of the diet, the Food Guide for the Brazilian Population and concepts of mindfulness and mindful eating; dietary guidance based on feasible goals built together (patient and nutritionist).

Treatment:

Behavioral: Nutritional Strategy

Dietary Prescription

Active Comparator group

Description:

Individualized dietary prescription according to the guidelines of the Brazilian Society of Cardiology.

Treatment:

Behavioral: Dietary Prescription