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

Hospital do Coracao408 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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.

Locations (8)

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

Outcomes

Primary Outcomes

SBP

Systolic blood pressure, in mmHg

Time frame: 6 months

BPC

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.

Time frame: 6 months

Secondary Outcomes

DBP

Diastolic blood pressure, in mmHg

Time frame: 6 months

HbA1C

Glycated hemoglobin, in %

Time frame: 6 months

Fasting glucose, in mg/dL

Time frame: 6 months

Body weight, in kg

Time frame: 6 months

Waist circumference, in cm

Time frame: 6 months

BMI

Body mass index, in kg/m2; it will be defined according to the mathematical formula (BW/height\*height)

Time frame: 6 months

Total cholesterol, in mg/dL

Time frame: 6 months

LDL-c

LDL cholesterol, in mg/dL; it will be defined according to the Martin´s mathematical formula

Time frame: 6 months

HDL-c

HDL cholesterol, in mg/dL

Time frame: 6 months

Serum triglycerides, in mg/dL

Time frame: 6 months

VLDL-c

VLDL cholesterol, in mg/dL; it will be obtained according to the mathematical formula TG/5

Time frame: 6 months

NHDL

Non-HDL cholesterol, in mg/dL; it will be obtained according to the mathematical formula TC-HDL-c

Time frame: 6 months

Castelli Index I

Castelli Index I, in mg/dL; it will be obtained according to the mathematical formula TC/HDL-c

Time frame: 6 months

Castelli Index II

Castelli Index II, in mg/dL; it will be obtained according to the mathematical formula LDL-c/HDL-c

Time frame: 6 months

Creatinine, in mg/dL

Time frame: 6 months

GFR

Glomerular filtration rate, in ml/min/1.73m2

Time frame: 6 months

Sodium (s)

Serum sodium, in mEq/L

Time frame: 6 months

Sodium (u)

Urinary sodium, in mEq/L

Time frame: 6 months

Potassium (s)

Serum potassium, in mEq/L

Time frame: 6 months

Potassium (u)

Urinary potassium, in mEq/L

Time frame: 6 months

ALB

Albuminuria, in mg/g

Time frame: 6 months

Diet quality, assessed by the modified Alternative Healthy Eating Index (mAHEI)

Time frame: 6 months

MINICHAL

Quality of life evaluated by the Brazilian version of the Mini-cuestionario de calidad de vida en la hipertensión arterial. In this tool, ten items are related to the "mental status" domain and six items to "somatic manifestations". Questions refer to the past seven days. The score scale is a likert-type scale with four possible answers (0=absolutely no; 1=yes, a little; 2=yes, fairly; 3=yes, a lot). The points range from 0 (best health level) to 30 (worst health level) for the "mental status" dimension, and from 0 (best health level) to 18 (worst health level) for the "somatic manifestations" dimension.

Time frame: 6 months

SHIQ

Self-care evaluated by the Brazilian version of the Self-care of Hypertension Inventory Questionaire. This tool includes 23 items divided across 3 scales: Self-care Maintenance (11 items), Self-care Management (6 items), and Self-care Confidence (6 items). Items in the instrument are scored on a Likert-type scale. In the Self-care Maintenance domain, scores range from 1 to 5 (''never'' to ''always''). In the Self-care Management domain, 2 items range from 0 to 5 to capture a fully negative response, and other item options are scored 1 to 5. The remaining items are scored from 1 to 5 (''not likely'' to ''very likely''). In the self-care confidence scale, items are scored from 1 to 5. Scores are calculated for each scale individually. Each scale is standardized to range from 0 to 100. Self-care is considered adequate if the score is 70 or greater.

Time frame: 6 months

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

Overview

Conditions

Interventions

Eligibility

Locations (8)

Outcomes

Primary Outcomes

Secondary Outcomes