An interventional study of Nutrineal in Thyroid Disease, sponsored by Çanakkale Onsekiz Mart University. Not yet recruiting at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-18.
Sponsored by Çanakkale Onsekiz Mart University · Not applicable, Interventional, and Prevention
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.
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:
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).
365 studies on the registry are indexed under Thyroid Diseases; 80 are open to participants now.
This study's planned enrollment of 60 is below the median of 88 across 198 interventional studies indexed under Thyroid Diseases.
Browse Thyroid Diseases studies →Çanakkale Onsekiz Mart University is the lead sponsor of 51 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
The 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.
Other: Nutrineal
The 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.
The "Education for Thyroid Patients' Nutrition" power point presentation prepared by the researcher will also be done using a computer.
Also known as: Nutrition Education
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.
Time frame: Baseline and after 6 months
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.
Time frame: Baseline and after 6 months
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.
Time frame: Baseline and after 6 months
Plan to share: No
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Çanakkale Onsekiz Mart University