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

Hospital Universitário Clementino Fraga Filho

Status: Unknown

Conditions: Hypertension

Treatments: Behavioral: DIET CHANGE; Behavioral: PHYSICAL ACTIVITY; Other: INTEGRATIVE PRACTICES

Study type: Interventional

Funder types: Other

Identifiers

NCT04746118

41740720.7.1001.5257

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Individuals of both sexes aged between 20 and 65 years old;
• Resistant hypertensive individuals: hypertensive individuals using 3 antihypertensive drugs or more without control of office blood pressure (BP ≥ 140 x 90 mmHg) or using 4 drugs with pressure control in follow-up at Hypertension Program (ProHArt) - University Hospital (HUCFF) - Federal University of Rio de Janeiro (UFRJ).
• Pre-hypertensive individuals: individuals with systolic blood pressure (SBP) between 121-139 mmHg and / or diastolic blood pressure (DBP) between 81-89 mmHg without the use of antihypertensive drugs registered at Family Health Strategy unit.
• Hypertensive: individuals with SBP ≥ 140 mmHg and / or DBP ≥ 90 mmHg or using antihypertensive drugs registered at Family Health Strategy unit.
• Individuals who accept to participate in the research after signing the Free and Informed Consent Form

Exclusion criteria

• Pregnant;
• Major cardiovascular events (acute myocardial infarction, unstable angina, stroke) in the last 6 months;
• Individuals with psychiatric illnesses or significant cognitive impairment;
• Individuals with clinical conditions that preclude physical activity such as severe peripheral arterial disease, advanced osteoarticular disease, neurological degenerative disease, severe muscle disease;
• Individuals who have undergone weight loss procedures (diet or medication) in the last 6 months;
• Individuals who have undergone surgical procedures for weight loss;
• Individuals who are participating in any other intervention study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 4 patient groups

CONTROL

No Intervention group

Description:

During routine clinical visits the patients will receive a written standard general guidelines for diet and physical activity.

DIET CHANGE

Experimental group

Description:

In scheduled nutritional care the patients will receive an individual program with social media supervision. Those patients will also receive a written general guidelines for exercising without supervision.

Treatment:

Behavioral: DIET CHANGE

DIET CHANGE + PHYSICAL ACTIVITY

Experimental group

Description:

In scheduled nutritional care the patients will receive an individual program with social media supervision. Those patients will also receive an exercise physical program prescription with fitness evaluation and close supervision.

Treatment:

Behavioral: PHYSICAL ACTIVITY

Behavioral: DIET CHANGE

DIET CHANGE + PHYSICAL ACTIVITY + INTEGRATIVE PRACTICES

Experimental group

Description:

In scheduled nutritional care the patients will receive an individual program with social media supervision. Those patients will also receive an exercise physical program prescription with fitness evaluation and close supervision and submitted to orientated mind-fullness, auriculotherapy and "laying on of hands" approaches that belong to health integrative practices.

Treatment:

Other: INTEGRATIVE PRACTICES

Behavioral: PHYSICAL ACTIVITY

Behavioral: DIET CHANGE