Ignite Creation Date:
2024-05-06 @ 12:35 PM
Last Modification Date:
2024-10-26 @ 1:01 PM
Study NCT ID:
NCT03793881
Status:
COMPLETED
Last Update Posted:
2023-03-01
First Post:
2019-01-03
Brief Title:
Nutritional Strategy for Blood Pressure Control in Patients With Hypertension NUPRESS
Sponsor:
Hospital do Coracao
Organization:
Hospital do Coracao
Study Overview
Official Title:
Effectiveness of a Nutritional Strategy for Blood Pressure Control in Patients With Hypertension Users of a Public Health System NUPRESS Study
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None