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

Not Applicable

• Conditions: Hypertension
• Interventions: Behavioral: DIET CHANGE; Behavioral: PHYSICAL ACTIVITY; Other: INTEGRATIVE PRACTICES

• Registration Number: NCT04746118
• Lead Sponsor: Hospital Universitário Clementino Fraga Filho

Brief 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.

Study Timeline

• Study First Submitted: 2021-01-26
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-04
• Last Update Submitted: 2021-02-04
• Study First Posted: 2021-02-09
• Last Update Posted: 2021-02-09
• Study Start: 2021-04
• Primary Completion: 2023-01
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DIET CHANGE	DIET CHANGE	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.
DIET CHANGE + PHYSICAL ACTIVITY	DIET CHANGE	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.
DIET CHANGE + PHYSICAL ACTIVITY	PHYSICAL ACTIVITY	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.
DIET CHANGE + PHYSICAL ACTIVITY + INTEGRATIVE PRACTICES	DIET CHANGE	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.
DIET CHANGE + PHYSICAL ACTIVITY + INTEGRATIVE PRACTICES	PHYSICAL ACTIVITY	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.
DIET CHANGE + PHYSICAL ACTIVITY + INTEGRATIVE PRACTICES	INTEGRATIVE PRACTICES	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.

Primary Outcome Measures

Name	Time	Method
Blood pressure	21 months	Indicators: Office blood pressure and Home Blood Pressure Monitoring (HBPM) after 6 months of non-pharmacological intervention Goals: Nutritional strategy: reduction of 1 mmHg by reducing each kg of body weight and reducing salt intake reaching \<1.5 g / day with a reduction of 2 to 3 mmHg.; Physical activity: reduction of 6 to 8 mmHg in office systolic blood pressure and 4 to 6 mmHg in HBPM with good adherence to moderate aerobic exercise Integrative practices: 4 mmHg reduction in systolic blood pressure

Secondary Outcome Measures

Name	Time	Method
Body composition	21 months	Indicators: the reduction in fat mass is expected in all intervention groups with an increase in lean muscle mass, especially in groups 2 and 3, which include physical activity. The goal is to achieve a lean mass of over 30% in women and 33% in men.
Body weight	21 months	Indicators: Body weight reduction after 6 months of non-pharmacological intervention Goals: reduction of body weight by 0.9 kg to 1.1 kg each month It is believed that the nutritional intervention and physical activity group has a higher monthly weight loss, reaching up to 2 kg / month.

Trial Locations

Locations (1)

Hospital Universitário Clementino Fraga Filho; 🇧🇷 Rio de Janeiro, Brazil