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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03793881
• Other study ID #: NUPRESS
• Status: Completed
• Phase: N/A
• Start date: April 24, 2019
• Est. completion date: December 30, 2022

Study information

• Verified date: February 2022
• Source: Hospital do Coracao
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 408
• Est. completion date: December 30, 2022
• Est. primary completion date: July 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• Nutritional Strategy
Counseling based on dietary goals and mindfulness techniques.
• Dietary Prescription
Dietary prescription according to guidelines.

Locations

Country	Name	City	State
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	Hospital Comunitário São Peregrino Lazziozi	Veranópolis

Sponsors (1)

Lead Sponsor	Collaborator
Hospital do Coracao

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	TT	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%	6 months
Other	AHD	Anti-hypertensive drugs, defined as the type and proportion of anti-hypertensive drugs used	6 months
Primary	SBP	Systolic blood pressure, in mmHg	6 months
Primary	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	DBP	Diastolic blood pressure, in mmHg	6 months
Secondary	HbA1C	Glycated hemoglobin, in %	6 months
Secondary	FG	Fasting glucose, in mg/dL	6 months
Secondary	BW	Body weight, in kg	6 months
Secondary	WC	Waist circumference, in cm	6 months
Secondary	BMI	Body mass index, in kg/m2; it will be defined according to the mathematical formula (BW/height*height)	6 months
Secondary	TC	Total cholesterol, in mg/dL	6 months
Secondary	LDL-c	LDL cholesterol, in mg/dL; it will be defined according to the Martin´s mathematical formula	6 months
Secondary	HDL-c	HDL cholesterol, in mg/dL	6 months
Secondary	TG	Serum triglycerides, in mg/dL	6 months
Secondary	VLDL-c	VLDL cholesterol, in mg/dL; it will be obtained according to the mathematical formula TG/5	6 months
Secondary	NHDL	Non-HDL cholesterol, in mg/dL; it will be obtained according to the mathematical formula TC-HDL-c	6 months
Secondary	Castelli Index I	Castelli Index I, in mg/dL; it will be obtained according to the mathematical formula TC/HDL-c	6 months
Secondary	Castelli Index II	Castelli Index II, in mg/dL; it will be obtained according to the mathematical formula LDL-c/HDL-c	6 months
Secondary	Cr	Creatinine, in mg/dL	6 months
Secondary	GFR	Glomerular filtration rate, in ml/min/1.73m2	6 months
Secondary	Sodium (s)	Serum sodium, in mEq/L	6 months
Secondary	Sodium (u)	Urinary sodium, in mEq/L	6 months
Secondary	Potassium (s)	Serum potassium, in mEq/L	6 months
Secondary	Potassium (u)	Urinary potassium, in mEq/L	6 months
Secondary	ALB	Albuminuria, in mg/g	6 months
Secondary	DQ	Diet quality, assessed by the modified Alternative Healthy Eating Index (mAHEI)	6 months
Secondary	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.	6 months
Secondary	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.	6 months