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Clinical Trials/NCT05399446
NCT05399446
Active, not recruiting
Not Applicable

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

Oslo University Hospital4 sites in 3 countries280 target enrollmentJanuary 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 1 Diabetes
Sponsor
Oslo University Hospital
Enrollment
280
Locations
4
Primary Endpoint
Change over time in Ideal Body Beliefs
Status
Active, not recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2023
End Date
January 2027
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Oslo University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Line Wisting

Researcher

Oslo University Hospital

Eligibility Criteria

Inclusion Criteria

  • between the ages of 14-35
  • diagnosis of Type 1 Diabetes of at least 1 year
  • using insulin
  • experiencing at least some level of body image concerns

Exclusion Criteria

  • not between the ages of 14-35
  • does not have access to wifi (will need for the virtual groups)
  • Type 1 Diabetes diagnosis of less than 1 year
  • does not live in the same time zone of Stanford (helps in coordinating groups)
  • hospitalized for eating disorder treatment in the past year
  • had eating-disorder related Diabetic Ketoacidosis (DKA) in the past year
  • not using insulin
  • not experiencing any level of body image concerns
  • Unwilling to be video-recorded if assigned to Diabetes Body Project
  • 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.

Outcomes

Primary Outcomes

Change over time in Ideal Body Beliefs

Time Frame: pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention]

Assessed with the 8-item Ideal-Body Stereotype Scale-Revised (Stice et al., 2017) which measures pursuit of the thin ideal. Each item is scored on a scale of 1 = strongly disagree to 5 = strongly agree. Higher scores indicate greater belief in the thin-deal.

Change over time in Diabetes-Specific Eating Pathology

Time Frame: pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention]

Assessed with the 16-item Diabetes Eating Problem Survey-Revised (DEPS-R; Markowitz et al,.2010). Each item is assessed on a scale of 0 = Never to 5= Always. Higher scores indicate greater eating pathology specific to individuals with Type 1 Diabetes such as purposefully not taking enough insulin.

Change over time in Body Dissatisfaction

Time Frame: pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention]

Assessed with the 10-item Body Dissatisfaction Scale (BDI; Berscheid et al., 2973) which assesses dissatisfaction with various body parts. Each item is scored on a scale of 1 = extremely dissatisfied to 5 = extremely satisfied. Lower scores indicate greater body dissatisfaction.

Change in Eating Disorder Symptoms

Time Frame: pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention]

Participants will complete a diagnostic interview that is administered by a trained research assistant. We will be using the Eating Disorder Diagnostic Interview (EDDI). Scores are not reported on a scale. The research assistant who conducts the diagnostic interview at post-test and 3-month follow-up will be blinded to the person's condition.

Secondary Outcomes

  • Change in Glycemic Control(pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention])
  • Change in Health Care Utilization(pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention])
  • Change over time in Diabetes-Related Quality of Life(pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention])
  • Change in Time-In-Range (TIR)(pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention])
  • Change over time in Diabetes-Specific Distress(pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention])

Study Sites (4)

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