NCT07027579

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 18, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

July 20, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

June 18, 2025

Status Verified

June 1, 2025

Enrollment Period

2 months

First QC Date

June 11, 2025

Last Update Submit

June 11, 2025

Conditions

Keywords

Thyroid DysfunctionQuality of LifeChronic Disease AdaptationNutrition Education Program

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Baseline and after 6 months

Study Arms (2)

Intervetion group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

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
Intervetion group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Çanakkale Onsekiz Mart University, Faculty of Health Sciences

Çanakkale, 17100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Thyroid Diseases

Interventions

NutrinealNutrition Assessment

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • NAİLE ALANKAYA, Assoc. Prof

    Çanakkale Onsekiz Mart University, Faculty of Health Sciences

    STUDY DIRECTOR

Central Study Contacts

Naile Alankaya, Assoc.Prof

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof

Study Record Dates

First Submitted

June 11, 2025

First Posted

June 18, 2025

Study Start

July 20, 2025

Primary Completion

September 15, 2025

Study Completion

December 30, 2025

Last Updated

June 18, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations