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

• ClinicalTrials.gov Identifier: NCT03793881
• Recruitment Status: Active, not recruiting
• First Posted: January 4, 2019
• Last Update Posted: March 9, 2022
• Sponsor: Hospital do Coracao
• Information provided by (Responsible Party): Hospital do Coracao

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hypertension	Behavioral: Nutritional Strategy; Behavioral: Dietary Prescription	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 408 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effectiveness of a Nutritional Strategy for Blood Pressure Control in Patients With Hypertension Users of a Public Health System: NUPRESS Study
• Actual Study Start Date: April 24, 2019
• Actual Primary Completion Date: July 22, 2021
• Estimated Study Completion Date: December 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. SBP [ Time Frame: 6 months ]
   Systolic blood pressure, in mmHg. Blood pressure control will be considered if the participant decreases the medication during the study and maintains SBP at the end of the follow-up; or if the patient maintains the medication throughout the study and decreases SBP at the end of the follow-up.

Secondary Outcome Measures :

1. DBP [ Time Frame: 6 months ]
   Diastolic blood pressure, in mmHg
2. 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.
3. 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.
4. HbA1C [ Time Frame: 6 months ]
   Glycated hemoglobin, in %
5. FG [ Time Frame: 6 months ]
   Fasting glucose, in mg/dL
6. BW [ Time Frame: 6 months ]
   Body weight, in kg
7. WC [ Time Frame: 6 months ]
   Waist circumference, in cm
8. BMI [ Time Frame: 6 months ]
   Body mass index, in kg/m2; it will be defined according to the mathematical formula (BW/height*height)
9. TC [ Time Frame: 6 months ]
   Total cholesterol, in mg/dL
10. LDL-c [ Time Frame: 6 months ]
    LDL cholesterol, in mg/dL; it will be defined according to the Martin´s mathematical formula
11. HDL-c [ Time Frame: 6 months ]
    HDL cholesterol, in mg/dL
12. TG [ Time Frame: 6 months ]
    Serum triglycerides, in mg/dL
13. VLDL-c [ Time Frame: 6 months ]
    VLDL cholesterol, in mg/dL; it will be obtained according to the mathematical formula TG/5
14. NHDL [ Time Frame: 6 months ]
    Non-HDL cholesterol, in mg/dL; it will be obtained according to the mathematical formula TC-HDL-c
15. 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
16. 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

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

Brazil

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, 04004-030

Hospital Comunitário São Peregrino Lazziozi

Veranópolis, Brazil

Sponsors and Collaborators

Hospital do Coracao

Investigators

• Principal Investigator: Aline Marcadenti, PhD; Hospital do Coracao

More Information

• Responsible Party: Hospital do Coracao
• ClinicalTrials.gov Identifier: NCT03793881
• Other Study ID Numbers: NUPRESS
• First Posted: January 4, 2019
• Last Update Posted: March 9, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Time Frame: Data will be available after main paper publication.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases