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Thyroid DiseaseNCT07027579

Effect of Nutrition Education on the Quality of Life, Chronic Disease Adaptation in Patients With Thyroid Dysfunction

A study testing Nutrineal in people with Thyroid Disease, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This thesis study is designed to examine the effects of nutrition education provided to individuals with thyroid dysfunction on their quality of life and adaptation to the disease. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thyroid Disease
What is being tested?
Nutrineal
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Jul 2025to 30 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Not having any physical or mental disabilities
  • Not having received such training before
  • Volunteering to participate in the study
  • Be 18 years of age or older.

Who cannot join

  • Being under 18 years of age.
  • Having cognitive dysfunction.
  • Not volunteering to participate in the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Naile Alankaya, Assoc.Prof contact

+905334256510

nailealankaya@comu.edu.tr

Turkey (Türkiye)1 site
  • Çanakkale Onsekiz Mart University, Faculty of Health Sciences

    Çanakkale, 17100

    nailealankaya@comu.edu.tr

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Nutrition Education Program on the Quality of Life and Chronic Disease Adaptation in Patients With Thyroid Dysfunction

This thesis study is designed to examine the effects of nutrition education provided to individuals with thyroid dysfunction on their quality of life and adaptation to the disease. The data will be collected using the Descriptive Characteristics Form, the Nutrition Attitude Scale, the Quality of Life Scale for Thyroid Patients (ThyPRO), and the Chronic Illness Adherence Scale. The Body Mass Index (BMI) of participating patients will be calculated by the researcher based on measured height and weight. Laboratory values including TSH, free T4, and free T3 will be obtained from the patients' medical records on the day of assessment. Data collection will be conducted in two phases. The study population will consist of all patients diagnosed with thyroid dysfunction who present to Dr. Burhan Nalbantoğlu Hospital. Using the G*Power 3.1.9.2 software, the required sample size was calculated prior to data collection with a 95% confidence level. For correlation analysis, an alpha value of 0.05, an effect size of 0.455, and a statistical power of 95% were assumed, resulting in a minimum sample size of 56 participants (30 per group). Accounting for potential data loss, a total of 60 patients (30 per group) are planned to be included in the sample.

Read the detailed description

This thesis study is designed to examine the effects of nutrition education provided to individuals with thyroid dysfunction on their quality of life and adaptation to the disease. Patients with thyroid disorders are affected both physically and socially due to hormonal imbalances. In this context, the study aims to investigate how dietary habits are shaped and how these habits influence individuals' overall quality of life. Accordingly, the following research questions were addressed:

  • Does the nutrition education provided affect the level of nutritional knowledge in patients with thyroid dysfunction?
  • Does the nutrition education provided improve the quality of life in patients with thyroid dysfunction?
  • Does the nutrition education provided enhance disease adaptation in patients with thyroid dysfunction? Implementation of the Study Prior to the nutrition education, patients will be informed about the purpose of the study, the data collection methods, and the content of the educational topics. Patients who agree to participate in the study will be asked to sign an informed consent form. The Body Mass Index (BMI) of participating patients will be calculated by the researcher based on measured height and weight. Laboratory values including TSH, free T4, and free T3 will be obtained from the patients' medical records on the day of assessment. Data collection will be conducted in two phases.

Phase 1:

All patients who agree to participate in the study (both intervention and control groups) will first be asked to complete the "Descriptive Characteristics Form," the "Nutrition Attitude Scale" to assess their dietary habits, the "ThyPRO Questionnaire" to evaluate thyroid-related quality of life, and the "Chronic Illness Adherence Scale (CIAS)" to assess disease adaptation.

The Body Mass Index (BMI) of each participant will be calculated by the researcher through direct measurement of height and weight. Free T4 and free T3 values will be obtained from the patients' medical records on the day of evaluation.

Participants in the intervention group, selected through randomization, will receive a one-on-one, face-to-face educational session in the outpatient clinic's education room. The session will be conducted by the researcher using a PowerPoint presentation titled "Nutrition Education for Thyroid Patients," prepared specifically for the study and delivered via computer. At the end of the session, participants will also be provided with a printed "Nutrition Guide for Thyroid Patients." Participants in the control group will not receive the educational session at this stage; however, they will be given the same printed "Nutrition Guide for Thyroid Patients" prepared by the researcher. It will be communicated to the control group that the same individual training session will be offered to them after the study concludes.

The education will be delivered as a single session, with an expected duration of approximately 30-35 minutes. Following the training, the "Nutrition Attitude Scale" will be re-administered to reassess participants' knowledge levels.

Phase 2:

Three months after the initial planned education session, participants will again complete the "Nutrition Attitude Scale" to assess changes in dietary habits, as well as the "ThyPRO Questionnaire" and the "Chronic Illness Adherence Scale (CIAS)" to evaluate changes in thyroid-related quality of life and disease adaptation. If available, free T4 and free T3 values will be obtained from hospital records on the day of follow-up, and BMI will be recalculated by the researcher.

Participants in the control group will also be asked to complete the same forms three months after the initial assessment. Following the completion of the data collection process, the same one-on-one education provided to the intervention group will be delivered to the control group to eliminate any disadvantage or ethical concerns.

Data Collection Tools:

The data will be collected using the Descriptive Characteristics Form, the Nutrition Attitude Scale, the Quality of Life Scale for Thyroid Patients (ThyPRO), and the Chronic Illness Adherence Scale.

The study population will consist of all patients diagnosed with thyroid dysfunction who present to Dr. Burhan Nalbantoğlu Hospital. Using the G*Power 3.1.9.2 software, the required sample size was calculated prior to data collection with a 95% confidence level. For correlation analysis, an alpha value of 0.05, an effect size of 0.455, and a statistical power of 95% were assumed, resulting in a minimum sample size of 56 participants (30 per group). Accounting for potential data loss, a total of 60 patients (30 per group) are planned to be included in the sample.

Data Analysis The data obtained in the study will be analyzed using SPSS software (Windows version 25.0). Descriptive statistical methods such as frequency, percentage, minimum-maximum values, median, mean, and standard deviation will be used for data evaluation. The normality of the data for the scales used will be assessed through tests of skewness and kurtosis. For normally distributed quantitative data, comparisons between two independent groups will be performed using the independent samples t-test, while comparisons among more than two groups will be conducted using one-way analysis of variance (ANOVA).

Conditions
Thyroid Disease
Being tested
Nutrineal
Keywords
Thyroid Dysfunction, Quality of Life, Chronic Disease Adaptation, Nutrition Education Program
Medical subject headings
Thyroid Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NutrinealOther

    Also called Nutrition Education

    The "Education for Thyroid Patients' Nutrition" power point presentation prepared by the researcher will also be done using a computer.

Study groups in NCT07027579
Study groupRoleWhat they receive
Intervetion groupExperimentalThe intervention group will consist of 30 people. Participants in the experimental group selected by appointment will receive a one-on-one face-to-face outpatient clinic training room with a power point presentation prepared by the researcher on "Nutrition for Thyroid Patients" and a computer. At the end of the training, a "Nutrition for Thyroid Patients" training booklet will also be given.The education will be delivered as a single session, with an expected duration of approximately 30-35 minutes. Following the training, the Nutrition Attitude Scale, Chronic Illness Adherence Scale (CIAS) and Quality of Life Scale for Thyroid Patients (ThyPRO) will be re-administered to reassess participants' knowledge levels.
Receives: Other: Nutrineal
Control groupNo interventionThe control group will consist of 30 people. All patients will be asked to complete the Nutrition Attitude Scale, Quality of Life Scale for Thyroid Patients (ThyPRO) and Chronic Illness Adherence Scale (CIAS). Patients in the control group will not receive any training. The same forms will be filled out for the final test 3 months later. Patients who wish to will be given the training provided in the experimental group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of Life Scale for Thyroid Patients (ThyPRO)

    The "Thyroid-Related Quality of Life Questionnaire - ThyPRO" consists of 12 items. The 12th question stands alone and is analyzed separately. The scale does not yield a total score; instead, each subscale is scored individually on a scale ranging from 0 to 100. Higher scores indicate lower quality of life.

    Measured: Baseline and after 6 months

  2. Nutrition Attitude Scale

    The Nutrition Attitude Scale (NAS) is a five-point Likert-type scale rated from "Strongly agree" (5) to "Strongly disagree" (1). The scale consists of 21 items in total-20 positive and 1 negative. The lowest 21 points and the highest 105 points can be obtained from the nutrition attitude scale. Higher scores from the scale; It will reveal that the individuals who filled the scale have a high attitude towards nutrition and those who have low scores have a low attitude towards nutrition. It can be asserted that individuals' high attitude scores towards nutrition are sensitive to weight control and health.

    Measured: Baseline and after 6 months

  3. Chronic Illness Adaptation Scale (CIAS)

    The scale consists of 25 items across three sub-dimensions: physical adaptation, social adaptation, and psychological adaptation.The total possible score on the scale is 125. Higher scores on the sub-dimensions and/or the total scale indicate a greater level of adaptation to the disease.

    Measured: Baseline and after 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2025
  2. Study start20 Jul 2025 (estimated)
  3. Primary completion15 Sep 2025 (estimated)
  4. Study completion30 Dec 2025 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07027579
Sponsor's protocol ID
COMU-SBF-NA-03
Status last verified
Jun 2025
First submitted
11 Jun 2025
Last updated
18 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Nutrineal in people with Thyroid Disease, run by Çanakkale Onsekiz Mart 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 3 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: opening soon, as of the sponsor's last update on 18 Jun 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Naile Alankaya, Assoc.Prof (+905334256510, nailealankaya@comu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Life Scale for Thyroid Patients (ThyPRO) (time frame: Baseline and after 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 18 Jun 2025.

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