The diabetes body project: Study protocol of a multi-site trial of a virtually delivered eating disorder prevention program for young women with type 1 diabetes

Aim: Young women with type 1 diabetes are a high-risk population for eating disorders (ED). Prevention programs are lacking. In young women without diabetes, the Body Project has produced reductions in ED risk factors, ED symptoms and future ED onset. Therefore, the Body Project was adapted to type 1 diabetes, the Diabetes Body Project (DBP). In this protocol, we describe the multi-site randomized controlled trial (RCT) to evaluate efficacy of the DBP. Methods: This is an ongoing RCT with four sites (Europe and US). In total 280, 14–35 year-old, women with type 1 diabetes ≥1 year and some level of body image concerns will be recruited in 2023. Participants are randomized to either virtual DBP groups or an educational control. The study constitutes 5 measurement points distributed over 2 years. The primary aim is to test if DBP will produce significantly greater reductions in ED behaviours, ED symptoms and future ED onset. The secondary aim is to test if DBP has significantly greater improvements in diabetes distress, quality of life and glycaemic outcomes. Results: We expect that DBP will be more efficacious in reducing ED behaviours, ED symptoms and ED onset compared to the control condition. Additionally, we hope to gain new knowledge on how DBP may affect diabetes-related outcomes. Conclusions: If DBP proves efficacious, it has potential for immediate, clinical implementation at low-cost and may contribute to broad prevention of future ED onset among young women with type 1 diabetes. ClinicalTrials.gov Identifier: NCT05399446.: