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

NCT03793881 | Completed

• 1 other identifier: NUPRESS
• Study Type: interventional
• Target: 408
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (24)

• DBP

  6 months

• HbA1C

  6 months

• FG

  6 months

• BW

  6 months

• WC

  6 months

Other Outcomes (2)

• TT

  6 months

• AHD

  6 months

Study Arms (2)

Nutritional Strategy

EXPERIMENTAL

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

Dietary Prescription

ACTIVE COMPARATOR

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

Behavioral: Dietary Prescription

Interventions

Nutritional Strategy BEHAVIORAL

Counseling based on dietary goals and mindfulness techniques.

Nutritional Strategy

Dietary Prescription BEHAVIORAL

Dietary prescription according to guidelines.

Dietary Prescription

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital do Coracao: lead

Study Sites (8)

Universidade de Fortaleza

Fortaleza, Brazil

Location

Hospital de Clínicas de Goiás - Universidade Federal de Goiás

Goiânia, Brazil

Location

Universidade Federal de Tocantins

Palmas, Brazil

Location

Instituto de Cardiologia do Rio Grande do Sul

Porto Alegre, Brazil

Location

Pontifícia Universidade Católica do Rio Grande do Sul

Porto Alegre, Brazil

Location

Universidade de São Paulo

Ribeirão Preto, Brazil

Location

Hospital do Coracao

São Paulo, 04004-030, Brazil

Location

Hospital Comunitário São Peregrino Lazziozi

Veranópolis, Brazil

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Aline Marcadenti, PhD

  Hospital do Coracao

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: January 4, 2019
• Study Start: April 24, 2019
• Primary Completion: July 22, 2021
• Study Completion: December 30, 2022
• Last Updated: March 1, 2023

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available after main paper publication.

Locations

BR (8)