An interventional study of Insulin Self-Management Know-Find-Solve Activity Book and Routine education in Type 1 Diabetes, Children and Activity, sponsored by Marmara University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 8 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by Marmara University · Not applicable, Interventional, and Supportive care
Children with type 1 diabetes require lifelong insulin therapy. However, improper management of insulin therapy may lead to serious, potentially life-threatening complications. The aim of this study is to examine the effect of an activity book developed for insulin therapy on insulin self-management among children with type 1 diabetes and their parents. The study is designed as a cluster randomized controlled experimental trial at the center level, including pre-test, 1- month, and 3-month follow-up measurements. The study will be initiated after obtaining ethical approval and institutional permissions. The sample will consist of children aged 8-12 years with type 1 diabetes and their parents. The study will be conducted in two different hospitals in Istanbul; using cluster randomization, one hospital will be assigned to the intervention group and the other to the control group. Prior to the main study, a pilot study will be conducted with 15 participants in each group, and the sample size will be calculated using G*Power based on the pilot data. Data will be collected using the "Descriptive Information Form for Children with Diabetes" and the "Insulin Treatment Self-Management Scale (ITSMS) - Child (8-18 years) and Parent Forms." The "Find-Solve-Learn Insulin Self-Management Activity Book" will be applied to the children in the intervention group. The children will be monitored to complete the activity book at least twice a month for three months, and feedback will be obtained from their families regarding the process. The data collection process will include pre-test, 1-month, and 3-month follow-up measurements. The obtained data will be analyzed using appropriate statistical methods.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's planned enrollment of 40 is close to the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
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Diagnosed with Type 1 diabetes Aged between 8 and 12 years Able to read and write Able to understand and speak Turkish Diagnosed with diabetes for at least one year Regularly attending routine three-month outpatient clinic follow-ups Having no other diseases or medical conditions aside from diabetes The child agrees to participate in the study
-For the Parent: Being the mother or father of the child with Type 1 diabetes Being the primary caregiver responsible for the child Able to read and write Agrees to participate in the study
Exclusion Criteria:
The child uses an insulin pump
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After the pre-test, children in the intervention group will receive the intervention using the "Insulin Self-Management Know-Find-Solve Activity Book," in addition to the standard education provided by diabetes nurses in accordance with the Ministry of Health Diabetes Educator Guide. The researcher will explain how to use the activity book, and the book will be given to the children to complete at home. Parents' contact information will be obtained, and children will be asked to complete the activities in the book at least twice a month for 3 months. Throughout the process, families will be contacted to monitor the implementation of the activities and to obtain feedback on the completed sections. Questions from children and parents regarding the activities will be answered by the researcher. Follow-up measurements will be conducted at the end of the 1st and 3rd months after the intervention.
Other: Insulin Self-Management Know-Find-Solve Activity Book
Children in the control group will not receive any additional intervention other than the standard education provided by diabetes nurses in accordance with the Ministry of Health Diabetes Educator Guide.
Other: Routine education
The Insulin Self-Management Find-Search-Solve Activity Book was developed based on national and international literature to improve insulin-related self-management skills in children aged 8-12 years with type 1 diabetes. It aims to help children distinguish correct and incorrect insulin practices, take responsibility, make appropriate decisions, and apply their knowledge in daily life. The erasable and reusable book was designed to be safe and child-friendly. It contains 19 activities across 22 pages, including puzzles, word searches, matching, coloring, fill-in-the-blanks, true-false questions, riddles, and identification of insulin injection sites. Six experts evaluated the book, and the overall Content Validity Index calculated using the Davis technique was 0.98. Following pilot testing, the book will be finalized according to participant feedback.
Parents' contact information will be obtained, and the follow-up process will be maintained. The same data collection tools will be administered at time points parallel to those of the intervention group. After completion of the study, in line with the principle of ethical equity, children in the control group will also be given the "Insulin Self-Management Know-Find-Solve Activity Book" as a gift.
Change in insulin self-management level among children with type 1 diabetes
The primary outcome is the change in insulin treatment-related self-management level of children with type 1 diabetes. Higher scores will indicate better insulin self-management.
Time frame: Baseline, 1 month after the intervention, and 3 months after the intervention
Change in parent-reported insulin treatment self-management level of children with type 1 diabetes
The secondary outcome is the change in parent-reported insulin treatment self-management level of children with type 1 diabetes.
Time frame: Baseline, 1 month after the intervention, and 3 months after the intervention
Validity of the Insulin Self-Management Find-Search-Solve Activity Book
The validity of the Insulin Self-Management Know-Find-Solve Activity Book will be evaluated as a pre-specified methodological outcome. Content validity will be assessed based on expert opinions using the Davis technique and the Content Validity Index. Face validity will be evaluated through pilot implementation with children with type 1 diabetes who meet the inclusion criteria. Feedback from children will be used to assess the clarity, comprehensibility, and suitability of the activity book.
Time frame: Baseline
Plan to share: No
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Marmara University