Evaluation of Effectiveness of Nutritional Counseling in Patients After Stroke

NCT ID: NCT01517542

Last Updated: 2021-09-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2021-09-30

Brief Summary

Stroke is the leading cause of disability worldwide and the leading cause of death in Brazil. It is estimated that about 18 million people will have a stroke in 2015 and approximately one third of these resulting in death. The factors most important modifiable risk for stroke include high blood pressure (hypertension), diabetes, smoking, dyslipidemia, sedentary lifestyle and obesity. Acting on these risk factors can be reduced by 88% the risk of another stroke. Healthy eating is among the changes in lifestyle that are recommended for prevention and treatment of one of the main risk factors for stroke. Studies show that the adoption of the DASH diet can significantly reduce blood pressure and the result is even more significant in hypertensive patients, making this diet a new alternative in the prevention and treatment of hypertension and consequently stroke. Compliance therapy is a determining factor for success in the treatment of chronic diseases. Adherence to long-term treatment in developed countries is around 50% and in developing countries the rates are even lower. The aim of this study is to evaluate the effectiveness of nutritional counseling in an adapted DASH style diet on body weight, glycemic control, blood pressure values and improved lipid profile compared to the usual diet without nutritional counseling in patients with stroke within the last 3 months. The hypothesis is that nutritional counseling with an adapted DASH style diet reduces cardiovascular risk factors compared with the usual diet without nutritional counseling in patients with stroke within 3 months. The stroke patients will be selected in the hospitalization or in the outpatient clinic of Hospital de Clínicas de Porto Alegre in a period up to 3 months after ischemic stroke. The patients will be randomized to one of the 2 groups. In the first visit they will be submitted to a social class and international physical activity questionnaire and they will be submitted to a food frequency questionnaire, measures of weight, height, waist circumference, hip and neck, blood pressure and cholesterol and glucose measurements at the baseline, 30 days and 3, 6, 9 and 12 months. The main endpoints will be the change in the body weight, blood glucose, blood pressure values and lipid profile.

Detailed Description

The study will be followed by a evaluation of other endpoints: new stroke, myocardial infarction or cardiovascular death.

Conditions

Stroke; Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Nutritional counseling

It was composed by patients who received specific written orientation to follow the DASH diet recommendations. Calories were calculated with the goal of maintaining body weight and divided into 3 main meals and two to three snacks.

Group Type: EXPERIMENTAL

Nutritional Counseling

Intervention Type: OTHER

2 groups: 1 with nutritional counseling and other with usual diet without nutritional counseling

Usual diet

It was composed by patients who were stimulated to follow the general orientations of the neurologist or keep their food intake habits

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nutritional Counseling

2 groups: 1 with nutritional counseling and other with usual diet without nutritional counseling

Intervention Type: OTHER

Other Intervention Names

adherence; nutrition

Eligibility Criteria

Inclusion Criteria

• Ischemic Stroke up to 3 months
• Modified Rankin Score < 4

Exclusion Criteria

• Aphasia
• Enteral diet
• Unavailability to follow up the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

SHEILA CRISTINA OURIQUES MARTINS

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sheila CO Martins, PI

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clínicas de Porto Alegre

Vanessa A Piper, SI

Role: STUDY_DIRECTOR

Hospital de Clínicas de Porto Alegre

Márcia LF Chaves, SI

Role: STUDY_CHAIR

Hospital de Clínicas de Porto Alegre

Other Identifiers

10-0014

Identifier Type: -

Identifier Source: org_study_id