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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Nutritional Strategy; Behavioral: Dietary Prescription

• Study Type: Interventional
• Enrollment (Actual): 408
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Fortaleza, Brazil
    • Universidade de Fortaleza
  • Goiânia, Brazil
    • Hospital de Clínicas de Goiás - Universidade Federal de Goiás
  • Palmas, Brazil
    • Universidade Federal de Tocantins
  • Porto Alegre, Brazil
    • Instituto de Cardiologia do Rio Grande do Sul
  • Porto Alegre, Brazil
    • Pontificia Universidade Católica do Rio Grande do Sul
  • Ribeirão Preto, Brazil
    • Universidade de São Paulo
  • São Paulo, Brazil, 04004-030
    • Hospital do Coracao
  • Veranópolis, Brazil
    • Hospital Comunitário São Peregrino Lazziozi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Behavioral: Nutritional Strategy; Counseling based on dietary goals and mindfulness techniques.
Active Comparator: Dietary Prescription; Individualized dietary prescription according to the guidelines of the Brazilian Society of Cardiology.	Behavioral: Dietary Prescription; Dietary prescription according to guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SBP	Systolic blood pressure, in mmHg	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1C	Glycated hemoglobin, in %	6 months
FG	Fasting glucose, in mg/dL	6 months
DBP	Diastolic blood pressure, in mmHg	6 months
HDL-c	HDL cholesterol, in mg/dL	6 months
TG	Serum triglycerides, in mg/dL	6 months
BW	Body weight, in kg	6 months
WC	Waist circumference, in cm	6 months
Cr	Creatinine, in mg/dL	6 months
GFR	Glomerular filtration rate, in ml/min/1.73m2	6 months
Sodium (s)	Serum sodium, in mEq/L	6 months
Sodium (u)	Urinary sodium, in mEq/L	6 months
Potassium (s)	Serum potassium, in mEq/L	6 months
Potassium (u)	Urinary potassium, in mEq/L	6 months
ALB	Albuminuria, in mg/g	6 months
BMI	Body mass index, in kg/m2; it will be defined according to the mathematical formula (BW/height*height)	6 months
TC	Total cholesterol, in mg/dL	6 months
LDL-c	LDL cholesterol, in mg/dL; it will be defined according to the Martin´s mathematical formula	6 months
VLDL-c	VLDL cholesterol, in mg/dL; it will be obtained according to the mathematical formula TG/5	6 months
NHDL	Non-HDL cholesterol, in mg/dL; it will be obtained according to the mathematical formula TC-HDL-c	6 months
Castelli Index I	Castelli Index I, in mg/dL; it will be obtained according to the mathematical formula TC/HDL-c	6 months
Castelli Index II	Castelli Index II, in mg/dL; it will be obtained according to the mathematical formula LDL-c/HDL-c	6 months
DQ	Diet quality, assessed by the modified Alternative Healthy Eating Index (mAHEI)	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.	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.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
TT	Therapeutic targets, defined as the proportion of participants who reached the following therapeutic targets: SBP/DBP < 140/90 mmHg; fasting glucose <100 mg/dL; LDL-c <100 mg/dL; BMI < 25 kg/m2 or weight loss > 5%	6 months
AHD	Anti-hypertensive drugs, defined as the type and proportion of anti-hypertensive drugs used	6 months

Collaborators and Investigators

• Sponsor: Hospital do Coracao
• Investigators: Principal Investigator: Aline Marcadenti, PhD, Hospital do Coracao

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2019
• Primary Completion (Actual): July 22, 2021
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: January 3, 2019
• First Submitted That Met QC Criteria: January 3, 2019
• First Posted (Actual): January 4, 2019

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: NUPRESS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data and materials will be available upon reasonable request for the corresponding author, after filling a specific form provided by IP-HCor and considering institutional data sharing politics.
• IPD Sharing Time Frame: Data will be available after main paper publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No