- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06208969
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
Status
Completed
Conditions
Intervention / Treatment
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
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-
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.
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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
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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.
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Hospitalization (up to day 5), first month after discharge, third month after discharge
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Malnutrition
Time Frame: Hospitalization (up to day 5), first month after discharge, third month after discharge
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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.
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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
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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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-3.1T/14
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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