Evaluation of the Effect of Animated Video-Assisted Nutrition Education on Heart Failure Patients

January 18, 2026 updated by: Yasemin BOY, Tokat Gaziosmanpasa University

Evaluation of the Effect of Animated Video-Assisted Nutrition Education on Nutritional Behaviors, Symptom Severity, and Quality of Life in Heart Failure Patients

This randomized controlled trial aims to evaluate the effect of animation video-supported nutrition education on dietary behaviors, symptom severity, and quality of life in patients with heart failure. A total of 70 patients aged 45-60 years with NYHA class II or III heart failure will be recruited at Tokat Gaziosmanpaşa University Research and Application Hospital Cardiology Clinic. Participants will be randomly assigned to an intervention group, which will receive video-supported nutrition education, or a control group, which will receive standard care. Outcomes will be assessed using the Heart Failure Dietary Behavior Scale, Heart Failure Symptom Status Scale, and Minnesota Living with Heart Failure Questionnaire at baseline, 1 month, 3 months, and 6 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study investigates the effect of animation video-supported nutrition education on dietary behaviors, symptom severity, and quality of life in patients with heart failure (HF). The study will be conducted at Tokat Gaziosmanpaşa University Research and Application Hospital Cardiology Clinic from July 2025 to December 2025. A total of 70 patients aged 45-60 years with NYHA class II or III HF will be included. Patients meeting the inclusion criteria and willing to participate will be randomly assigned to the intervention or control group using a computer-based simple randomization method.

The intervention group will receive a structured nutrition education program delivered through animation videos developed based on clinical guidelines, focusing on balanced nutrition, sodium restriction, sugar and cholesterol control, and fluid retention prevention. Videos will illustrate key concepts using the "5W1H and Symptom" (What, Where, How, When, Why, Symptom) principle. Baseline assessments will include the Heart Failure Dietary Behavior Scale, Heart Failure Symptom Status Scale, Minnesota Living with Heart Failure Questionnaire, and a demographic form. Follow-up assessments will be conducted at 1 month, 3 months, and 6 months.

The control group will receive standard care, including verbal advice from cardiologists. After completion of the study, control group patients will also have access to the animation video education. Data will be analyzed using SPSS v25 with appropriate statistical tests, and linear mixed-effects models will be applied to evaluate group, time, and group-time interaction effects.

Study Type

Interventional

Enrollment (Actual)

70

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

  • Turkey (Türkiye)
    • Tokat Province
      • Tokat Province, Tokat Province, Turkey (Türkiye), 60100
        • Tokat Gaziosmanpaşa 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:

Individuals who have been diagnosed with heart failure at least six months ago,

  • Are between the ages of 45-60,
  • Are in NYHA stage II or III,
  • Have a mobile phone capable of watching videos,
  • Volunteer to participate in the study will be included in the study.

Exclusion Criteria:

Individuals with HF who were included in the study as a sample,

  • Patients with fluid restriction under a different protocol (e.g., Chronic Renal Failure),
  • Patients with chronic pulmonary disease (e.g., COPD),
  • Illiterate,
  • Do not own a mobile phone capable of watching videos,
  • Have physical or cognitive impairments,
  • Have a psychiatric illness,
  • Refuse to participate in the study will not be included in the study.
  • Patients hospitalized during the study period will be excluded from the study, and their data will not be subject to statistical analysis.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Patients will receive animation video-supported nutrition education focusing on balanced diet, sodium restriction, sugar and cholesterol control, and fluid retention prevention. Videos will follow the "5W1H and Symptom" principle. Follow-ups will be at 1 month, 3 months, and 6 months using HF Dietary Behavior Scale, HF Symptom Status Scale, and Minnesota Living with HF Questionnaire.
Behavioral: Animation Video-Supported Nutrition Education
Structured education using animation videos on balanced diet, sodium restriction, sugar/cholesterol control, fluid retention prevention. Videos delivered in hospital and accessible on patients' phones for 6 months with weekly reminders.
No Intervention: Control Group
Patients will receive standard care (verbal advice from cardiologists) and will complete the same assessments at baseline, 1 month, 3 months, and 6 months. After study completion, they will also receive access to the animation video education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Score on the Heart Failure Dietary Behavior Scale
Time Frame: At baseline, 1 month, 3 months, and 6 months
Dietary behaviors will be evaluated using the Heart Failure Dietary Behavior Scale, developed by Boy and Enç (2022). The scale consists of 19 items across four subscales: Healthy Habits, Salt Restriction, Sugar Restriction, and Prevention of Fluid Retention. Items are rated on a 4-point Likert scale, yielding a total score range of 19-76. Higher scores indicate better adherence to dietary recommendations. A cutoff score of 46 is used; scores ≥46 indicate adherence to guideline-recommended nutritional behaviors.
At baseline, 1 month, 3 months, and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Score on the Heart Failure Symptom Status Scale (Symptom Severity)
Time Frame: At baseline, 1 month, 3 months, and 6 months
Symptom severity will be assessed using the Heart Failure Symptom Status Scale, developed by Heo et al. (2015). This patient-reported outcome measure evaluates the presence, frequency, severity, and degree of distress associated with seven common heart failure symptoms: daytime dyspnea, orthopnea, fatigue, chest pain, edema, sleep problems, and dizziness or lightheadedness. Each symptom is rated using 4-point Likert-type response options. A response of "0" indicates absence of the symptom. When a symptom is present, patients rate symptom frequency (1 = less than once per week to 4 = nearly every day), severity (1 = mild to 4 = very severe), and symptom-related distress (1 = almost none to 4 = very much). Scores for each symptom are calculated by summing frequency, severity, and distress ratings. Total scores range from 0 to 84, with higher scores indicating greater symptom severity.
At baseline, 1 month, 3 months, and 6 months
Mean Score on the Minnesota Living with Heart Failure Questionnaire (Quality of Life)
Time Frame: At baseline, 1 month, 3 months, and 6 months
Quality of life will be assessed using the Minnesota Living with Heart Failure Questionnaire, developed by Rector et al. (1992). The questionnaire consists of 21 items evaluating the impact of heart failure on patients' physical, emotional, and social functioning, including symptoms such as dyspnea, peripheral edema, fatigue, anxiety, and depressive symptoms. Eight items assess the physical dimension (score range: 0-40), and five items assess the emotional dimension (score range: 0-25); the remaining items contribute to the total score only. Each item is scored on a 6-point Likert scale ranging from 0 ("no impact") to 5 ("very much"). Total scores range from 0 to 105, with lower scores indicating better quality of life.
At baseline, 1 month, 3 months, and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tokat Gaziosmanpasa University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 16, 2025

Primary Completion (Actual)

December 1, 2025

Study Completion (Actual)

December 30, 2025

Study Registration Dates

First Submitted

November 15, 2025

First Submitted That Met QC Criteria

December 12, 2025

First Posted (Actual)

December 26, 2025

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 18, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOU-2025-RCT-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data that underlie the results reported in the primary and secondary outcome analyses, including outcome measure scores and relevant baseline characteristics.

IPD Sharing Time Frame

Beginning after publication of the primary results and available upon reasonable request.

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal and agree to the terms of a data use agreement. Requests will be reviewed by the principal investigator. Access will be provided for academic, non-commercial research purposes only.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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