Clinical trial NCT05399446: Multi-Site Eating Disorder Prevention Program for Type 1 Diabetes
Official title: Multi-site Trial of a Virtually Delivered Eating Disorder Prevention Program for Young People with Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Eating Disorders
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Juvenile Diabetes Research Foundation
name: University of Minnesota
name: Joslin Diabetes Center
name: Stanford University
name: Amsterdam UMC, location VUmc
First posted: 2022-06-01
Enrollment: 280
Sex: ALL
Minimum age (years): 14
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 criteria: 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 outcomes:
measure: Change over time in Ideal Body Beliefs
timeFrame: pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention]
measure: Change over time in Body Dissatisfaction
timeFrame: pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention]
measure: Change over time in Diabetes-Specific Eating Pathology
timeFrame: pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention]
measure: Change in Eating Disorder Symptoms
timeFrame: pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention]
Secondary outcomes:
measure: Change in Glycemic Control
timeFrame: pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention]
measure: Change in Time-In-Range (TIR)
timeFrame: pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention]
measure: Change in Health Care Utilization
timeFrame: pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention]
measure: Change over time in Diabetes-Specific Distress
timeFrame: pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention]
measure: Change over time in Diabetes-Related Quality of Life
timeFrame: pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention]
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
city: Amsterdam
country: Netherlands
facility: Amsterdam Medical University Center
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Line Wisting, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Eric Stice, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Joslin Diabetes Center
name: Elena Toschi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Amsterdam Medical University Centers
name: Maartje de Wit, PhD
role: PRINCIPAL_INVESTIGATOR
References: