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Effectiveness of Nutritional Intervention Alone or Associated With Other Non-pharmacological Interventions in Controlling Hypertension and Reducing Cardiovascular Risk - Randomized Clinical Trial
The purpose of this study is to evaluate the effectiveness of diet change and other non-pharmacological treatments which includes physical activity and integrative therapies oriented to reduce the blood pressure in hypertensive patients.
Despite advances in the pharmaceutical industry, blood pressure control remains the biggest challenge in the treatment of hypertension in Brazil and worldwide. In this context, besides the availability and use of antihypertensive drugs, the best therapeutic approach should start with the stratification of cardiovascular risk, and contextualized modification of life habits. In this view, the present study aims to evaluate the effectiveness of diet change and other non-pharmacological treatments oriented to reduce the blood pressure in adults diagnosed with prehypertension, hypertension, and resistant hypertension. Therefore, it includes the analysis of these 3 groups: i. pre-hypertension (to evaluate strategies adopted as primary prevention); ii. hypertension in general (to assess blood pressure control and reduce cardiovascular risk reduction), and iii. resistant hypertension (individuals using 3 or more drugs without blood pressure control who have more endothelial dysfunction and target organ damage to assess secondary and tertiary prevention with possible blood pressure control, reduction in the number of drugs in use and subclinical lesions regression). Non-pharmacological approach includes adoption of healthy lifestyles, weight loss, reduced sodium intake, regular physical activity, and integrative practices capable of maintaining biopsychosocial balance. Since those interventions seems to be the best way to reach blood pressure control, we intend to use individual interventions and group actions to increase the population's adherence contributing effectively to public policies within primary care.
Age
20 - 65 years
Sex
ALL
Healthy Volunteers
No
Hospital Universitário Clementino Fraga Filho
Rio de Janeiro, Brazil
Start Date
April 1, 2021
Primary Completion Date
January 1, 2023
Completion Date
April 1, 2023
Last Updated
February 9, 2021
240
ESTIMATED participants
DIET CHANGE
BEHAVIORAL
PHYSICAL ACTIVITY
BEHAVIORAL
INTEGRATIVE PRACTICES
OTHER
Lead Sponsor
Hospital Universitário Clementino Fraga Filho
Collaborators
NCT02417740
NCT07073820
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07480265