Haemodialysis PatientsHemodialysisNCT06217692
The Effect of Nutrition Education Hemodialysis Patients
A study testing nutrition education in people with Haemodialysis Patients, run by Bayburt University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Haemodialysis Patients
- What is being tested?
- nutrition education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2023to 2 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - 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.
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Haemodialysis Patients
- Being tested
- nutrition education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutrition educationOther
nutrition education
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | experimental group Receives: Other: nutrition education |
| control group | No intervention | control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effect of nutrition education on dietary behaviour.
the effect of nutrition education on dietary behaviour-Attitude Scale Towards Diet Treatment of Hemodialysis Patients
Measured: 4 mounths.
Attitude Scale Towards Diet Treatment of Hemodialysis Patients.
Attitude Scale Towards Diet Treatment of Hemodialysis Patients.
Measured: 4 mounths.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start15 Dec 2023
- Primary completion2 Feb 2024 (estimated)
- Study completion2 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Haemodialysis PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayburt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahide Akeren, Bayburt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06217692
- Sponsor's protocol ID
- Researcher
- Other IDs
- Researcher
- Acronym
- Hemodialysis
- Status last verified
- Jan 2024
- First submitted
- 22 Dec 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akeren Z, Cakmak VS, Kalyoncuo S. The effect of dietary education on attitudes and behaviors in hemodialysis patients: A randomized trial. Contemp Clin Trials. 2025 Sep;156:108011. doi: 10.1016/j.cct.2025.108011. Epub 2025 Jul 13.
PubMed 40664299
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nutrition Education Given to Haemodialysis Patients on Food Consumption and Diet Attitude: A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT06217692
- Acronym / sponsor ID
- Hemodialysis / Researcher
- Conditions
- Haemodialysis Patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bayburt UniversityUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 2 Feb 2024 (estimated)
- Study completion
- 2 Aug 2024 (estimated)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: nutrition educationexperimental group |
| control group | No intervention | –control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- - 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.
Key exclusion criteria (4 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nutrition educationnutrition education | Other | experimental group |
Primary outcome
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
Attitude Scale Towards Diet Treatment of Hemodialysis Patients.
Time frame: 4 mounths.
Attitude Scale Towards Diet Treatment of Hemodialysis Patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Derived from this study: PubMed 40664299Akeren Z, Cakmak VS, Kalyoncuo S. The effect of dietary education on attitudes and behaviors in hemodialysis patients: A randomized trial. Contemp Clin Trials. 2025 Sep;156:108011. doi: 10.1016/j.cct.2025.108011. Epub 2025 Jul 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nutrition education in people with Haemodialysis Patients, run by Bayburt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the effect of nutrition education on dietary behaviour. (time frame: 4 mounths.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06217692, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.