Clinical trial NCT03793881: Nutritional Strategy for Blood Pressure Control in Patients With Hypertension (NUPRESS)
Official title: Effectiveness of a Nutritional Strategy for Blood Pressure Control in Patients With Hypertension Users of a Public Health System: NUPRESS Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Hospital do Coracao
Sponsor class: OTHER
First posted: 2019-01-04
Enrollment: 408
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: SBP
timeFrame: 6 months
measure: BPC
timeFrame: 6 months
Secondary outcomes:
measure: DBP
timeFrame: 6 months
measure: HbA1C
timeFrame: 6 months
measure: FG
timeFrame: 6 months
measure: BW
timeFrame: 6 months
measure: WC
timeFrame: 6 months
measure: BMI
timeFrame: 6 months
measure: TC
timeFrame: 6 months
measure: LDL-c
timeFrame: 6 months
measure: HDL-c
timeFrame: 6 months
measure: TG
timeFrame: 6 months
measure: VLDL-c
timeFrame: 6 months
measure: NHDL
timeFrame: 6 months
measure: Castelli Index I
timeFrame: 6 months
measure: Castelli Index II
timeFrame: 6 months
measure: Cr
timeFrame: 6 months
measure: GFR
timeFrame: 6 months
measure: Sodium (s)
timeFrame: 6 months
measure: Sodium (u)
timeFrame: 6 months
measure: Potassium (s)
timeFrame: 6 months
measure: Potassium (u)
timeFrame: 6 months
measure: ALB
timeFrame: 6 months
measure: DQ
timeFrame: 6 months
measure: MINICHAL
timeFrame: 6 months
measure: SHIQ
timeFrame: 6 months
Other outcomes:
measure: TT
timeFrame: 6 months
measure: AHD
timeFrame: 6 months
Locations:
city: Fortaleza
country: Brazil
facility: Universidade de Fortaleza
city: Goiânia
country: Brazil
facility: Hospital de Clínicas de Goiás - Universidade Federal de Goiás
city: Palmas
country: Brazil
facility: Universidade Federal de Tocantins
city: Porto Alegre
country: Brazil
facility: Instituto de Cardiologia do Rio Grande do Sul
city: Porto Alegre
country: Brazil
facility: Pontifícia Universidade Católica do Rio Grande do Sul
city: Ribeirão Preto
country: Brazil
facility: Universidade de São Paulo
city: São Paulo
country: Brazil
facility: Hospital do Coracao
city: Veranópolis
country: Brazil
facility: Hospital Comunitário São Peregrino Lazziozi
Study officials:
affiliation: Hospital do Coracao
name: Aline Marcadenti, PhD
role: PRINCIPAL_INVESTIGATOR
References: