- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07289425
Effect of a Mobile App for Obese Children on Eating Attitudes, Eating Awareness, and Healthy Eating Self-Efficacy
The Effect of a Mobile Application Developed for Obese Children on Eating Attitudes, Eating Awareness, and Healthy Eating Self-Efficacy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study aims to evaluate the effect of a mobile application developed for obese children on their eating attitudes, eating awareness levels, and self-efficacy regarding healthy eating, with the aim of contributing to the integration of nursing interventions with digital health technologies in the fight against obesity. Increasing childhood obesity negatively affects not only physical health but also psychosocial development, necessitating multifaceted and sustainable interventions. In line with nurses' effective roles in health education and behaviour change, the application will be developed to support children in acquiring and maintaining healthy eating habits. Additionally, the integration of digital technologies into nursing care and their effectiveness in reaching families will be evaluated; this study will provide a unique contribution to this area, which is lacking in the literature.
The research data will be collected using the Information Form created by the researcher, the Healthy Eating Self-Efficacy Scale for Children, the Eating Attitude Test for Children, and the Eating Awareness Scale for Children.
A total of 18 questions comprising demographic characteristics of children and parents and their eating habits will be used to collect data for the study. In addition, the Eating Attitude Test, consisting of 26 items, will be used to assess eating behaviour and the risk of possible eating disorders in children aged 8-15 years. the 12-item Eating Awareness Scale to determine the degree to which children aged 8-11 are mindful or automatic while eating, and the 9-item Healthy Eating Self-Efficacy Scale to assess the perceived competence of children aged 8-10 in healthy eating. All forms and scales will be completed by children and parents.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nurcan Karamercimek, Graduate Student
- Phone Number: +90 346 487 37 31
- Email: nurcankaramercimek@gmail.com
Study Locations
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Merkez
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Sivas, Merkez, Turkey (Türkiye), 0058
- Sivas Cumhuriyet University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- The child must be between 8 and 10 years old,
- The child must not have any chronic illnesses other than obesity,
- The child must be able to read and write in Turkish,
- The child must be able to use a mobile device,
- The child must not have a visual impairment,
- The parent must be willing to participate in the study,
- The parent must be able to read and write in Turkish,
- The parent or child must have a smartphone.
Exclusion Criteria:
- If they wish to withdraw from the study at any stage of the research,
- If they do not wish to use the mobile application at any stage of the research.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control group
Preliminary information will be provided and consent will be obtained.
The introductory information form, the eating attitude test for children, the eating awareness scale, and the healthy eating self-efficacy scale will be completed, and BMI calculations will be performed.
These procedures will be repeated during the interim follow-up at the end of the first month and the final test at the end of the second month.
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|
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Experimental: working group
Preliminary information will be provided and consent will be obtained.
An introductory information form, a food attitude test for children, a food awareness scale, and a healthy eating self-efficacy scale will be completed, and BMI calculations will be performed.
The mobile application will be introduced and downloaded to the parent's cell phone.
An 8-week training program will be provided through the application.
After one month, the scales will be reapplied during the interim follow-up and the BMI will be calculated.
At the end of the second month, the scales will be reapplied for the final test and the BMI will be calculated.
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With the support of computer engineers and software experts, the logo, user interface, overall appearance, and control panel will be designed to suit the purpose and subject matter of the mobile application.
The mobile application will be designed to be used on both Android and iOS-based smartphones and in environments without internet access.
After developing the prototype of the mobile application, its usability will be tested.
In this context, the testing process will first be carried out by researchers.
Academic nurses (n=3) and outpatient clinic nurses (n=2) will evaluate the application using the Mobile Application Usability Scale.
If any problems are identified in the application, they will be resolved and the necessary adjustments will be made.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Eating Attitude Test for Children
Time Frame: At baseline, 4 weeks after the start of the intervention, and 8 weeks after the start of the intervention
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This scale is used to identify eating-related attitudes and behaviors among children aged 8-15.
It consists of 26 items and evaluates general patterns indicating how children feel, think, and behave regarding eating, using a six-point Likert-type structure.
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At baseline, 4 weeks after the start of the intervention, and 8 weeks after the start of the intervention
|
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Eating Awareness Scale for Children
Time Frame: At baseline, 4 weeks after the start of the intervention, and 8 weeks after the start of the intervention
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This scale assesses the level of attention children aged 8-11 pay to food during eating behaviors and evaluates inattentive or automatic eating tendencies through its 12-item, two-dimension structure, using a four-point Likert-type format.
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At baseline, 4 weeks after the start of the intervention, and 8 weeks after the start of the intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Healthy Eating Self Efficacy Scale for Children
Time Frame: At baseline, 4 weeks after the start of the intervention, and 8 weeks after the start of the intervention
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This scale measures children's confidence in their ability to make healthy food choices and maintain healthy eating behaviors.
It evaluates their perceived capability to engage in healthy eating practices and is designed for children aged 8-10.
The scale consists of 9 items and uses a three-point Likert-type structure.
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At baseline, 4 weeks after the start of the intervention, and 8 weeks after the start of the intervention
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Body Mass Index
Time Frame: At baseline, 4 weeks after the start of the intervention, and 8 weeks after the start of the intervention
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Height and weight measurements will be used to calculate BMI (kg/m²) in participants.
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At baseline, 4 weeks after the start of the intervention, and 8 weeks after the start of the intervention
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: İlknur Yıldız, Associate Professor, Sivas Cumhuriyet University, Faculty of Health Sciences
Publications and helpful links
General Publications
- Kocaadam-Bozkurt, B., Köksal, E., & Özalp Ateş, F. S. (2022). Mindful Eating Questionnaire for Children: Validation and reliability in Turkish children. Mindfulness, 13, 1469-1478. https://doi.org/10.1007/s12671-022-01889-5.
- Browne NT. Obesity and Children. Nurs Clin North Am. 2021 Dec;56(4):583-597. doi: 10.1016/j.cnur.2021.07.006.
- Bozkurt O, Kocaadam-Bozkurt B, Koksal E, Ozalp Ates FS. Children's eating attitudes test (ChEAT): validation and reliability in Turkish children. J Eat Disord. 2023 Aug 31;11(1):93. doi: 10.1186/s40337-023-00811-1.
- Kabasakal, E., Arslan, U. E., Üner, S., Konşuk Ünlü, H., Bilir, N., Yardım, M. S., Araz, Ö., Huang, T., & Özcebe, H. (2020). The Turkish validity and reliability study of the Healthy Eating Self-Efficacy Scale for Children. Türkiye Çocuk Hastalıkları Dergisi / Turkish Journal of Pediatric Disease, 14(1), 1-10. https://doi.org/10.12956/tchd.556078.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCÜ-HMŞ-NK-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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