Evaluation of Effectiveness of Nutritional Counseling in Patients After Stroke

Sponsor

Hospital de Clinicas de Porto Alegre (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01517542

Collaborator

(none)

Enrollment

Arms

139

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Cardiovascular Diseases	Other: Nutritional Counseling	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Evaluation on the Effectiveness of Nutritional Counseling on an Adapted DASH Diet in Patients After Stroke: a Randomized Clinical Trial

Actual Study Start Date :

Feb 1, 2010

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Sep 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: Nutritional Counseling 2 groups: 1 with nutritional counseling and other with usual diet without nutritional counseling Other Names: adherence nutrition
No Intervention: Usual diet It was composed by patients who were stimulated to follow the general orientations of the neurologist or keep their food intake habits

Arm

Intervention/Treatment

Experimental: 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.

Other: Nutritional Counseling

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

Other Names:

adherence

nutrition

No Intervention: Usual diet

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

Outcome Measures

Primary Outcome Measures

Change from baseline arterial blood pressure and 6 months [30 days and 3, 6, 9 and 12 months]
The patients will be randomized to one of the 2 groups (with nutritional counseling and no intervention - habitual diet). The main endpoint will be the change in the blood pressure values and adherence to treatment measured in 30 days and 3, 6, 9 and 12 months.

Secondary Outcome Measures

Change in lipids from baseline [30 days, 3, 6, 9 and 12 months]
The patients will be randomized to one of the 2 groups (with nutritional counseling and no intervention - habitual diet). The secundary endpoint will be the change in the lipid profile and adherence to treatment measured in 30 days and 3, 6, 9 and 12 months.
Change in the body weight [30 days and 3, 6, 9 and 12 months]
The patients will be randomized to one of the 2 groups (with nutritional counseling and no intervention - habitual diet). The secundary endpoint will be the change in the body weight measured in 30 days and 3, 6, 9 and 12 months.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Ischemic Stroke up to 3 months
Modified Rankin Score < 4

Exclusion Criteria:

Aphasia
Enteral diet
Unavailability to follow up the study

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Hospital de Clinicas de Porto Alegre

Investigators

Principal Investigator: Sheila CO Martins, PI, Hospital de Clínicas de Porto Alegre
Study Director: Vanessa A Piper, SI, Hospital de Clínicas de Porto Alegre
Study Chair: Márcia LF Chaves, SI, Hospital de Clínicas de Porto Alegre