Clinical Trials Logo

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 1 year 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 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, 180, 270 and 360 days (final consultation). At 120, 150, 210, 240, 300 and 330 days, participants in the intervention group will receive motivational messages via e-mail or SMS (for these patients, consultations of 30 and 270 days will be group meetings). Laboratory tests (lipid and glycemic profile, serum creatinine, serum sodium, urinary sodium, serum potassium, urinary potassium and albuminuria) will be performed at baseline, 180 and 360 days; anthropometric indexes and diastolic blood pressure (DBP) will be also evaluated.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT03793881
Study type Interventional
Source Hospital do Coracao
Contact Aline Marcadenti, PhD
Phone (+55)11 30536611
Status Not yet recruiting
Phase N/A
Start date February 2019
Completion date December 2020

See also
  Status Clinical Trial Phase
Completed NCT03093532 - A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities N/A
Recruiting NCT03632668 - Evaluating the Pharmacokinetic Interaction Between AD-2071 and AD-2072 Phase 1
Recruiting NCT02699645 - Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial Phase 3
Completed NCT03170752 - Implementing and Testing a Cardiovascular Assessment Screening Program (CASP) N/A
Recruiting NCT03660631 - Dissemination of the Cardiovascular Risk Service N/A
Recruiting NCT03266510 - Inspiratory Muscle Strength Training to Improve Blood Pressure and Physiological Function N/A
Recruiting NCT02796313 - Diet Intervention for Hypertension: Adaptation and Dissemination to Native Communities N/A
Completed NCT00508365 - Evaluation of Potential for Orthostatic Hypotension in Elderly Hypertensives Phase 1
Completed NCT00382564 - Magnetic Resonance Angiography to Diagnose Atherosclerotic Disease N/A
Recruiting NCT03503773 - The TARGET BP OFF-MED Trial Phase 2
Not yet recruiting NCT03678207 - The Effectiveness of a Preoperative Blood Pressure Screening Program to Identify Undiagnosed Hypertension in Ambulatory Surgery Patients
Recruiting NCT03249753 - The Effect of Food Intake on the Pharmacokinetic of Single Dose SPH3127 Tablets in Chinese Health Subjects Phase 1
Completed NCT03100812 - Asian American Partnerships in Research and Empowerment (AsPIRE) N/A
Recruiting NCT03099343 - Tailored Messaging to Reduce Sodium Intake N/A
Active, not recruiting NCT03288142 - The Smart Hypertension Control Study N/A
Completed NCT02147626 - Heart Health 4 Moms N/A
Not yet recruiting NCT03661177 - Reclaiming Indigenous Food and Health N/A
Enrolling by invitation NCT03683186 - A Study Evaluating the Long-Term Safety and Efficacy of Ralinepag in Subjects With PAH Via an Open-Label Extension Phase 3
Not yet recruiting NCT01620788 - Comparison of Losartan Associated With Indapamide Versus Hyzaar® in the Hypertension Treatment Phase 3
Not yet recruiting NCT03293147 - OUTREACH: Urine Analysis and Antihypertensive Treatment N/A