Interactive Educational Video for Paediatric Type 1 Diabetes

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Conditions studied: Diabete Type 1, Educational Videos

In brief

The primary aim of this study is to evaluate the effectiveness of an interactive educational video (Luca's Journey: Managing Type 1 Diabetes) delivered in addition to the standard educational programme, in improving metabolic control in children with type 1 diabetes mellitus, specifically focusing on the change in glycated haemoglobin (HbA1c) levels between baseline (T0) and six-month follow-up (T3). The study will also assess the effectiveness of the intervention in improving fasting blood glucose levels, frequency of hypoglycaemic and hyperglycaemic episodes, clinical and anthropometric variables (blood pressure, body weight, BMI, and waist circumference), acquisition of nutritional knowledge based on recommendations for the management of type 1 diabetes, and adherence to the main type 1 diabetes management activities. The secondary objectives were to compare the two educational modalities (intervention vs. standard educational programme) in terms of: (i) mean between-group difference in the change in fasting blood glucose levels and frequency of hypoglycaemic and hyperglycaemic episodes; (ii) mean between-group difference in the change in clinical and anthropometric variables; (iii) acquisition of nutritional knowledge based on recommendations for the management of type 1 diabetes; and (iv) adherence to the main type 1 diabetes management activities. The main research questions addressed in this study are: Does the interactive educational video improve metabolic control, as measured by HbA1c levels, in children with type 1 diabetes compared to standard education alone? Does the intervention lead to a greater reduction in fasting blood glucose levels and a lower frequency of hypoglycaemic and hyperglycaemic episodes? Does the intervention improve clinical and anthropometric variables compared to standard education alone? Does the intervention lead to a greater acquisition of nutritional knowledge in children with type 1 diabetes? Does the intervention improve adherence to the main type 1 diabetes management activities, including insulin administration, blood glucose monitoring, dietary behaviours, and physical activity? Both study groups will receive the standard in-person educational programme, as routinely delivered at the outpatient clinic of the Regional Centre for Paediatric Diabetology of the "SS. Annunziata" University Hospital in Chieti. Participants assigned to the intervention group will additionally receive a 25-minute interactive educational video immediately following the standard educational session. The interactive video follows a child with type 1 diabetes through everyday situations, inviting participants to make decisions at key moments and explore the consequences of different behavioural choices related to diabetes management.

Key facts

Study ID

NCT07639307

Run by

G. d'Annunzio University

People needed

110

Starts

2027-01-01

Expected to finish

2028-01-01

Last updated by the study team

2026-06-10

Who can join

Age: 8 and older, up to 14. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female children aged between 8 and 14 years
• Diagnosis of type 1 diabetes mellitus for at least 6 months
• Ability to understand and communicate in Italian
• Absence of psychiatric disorders
• Absence of cognitive impairment
• Ability to use digital devices (e.g., computer)
• Written informed consent for study participation and personal data-processing provided by both parents or the legal guardian

You may not qualify if…

• Age younger than 8 years or older than 14 years
• Diagnosis of type 1 diabetes mellitus for less than 6 months
• Inability to understand or communicate in Italian
• Presence of psychiatric disorders
• Presence of cognitive impairment
• Inability to use digital devices (e.g., computer)
• Refusal of assent by the child
• Failure to provide written informed consent for study participation and personal data processing by both parents or the legal guardian

Full record on ClinicalTrials.gov

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