- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06217692
The Effect of Nutrition Education Hemodialysis Patients (Hemodialysis)
January 21, 2024 updated by: Zahide Akeren, Bayburt University
The Effect of Nutrition Education Given to Haemodialysis Patients on Food Consumption and Diet Attitude: A Randomised Controlled Study
type of study: Clinical trial Purpose of the study: The aim of this study was to investigate the effect of nutrition education on dietary attitudes and daily consumption of essential nutrients in patients receiving haemodialysis treatment.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Patients who agree to participate in the study will be included in the experimental group and control group as a result of statistical analysis and the number of patients will be determined.
Then, the patients will be assigned to the groups with the randomisation method of;simple and stratified sampling;.
The experimental and control groups within the scope of the research will be determined by simple randomisation method (coin toss).
In the first interview, the individuals in the training group will be administered the Individual Information Form; and the;Attitude Scale of Hemodialysis Patients towards Diet Therapy as a pre-test by the researcher using the face-to-face interview method.
Then, 24-Hour Food Consumption Record will be given and all food/liquids eaten and drunk for 24 hours retrospectively will be asked to be written on this form.
At this stage, the researchers will help the participants to fill in the food consumption record if needed.
This process will take approximately 20 minutes and the food consumption record will be collected again.
Then, the individuals in the training group will be informed about nutrition education and the first nutrition education will be started.
The training will last for 4 weeks, twice a week, and the length of the training will be forty minutes.
After the last of the trainings, which will last 8 times in total, the Attitude Scale of Hemodialysis Patients towards Diet Therapy will be applied as a post-test using the face-to-face interview method.
In the same way, 24-Hour Food Consumption Record will be given and all food/liquids eaten and drunk for 24 hours retrospectively will be asked to be written on this form.
In the control group, pretest data forms (Individual Information Form and Attitude Scale towards Diet Therapy of Haemodialysis Patients) and three-day 24-Hour Food Consumption Record will be filled out, and the Attitude Scale and three-day 24-Hour Food Consumption Record will be filled out one month later as the posttest.
Study Type
Interventional
Enrollment (Estimated)
40
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
-
-
-
Bayburt, Turkey, 6900
- Bayburt 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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- - Receiving treatment in the haemodialysis unit of Bayburt State Hospital, having contact addresses in electronic media,
- Maintaining haemodialysis treatment for the last 3 months
- No significant psycho-emotional problems,
- It will consist of patients who are not taking any psychotropic medication and who volunteer to participate in the study.
Exclusion Criteria:
- - Reluctance to continue co-operation,
- Moving from the haemodialysis centre to other centres for any reason,
- The emergence of acute and malignant disease,
- The need for transplantation for any reason
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: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control group
|
|
|
Experimental: experimental group
|
nutrition education
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the effect of nutrition education on dietary behaviour.
Time Frame: 4 mounths.
|
the effect of nutrition education on dietary behaviour-Attitude Scale Towards Diet Treatment of Hemodialysis Patients
|
4 mounths.
|
|
Attitude Scale Towards Diet Treatment of Hemodialysis Patients.
Time Frame: 4 mounths.
|
Attitude Scale Towards Diet Treatment of Hemodialysis Patients.
|
4 mounths.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
December 15, 2023
Primary Completion (Estimated)
February 2, 2024
Study Completion (Estimated)
August 2, 2024
Study Registration Dates
First Submitted
December 22, 2023
First Submitted That Met QC Criteria
January 20, 2024
First Posted (Actual)
January 22, 2024
Study Record Updates
Last Update Posted (Actual)
January 23, 2024
Last Update Submitted That Met QC Criteria
January 21, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- Researcher (Other Identifier: Bahçeşehir University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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