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Completed

NCT Number: NCT03793881

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

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade de Fortaleza, Fortaleza, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nutritional Strategy

Behavioral

Counseling based on dietary goals and mindfulness techniques.

Dietary Prescription

Behavioral

Dietary prescription according to guidelines.

Primary outcomes

  1. SBP

    Time frame: 6 months

    Systolic blood pressure, in mmHg

  2. BPC

    Time frame: 6 months

    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.

Secondary outcomes

  1. DBP

    Time frame: 6 months

    Diastolic blood pressure, in mmHg

  2. HbA1C

    Time frame: 6 months

    Glycated hemoglobin, in %

  3. FG

    Time frame: 6 months

    Fasting glucose, in mg/dL

  4. BW

    Time frame: 6 months

    Body weight, in kg

  5. WC

    Time frame: 6 months

    Waist circumference, in cm

  6. BMI

    Time frame: 6 months

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

  7. TC

    Time frame: 6 months

    Total cholesterol, in mg/dL

  8. LDL-c

    Time frame: 6 months

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

  9. HDL-c

    Time frame: 6 months

    HDL cholesterol, in mg/dL

  10. TG

    Time frame: 6 months

    Serum triglycerides, in mg/dL

  11. VLDL-c

    Time frame: 6 months

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

  12. NHDL

    Time frame: 6 months

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

  13. Castelli Index I

    Time frame: 6 months

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

  14. Castelli Index II

    Time frame: 6 months

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

  15. Cr

    Time frame: 6 months

    Creatinine, in mg/dL

  16. GFR

    Time frame: 6 months

    Glomerular filtration rate, in ml/min/1.73m2

  17. Sodium (s)

    Time frame: 6 months

    Serum sodium, in mEq/L

  18. Sodium (u)

    Time frame: 6 months

    Urinary sodium, in mEq/L

  19. Potassium (s)

    Time frame: 6 months

    Serum potassium, in mEq/L

  20. Potassium (u)

    Time frame: 6 months

    Urinary potassium, in mEq/L

  21. ALB

    Time frame: 6 months

    Albuminuria, in mg/g

  22. DQ

    Time frame: 6 months

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

  23. MINICHAL

    Time frame: 6 months

    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.

  24. SHIQ

    Time frame: 6 months

    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.

Other outcomes

  1. TT

    Time frame: 6 months

    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%

  2. AHD

    Time frame: 6 months

    Anti-hypertensive drugs, defined as the type and proportion of anti-hypertensive drugs used

Sponsors and collaborators

Lead sponsor

Hospital do Coracao

Other

Registry information

Official study title

Effectiveness of a Nutritional Strategy for Blood Pressure Control in Patients With Hypertension Users of a Public Health System: NUPRESS Study

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jan 4, 2019
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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