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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

408 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-24

Study Completion Date

2022-12-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nutritional Strategy

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).

Group Type EXPERIMENTAL

Nutritional Strategy

Intervention Type BEHAVIORAL

Counseling based on dietary goals and mindfulness techniques.

Dietary Prescription

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

Group Type ACTIVE_COMPARATOR

Dietary Prescription

Intervention Type BEHAVIORAL

Dietary prescription according to guidelines.

Interventions

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Nutritional Strategy

Counseling based on dietary goals and mindfulness techniques.

Intervention Type BEHAVIORAL

Dietary Prescription

Dietary prescription according to guidelines.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No