Evaluation of Effectiveness of Nutritional Counseling in Patients After Stroke

NCT01517542 | Withdrawn DMC

• 1 other identifier: 10-0014
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stroke; Cardiovascular Diseases

Keywords

diet; DASH; Stroke; Nutritional counseling

Outcome Measures

Primary Outcomes (1)

• Change from baseline arterial blood pressure and 6 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.

  30 days and 3, 6, 9 and 12 months

Secondary Outcomes (2)

• Change in lipids from baseline

  30 days, 3, 6, 9 and 12 months

• Change in the body weight

  30 days and 3, 6, 9 and 12 months

Study Arms (2)

Nutritional counseling

EXPERIMENTAL

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

Usual diet

NO INTERVENTION

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

Interventions

Nutritional Counseling OTHER

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

Also known as: adherence, nutrition

Nutritional counseling

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

MeSH Terms

Conditions

Stroke; Cardiovascular Diseases

Interventions

Nutrition Assessment; Nutritional Status

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• Sheila CO Martins, PI

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

• Vanessa A Piper, SI

  Hospital de Clínicas de Porto Alegre

  STUDY DIRECTOR

• Márcia LF Chaves, SI

  Hospital de Clínicas de Porto Alegre

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: November 22, 2011
• First Posted: January 25, 2012
• Study Start: February 1, 2010
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: September 16, 2021

Record last verified: 2021-09