Multi-Site Eating Disorder Prevention Program for Type 1 Diabetes

University of Oslo (UIO)

Status: Active, not recruiting

Conditions: Type 1 Diabetes; Eating Disorders

Treatments: Behavioral: Diabetes Body Project; Behavioral: Educational Group

Study type: Interventional

Funder types: Other

Identifiers

NCT05399446

65953

Details and patient eligibility

About

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.

Enrollment: 280 estimated patients

Sex: All

Ages: 14 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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280 participants in 2 patient groups

Diabetes Body Project

Experimental group

Treatment:

Behavioral: Diabetes Body Project

Educational Group

Active Comparator group

Treatment:

Behavioral: Educational Group