Efficacy of the Online Interactive Podcast Program "Living With Type 1 Diabetes to Grown-Up": A Two-Arm Randomized Controlled Trial Protocol.

Abstract

Aim: The aim was to design a study protocol for evaluating the efficacy of an interactive podcast program to assist Type 1 diabetes patients transitioning from adolescence to young adulthood. Design: The study design is a parallel 1:1 two-arm randomized controlled trial emphasizing treatment fidelity through standardized interventions and improved adherence to reduce biases in outcomes. Methods: This theoretical-based study will be conducted at two medical centers in northern Taiwan, enrolling 88 participants. Participants will be randomly assigned to either the experimental group, receiving the interactive podcast program "Living With Type 1 Diabetes to Grown-Up," or the active control group, receiving the e-book "Transitioning from Adolescence to Early Adulthood: The Ins and Outs of Type 1 Diabetes." The 3-month intervention will release 36 podcast episodes at a rate of three per week. Data will be collected at baseline, postintervention, and at 3 and 6 months postintervention to evaluate the efficacy of the intervention on disease control outcomes, emotional distress, diabetes knowledge, self-care behaviors, self-management confidence, interpersonal distress, and family conflict. Conclusion: This first evidence-based, rigorously designed podcast program will offer valuable guidelines for future interventions aimed at helping adolescents with Type 1 diabetes transition to adulthood. Impact: This study's positive findings could support podcasts as an innovative tool for helping adolescents with Type 1 diabetes transition to young adulthood. Additionally, it may provide valuable insights for future research and health policymakers, potentially transforming diabetes management approaches. Reporting Method: The authors adhered to CONSORT guidelines to ensure transparency and reliability. Patient or Public Contribution: There is no patient or public contribution. This Paper Contributes to the Wider Global Clinical Community: This paper provides an evidence-based framework for using podcasts to support self-management and well-being in adolescents with Type 1 diabetes and offers insights for future digital health strategies. Trial Registration: ClinicalTrials.gov identifier: NCT06464640.