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Clinical Trials in Norway / NCT05399446
Active, not recruiting Not applicable

Multi-Site Eating Disorder Prevention Program for Type 1 Diabetes

NCT05399446 · tracked via the Priya Life Science Norway tracker
Phase
Not applicable
Started
2023-01-01
Last updated
2024-10-04

Condition(s) studied

Type 1 DiabetesEating Disorders

Investigational drug(s) / intervention(s)

Diabetes Body ProjectEducational Group

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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
14 Years
Max age
35 Years
Healthy volunteers
No
Inclusion Criteria: 1. between the ages of 14-35 2. diagnosis of Type 1 Diabetes of at least 1 year 3. using insulin 4. experiencing at least some level of body image concerns Exclusion Criteria: 1. not between the ages of 14-35 2. does not have access to wifi (will need for the virtual groups) 3. Type 1 Diabetes diagnosis of less than 1 year 4. does not live in the same time zone of Stanford (helps in coordinating groups) 5. hospitalized for eating disorder treatment in the past year 6. had eating-disorder related Diabetic Ketoacidosis (DKA) in the past year 7. not using insulin 8. not experiencing any level of body image concerns 9. Unwilling to be video-recorded if assigned to Diabetes Body Project 10. restricted proficiency in language that groups will be conducted in (dependent on location), and pervasive developmental, cognitive, or psychiatric limitations that compromise participation in the intervention sessions and study.

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
Stanford University Stanford California
Joslin Diabetes Center Boston Massachusetts
Amsterdam Medical University Center Amsterdam Netherlands
Oslo University Hospital Oslo Norway

More Oslo University Hospital trials in Norway

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05399446 on ClinicalTrials.gov ↗ ← All trials in Norway