NCT04746118

Diet and Other Non Pharmacological Interventions to Reduce Cardiovascular Risk in Hypertensive Patients

Effectiveness of Nutritional Intervention Alone or Associated With Other Non-pharmacological Interventions in Controlling Hypertension and Reducing Cardiovascular Risk - Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Hospital Universitário Clementino Fraga Filho · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hypertension

Interventions

Type	Name	Description
BEHAVIORAL	DIET CHANGE	Nutritional supervision will be carried out individually based on the Food Guide for the Brazilian Population, ensuring an accessible, hygienic and contextualized diet according to the subject's culture and physiology. The protocol includes an initial assessment to define the meal plan and individual reassessments every four weeks. In the first evaluation participants will receive an eating plan with a 20% reduction in the total calories consumed or even the equivalent of their daily energy needs with a distribution of macronutrients comprised of 65% carbohydrate, 15% protein and 20% fat. The intention is to promote a reduction in weekly consumption by about 2000 kilocalories (Kcal). The prescription and diet control plan will include and be conducted by a team coordinated by a clinical nutritionist.
BEHAVIORAL	PHYSICAL ACTIVITY	The physical activity program will consist of daily walking sessions performed outdoors and on a flat surface suitable for hiking. Each session will last 70 minutes and will be performed between 55% -60% of the maximum oxygen consumption (VO2), six times a week, for 24 weeks, with alternate on-site supervision on odd days and remote monitoring on even days. On-site supervision will be carried out by a team coordinated by a Physical Education teacher and implemented at two times in the morning and another two in the afternoon with meeting points previously defined. At the end of each supervised walking session, 20 minutes of exercise will be performed using the equipment available at the Senior Citizens Academy set up in public squares in the region so that the total expenditure of calories spent weekly with physical activities reach about 2000 kilocalories.
OTHER	INTEGRATIVE PRACTICES	The health integrative practices will includes Mind-Fullness, auriculotherapy and laying on of hands. A suitably qualified professional, using it use a practical manual so that the practice became uniform among the subjects, will apply the practice of Mind-Fullness in weekly 1-hour sessions to individuals. The practice of auriculotherapy will be applied to individuals by a professional qualified to perform the technique, which consists in the selection of auricular points according to the health problems presented and the therapeutic objectives that are to be achieved, followed by the insertion of the mustard seed at specific points in the ear over a six-month period. The laying on of hands will be carried out by properly trained individuals.

Timeline

• Start date: 2021-04-01
• Primary completion: 2023-01-01
• Completion: 2023-04-01
• First posted: 2021-02-09
• Last updated: 2021-02-09

Locations

1 site across 1 country: Brazil