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

Primary Purpose

Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
DIET CHANGE
PHYSICAL ACTIVITY
INTEGRATIVE PRACTICES
Sponsored by
Hospital Universitário Clementino Fraga Filho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Resistant hypertension, Diet changes, Regular physical activity, Integrative practices, Pre-hypertension

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital Universitário Clementino Fraga Filho

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

CONTROL

DIET CHANGE

DIET CHANGE + PHYSICAL ACTIVITY

DIET CHANGE + PHYSICAL ACTIVITY + INTEGRATIVE PRACTICES

Arm Description

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

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.

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.

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.

Outcomes

Primary Outcome Measures

Blood pressure
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

Body weight
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.
Body composition
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.

Full Information

First Posted
January 26, 2021
Last Updated
February 4, 2021
Sponsor
Hospital Universitário Clementino Fraga Filho
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT04746118
Brief Title
Diet and Other Non Pharmacological Interventions to Reduce Cardiovascular Risk in Hypertensive Patients
Official Title
Effectiveness of Nutritional Intervention Alone or Associated With Other Non-pharmacological Interventions in Controlling Hypertension and Reducing Cardiovascular Risk - Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 2021 (Anticipated)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitário Clementino Fraga Filho
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Resistant hypertension, Diet changes, Regular physical activity, Integrative practices, Pre-hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Besides the control group (n=60), three other groups with different severity of hypertension will be included in the study. To evaluate strategies adopted as primary prevention 60 pre-hypertensive patients will be recruited. To evaluate blood pressure control and cardiovascular risk reduction, other 60 hypertensives will be also invited to the study. Finally, 60 individuals with resistant hypertension will be recruited to access secondary and tertiary prevention with possible blood pressure control, reduction in the number of drugs in use and subclinical lesions regression.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CONTROL
Arm Type
No Intervention
Arm Description
During routine clinical visits the patients will receive a written standard general guidelines for diet and physical activity.
Arm Title
DIET CHANGE
Arm Type
Experimental
Arm 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.
Arm Title
DIET CHANGE + PHYSICAL ACTIVITY
Arm Type
Experimental
Arm 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.
Arm Title
DIET CHANGE + PHYSICAL ACTIVITY + INTEGRATIVE PRACTICES
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
DIET CHANGE
Other Intervention Name(s)
Nutritional intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
PHYSICAL ACTIVITY
Other Intervention Name(s)
Aerobic training and mobility exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
INTEGRATIVE PRACTICES
Other Intervention Name(s)
Holistic Health Integrative practices: mind-fullness meditation and auriculotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood pressure
Description
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
Time Frame
21 months
Secondary Outcome Measure Information:
Title
Body weight
Description
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.
Time Frame
21 months
Title
Body composition
Description
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.
Time Frame
21 months
Other Pre-specified Outcome Measures:
Title
Glycidic profile
Description
Indicators: laboratory tests - glycated hemoglobin after 6 months of non-pharmacological intervention Goals: Glycated hemoglobin reduction <6,0%
Time Frame
21 months
Title
Lipidic profile
Description
Indicators: laboratory tests - lipogram after 6 months of non-pharmacological intervention Goals: Total cholesterol < 200 mg/d
Time Frame
21 months
Title
Triglycerides
Description
Indicators: laboratory tests - serum triglycerides after 6 months of non-pharmacological intervention Goals: triglycerides < 150 mg/dL
Time Frame
21 months
Title
Left ventricular hypertrophy
Description
Indicators: ECG voltage indices (left ventricular hypertrophy) reduction after 6 months of non-pharmacological intervention. Goals: Reduction of Sokolow-Lyon index (SV1 + RV5)
Time Frame
21 months
Title
Renal function
Description
Indicators: glomerular filtration rate (GFR) after 6 months of non-pharmacological intervention Goals: Increase GFR > 60 ml/min/m2 body surface area (BSA)
Time Frame
21 months
Title
Albuminuria
Description
Indicators: albuminuria in urinary spot Goals: Reduction of Albuminuria < 30mg/g creatinine
Time Frame
21 months
Title
Aortic stiffness
Description
Indicators: pulse wave velocity (PWV) measurement (aortic stiffness) Goals: reduction of aortic stiffness measured by PWV < 10 m/s
Time Frame
21 months
Title
Endothelial dysfunction
Description
Indicators: Laser Doppler flowmetry (microvascular reactivity reflects endothelial dysfunction) Goals: increase microvascular reactivity with a percentage > 10%
Time Frame
21 months
Title
Improved quality of life
Description
Indicators: scores obtained in the World Health Organization Quality of Life questionnaire (WHOQOL-Bref) Goals: Improvement of the 4 domains investigated in the WHOQOL-Bref: physical health, psychological, social relationships and environment. Results in % varies from 0 to 100. The higher the percentage (closer to 100%) the better the quality of life.
Time Frame
21 months
Title
Obstructive Sleep Apnea (OSA) risk
Description
Indicators: scores obtained in the Stop-Bang (Snoring, Tiredness, Observed apnea, high blood Pressure, Body mass index, Age, Neck circumference, and Gender) questionnaires indicate high risk for OSA:- STOP-BANG score > 3 Goals: Reduce the STOP-BANG score to <3
Time Frame
21 months
Title
Excessive daytime sleepiness
Description
Indicators: scores obtained in the Epworth Sleepiness Scale (ESS) indicate excessive sleepiness and possible high risk for OSA: (ESS > 10.) Goals: Reduce the ESS score to <10.
Time Frame
21 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth S. Muxfeldt, PhD Dr.
Organizational Affiliation
Hospital Universitário Clementino Fraga Filho
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitário Clementino Fraga Filho
City
Rio de Janeiro
ZIP/Postal Code
21941-913
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabeth S. Muxfeldt, Dr. PhD
Phone
55-21-3938-2789
Email
prohart.hucff@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30165516
Citation
Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, Clement DL, Coca A, de Simone G, Dominiczak A, Kahan T, Mahfoud F, Redon J, Ruilope L, Zanchetti A, Kerins M, Kjeldsen SE, Kreutz R, Laurent S, Lip GYH, McManus R, Narkiewicz K, Ruschitzka F, Schmieder RE, Shlyakhto E, Tsioufis C, Aboyans V, Desormais I; ESC Scientific Document Group. 2018 ESC/ESH Guidelines for the management of arterial hypertension. Eur Heart J. 2018 Sep 1;39(33):3021-3104. doi: 10.1093/eurheartj/ehy339. No abstract available. Erratum In: Eur Heart J. 2019 Feb 1;40(5):475.
Results Reference
background
PubMed Identifier
28446526
Citation
Schwingshackl L, Chaimani A, Hoffmann G, Schwedhelm C, Boeing H. Impact of different dietary approaches on blood pressure in hypertensive and prehypertensive patients: protocol for a systematic review and network meta-analysis. BMJ Open. 2017 Apr 26;7(4):e014736. doi: 10.1136/bmjopen-2016-014736.
Results Reference
background
PubMed Identifier
28863392
Citation
Pascoe MC, Thompson DR, Jenkins ZM, Ski CF. Mindfulness mediates the physiological markers of stress: Systematic review and meta-analysis. J Psychiatr Res. 2017 Dec;95:156-178. doi: 10.1016/j.jpsychires.2017.08.004. Epub 2017 Aug 23.
Results Reference
background
PubMed Identifier
30288097
Citation
Lopes S, Mesquita-Bastos J, Alves AJ, Ribeiro F. Exercise as a tool for hypertension and resistant hypertension management: current insights. Integr Blood Press Control. 2018 Sep 20;11:65-71. doi: 10.2147/IBPC.S136028. eCollection 2018.
Results Reference
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Diet and Other Non Pharmacological Interventions to Reduce Cardiovascular Risk in Hypertensive Patients

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