The Effect of Nutrition Counseling on Nutritional Status in Stroke Patients

January 6, 2024 updated by: Dilek Seyidoglu Yuksel, Ege University

Comparison of Intensive and Standard Nutrition Counseling in Monitoring the Nutritional Status of Stroke Patients

The purpose of this study is to investigate the effect of intensive nutrition counseling on nutritional status and functional recovery in stroke patients over the age of 65, compared to standard nutrition counseling.

Study Overview

Detailed Description

Stroke is the second most common cause of death in the world; It is the third cause of disability that causes serious loss of function and affects patients' daily activities. The rapid aging of society increases the negative impact of stroke on health and limited health resources. 9-35% of patients hospitalized with the diagnosis of acute stroke have malnutrition. However, in the first two weeks after hospitalization, malnutrition rates approximately double within two weeks of hospitalization. Although nutrition is a physiological need, it is also a social activity. Nutritional practices that meet nutritional needs during the disease process may contribute to the functional recovery of patients, the reduction of complications, and survival, as well as contributing to the quality of life of patients, independent of the disease. In terms of malnutrition risk, monitoring and treatment are recommended during the acute and discharge periods. There is a need for studies on the framework and effects of effective nutritional treatment. In order for nutrition treatment practices after discharge to achieve their goals, caregivers need to be trained effectively on this subject. Therefore, the aim of this study is to examine the effects of intensive nutrition counseling to stroke patients over the age of 65 on nutritional and functional status.

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • İzmir, Turkey
        • Ege University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being admitted to Ege University Faculty of Medicine Hospital Neurology Intensive Care or Clinic with the diagnosis of acute stroke
  • The patient agrees to participate in the study
  • Hospital stay for more than 3 days

Exclusion Criteria:

  • Active malignancy, dementia, terminal illness, tetraplegia, severe metabolic disorder
  • Failure to obtain written consent indicating that they agreed to participate in the study.
  • The patient did not come for a check-up during the 3-month follow-up period
  • The patient's stay is longer than 30 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intensive nutrition counseling
Five-stage nutrition counseling vith educational materials was carried out during hospitalization in the intensive nutrition counseling. Telephone interviews were conducted at the 2nd week and 2nd month after discharge.
individualized regular nutrition education
Active Comparator: standard nutrition counseling
Routine nutritional counseling was applied. Interviewed only at admission and at discharge if patient is consulted.
individualized regular nutrition education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Malnutrition Risk
Time Frame: Hospitalization (up to day 5), first month after discharge, third month after discharge
Malnutrition risk status according to MUST
Hospitalization (up to day 5), first month after discharge, third month after discharge
BMI
Time Frame: Hospitalization (up to day 5), first month after discharge, third month after discharge
Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters. If BMI<22 kg/m2, it is considered low
Hospitalization (up to day 5), first month after discharge, third month after discharge
Calf Circumference Measurement
Time Frame: Hospitalization (up to day 5), first month after discharge, third month after discharge
The widest part of the calf was measured from the non-paralyzed side in a sitting position with 90 degrees.
Hospitalization (up to day 5), first month after discharge, third month after discharge
Malnutrition
Time Frame: Hospitalization (up to day 5), first month after discharge, third month after discharge
Malnutrition diagnosis according to GLIM criteria
Hospitalization (up to day 5), first month after discharge, third month after discharge
Mid Upper Arm Circumference
Time Frame: Hospitalization (up to day 5), first month after discharge, third month after discharge
Mid upper arm circumference is measured at the midpoint between the acromion and olecranon processes on the shoulder blade and the ulna.
Hospitalization (up to day 5), first month after discharge, third month after discharge
Mid Upper Arm Muscle Area
Time Frame: Hospitalization (up to day 5), first month after discharge, third month after discharge
Mid upper arm muscle area is calculated using the standard formula= Mid Upper Arm Circumference-(3.14 x Triceps skinfold thickness)
Hospitalization (up to day 5), first month after discharge, third month after discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Status
Time Frame: last day of hospitalization, first month after discharge, third month after discharge
Functional status was evaluated according to the Barthel Activities of Daily Living İndex
last day of hospitalization, first month after discharge, third month after discharge
Disability
Time Frame: last day of hospitalization, first month after discharge, third month after discharge
Disability was evaluated according to The Modified Rankin Scale
last day of hospitalization, first month after discharge, third month after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Sevnaz Sahin, Assoc Prof, Ege University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2021

Primary Completion (Actual)

May 4, 2022

Study Completion (Actual)

November 15, 2023

Study Registration Dates

First Submitted

December 2, 2023

First Submitted That Met QC Criteria

January 6, 2024

First Posted (Actual)

January 17, 2024

Study Record Updates

Last Update Posted (Actual)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 6, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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