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

NCT04746118 | Unknown

• 1 other identifier: 41740720.7.1001.5257
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Resistant hypertension; Diet changes; Regular physical activity; Integrative practices; Pre-hypertension

Outcome Measures

Primary Outcomes (1)

• 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

  21 months

Secondary Outcomes (2)

• Body weight

  21 months

• Body composition

  21 months

Other Outcomes (11)

• Glycidic profile

  21 months

• Lipidic profile

  21 months

• Triglycerides

  21 months

Study Arms (4)

CONTROL

NO INTERVENTION

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

DIET CHANGE

EXPERIMENTAL

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.

Behavioral: DIET CHANGE

DIET CHANGE + PHYSICAL ACTIVITY

EXPERIMENTAL

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.

Behavioral: DIET CHANGE; Behavioral: PHYSICAL ACTIVITY

DIET CHANGE + PHYSICAL ACTIVITY + INTEGRATIVE PRACTICES

EXPERIMENTAL

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.

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

Interventions

DIET CHANGE BEHAVIORAL

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.

Also known as: Nutritional intervention

DIET CHANGE; DIET CHANGE + PHYSICAL ACTIVITY; DIET CHANGE + PHYSICAL ACTIVITY + INTEGRATIVE PRACTICES

PHYSICAL ACTIVITY BEHAVIORAL

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.

Also known as: Aerobic training and mobility exercises

DIET CHANGE + PHYSICAL ACTIVITY; DIET CHANGE + PHYSICAL ACTIVITY + INTEGRATIVE PRACTICES

INTEGRATIVE PRACTICES OTHER

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.

Also known as: Holistic Health Integrative practices: mind-fullness meditation and auriculotherapy

DIET CHANGE + PHYSICAL ACTIVITY + INTEGRATIVE PRACTICES

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitário Clementino Fraga Filho: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Hospital Universitário Clementino Fraga Filho

Rio de Janeiro, 21941-913, Brazil

Location

Related Publications (4)

• 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.

  PMID: 30165516 BACKGROUND

• 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.

  PMID: 28446526 BACKGROUND

• 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.

  PMID: 28863392 BACKGROUND

• 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.

  PMID: 30288097 BACKGROUND

MeSH Terms

Conditions

Hypertension; Prehypertension

Interventions

Exercise; Auriculotherapy

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Complementary Therapies; Therapeutics

Study Officials

• Elizabeth S. Muxfeldt, PhD Dr.

  Hospital Universitário Clementino Fraga Filho

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: 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.

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 9, 2021
• Study Start: April 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: April 1, 2023
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)