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Effectiveness of a Nutritional Strategy for Blood Pressure Control in Patients With Hypertension Users of a Public Health System: NUPRESS Study
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.
Age
21 - No limit years
Sex
ALL
Healthy Volunteers
No
Universidade de Fortaleza
Fortaleza, Brazil
Hospital de Clínicas de Goiás - Universidade Federal de Goiás
Goiânia, Brazil
Universidade Federal de Tocantins
Palmas, Brazil
Instituto de Cardiologia do Rio Grande do Sul
Porto Alegre, Brazil
Pontifícia Universidade Católica do Rio Grande do Sul
Porto Alegre, Brazil
Universidade de São Paulo
Ribeirão Preto, Brazil
Hospital do Coracao
São Paulo, Brazil
Hospital Comunitário São Peregrino Lazziozi
Veranópolis, Brazil
Start Date
April 24, 2019
Primary Completion Date
July 22, 2021
Completion Date
December 30, 2022
Last Updated
March 1, 2023
408
ACTUAL participants
Nutritional Strategy
BEHAVIORAL
Dietary Prescription
BEHAVIORAL
Lead Sponsor
Hospital do Coracao
NCT02417740
NCT07073820
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07480265