NCT05399446

Multi-Site Eating Disorder Prevention Program for Type 1 Diabetes

Multi-site Trial of a Virtually Delivered Eating Disorder Prevention Program for Young People with Type 1 Diabetes

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 14 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

This study aims to test the effectiveness of an evidence-based eating-disorder prevention program specifically targeted for individuals with Type 1 Diabetes (T1D) compared to an educational control group. The Diabetes Body Project (DBP), is an adaptation of the Body Project which is the only eating disorder prevention program to have repeatedly produced effects when evaluated by independent researchers, produced stronger effects than credible alternative interventions, and affected objective outcomes. DBP has been adapted slightly for individuals with T1D who are at ultra-high risk for eating disorders. The study aims to test the effectiveness of the DBP of reducing body image concerns and reducing eating pathology and improving glycemic control.

Conditions

• Type 1 Diabetes
• Eating Disorders

Interventions

Type	Name	Description
BEHAVIORAL	Diabetes Body Project	The Diabetes Body Project (DBP) is an adapted version of the Body Project Prevention program designed specifically for individuals with Type 1 Diabetes. DBP consists of six weekly, one-hour long sessions. Group participants complete the exercises from the original Body Project and also new diabetes-specific content, drawn from Olmsted et al. (2002) that is delivered in a dissonance-based interactive format with Socratic questions from group leaders encourage participants to generate their own answers.
BEHAVIORAL	Educational Group	We selected a T1D management/Eating disorder psychoeducational comparison condition to control for expectancy effects and demand characteristics. To match the Diabetes Body Project, the educational lectures will be delivered in 6 1-hour blocks. Topics include basic information about the various EDs, complications of ED behaviors, diabetes and body image, effects of dieting on blood glucose, and the risk of complications.

Timeline

• Start date: 2023-01-01
• Primary completion: 2026-09-01
• Completion: 2027-01-01
• First posted: 2022-06-01
• Last updated: 2024-10-04

Locations

4 sites across 3 countries: United States, Netherlands, Norway