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HypertensionNCT03793881

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

A study testing Nutritional Strategy and Dietary Prescription in people with Hypertension, run by Hospital do Coracao at 8 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Hypertension
What is being tested?
Nutritional Strategy and Dietary Prescription
Could I receive a placebo?
No, everyone receives an active treatment
How many people
408 participants
Where
8 sitesBrazil
Study dates
24 Apr 2019to 30 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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;
Show all 13Show fewer
  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Brazil8 sites

  • Universidade de Fortaleza

    Fortaleza

  • Hospital de Clínicas de Goiás - Universidade Federal de Goiás

    Goiânia

  • Universidade Federal de Tocantins

    Palmas

  • Instituto de Cardiologia do Rio Grande do Sul

    Porto Alegre

  • Pontifícia Universidade Católica do Rio Grande do Sul

    Porto Alegre

  • Universidade de São Paulo

    Ribeirão Preto

  • Hospital do Coracao

    São Paulo, 04004-030

  • Hospital Comunitário São Peregrino Lazziozi

    Veranópolis

Other trials in Brazil

About this study

Official title: 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.

Conditions
Hypertension
Being tested
Nutritional Strategy, Dietary Prescription
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nutritional StrategyBehavioural

    Counseling based on dietary goals and mindfulness techniques.

  • Dietary PrescriptionBehavioural

    Dietary prescription according to guidelines.

Study groups in NCT03793881
Study groupRoleWhat they receive
Nutritional StrategyExperimentalNutritional 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).
Receives: Behavioral: Nutritional Strategy
Dietary PrescriptionActive comparatorIndividualized dietary prescription according to the guidelines of the Brazilian Society of Cardiology.
Receives: Behavioral: Dietary Prescription

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SBP

    Systolic blood pressure, in mmHg

    Measured: 6 months

  2. 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.

    Measured: 6 months

Secondary outcomes (24)

  1. DBP

    Diastolic blood pressure, in mmHg

    Measured: 6 months

  2. HbA1C

    Glycated hemoglobin, in %

    Measured: 6 months

  3. FG

    Fasting glucose, in mg/dL

    Measured: 6 months

  4. BW

    Body weight, in kg

    Measured: 6 months

  5. WC

    Waist circumference, in cm

    Measured: 6 months

  6. BMI

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

    Measured: 6 months

  7. TC

    Total cholesterol, in mg/dL

    Measured: 6 months

  8. LDL-c

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

    Measured: 6 months

  9. HDL-c

    HDL cholesterol, in mg/dL

    Measured: 6 months

  10. TG

    Serum triglycerides, in mg/dL

    Measured: 6 months

  11. VLDL-c

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

    Measured: 6 months

  12. NHDL

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

    Measured: 6 months

  13. Castelli Index I

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

    Measured: 6 months

  14. Castelli Index II

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

    Measured: 6 months

  15. Cr

    Creatinine, in mg/dL

    Measured: 6 months

  16. GFR

    Glomerular filtration rate, in ml/min/1.73m2

    Measured: 6 months

  17. Sodium (s)

    Serum sodium, in mEq/L

    Measured: 6 months

  18. Sodium (u)

    Urinary sodium, in mEq/L

    Measured: 6 months

  19. Potassium (s)

    Serum potassium, in mEq/L

    Measured: 6 months

  20. Potassium (u)

    Urinary potassium, in mEq/L

    Measured: 6 months

  21. ALB

    Albuminuria, in mg/g

    Measured: 6 months

  22. DQ

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

    Measured: 6 months

  23. 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.

    Measured: 6 months

  24. 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2019
  2. Study start24 Apr 2019
  3. Primary completion22 Jul 2021
  4. Study completion30 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
408 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03793881
Sponsor's protocol ID
NUPRESS
Status last verified
Feb 2022
First submitted
3 Jan 2019
Last updated
1 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Holzbach LC, Marcadenti A, Bersch-Ferreira AC, Machado RHV, Carvalho APPF, Pinto SL, Penafort AM, Coelho ASG, Cominetti C. Polygenic risk scores predict blood pressure changes independent of dietary intervention: a secondary analysis of the NUPRESS trial. Eur J Nutr. 2026 Aug 1;65(5):225. doi: 10.1007/s00394-026-04072-x.

    PubMed 42541580

Questions about this trial

What is this clinical trial studying?

A study testing Nutritional Strategy and Dietary Prescription in people with Hypertension, run by Hospital do Coracao at 8 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SBP (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03793881, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.

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