Multi-Site Eating Disorder Prevention Program for Type 1 Diabetes

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 1 Diabetes, Eating Disorders

Intervention / Treatment
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* Behavioral: Diabetes Body Project
* Behavioral: Educational Group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diabetes Body Project<br> | Behavioral: Diabetes Body Project<br>* 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.<br>|
| Active Comparator: Educational Group<br> | Behavioral: Educational Group<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change over time in Ideal Body Beliefs | 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. | 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 Body Dissatisfaction | 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. | 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 Eating Pathology | 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. | pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention] | 
| Change in Eating Disorder Symptoms | 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. | pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Glycemic Control | Objectively assessed HbA1c (at clinic or by a self-test kit) | 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) | TIR past 14 days, screen shot of device. Time-Above-Range (TAR) and Time-Below-Range (TBR) are also recorded | 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 | service utilization will be assessed with an adapted version of the Patterns of Help Seeking Behavior Scale (Lane & Addis, 2005). Participants in both conditions will be asked to report frequency of care the past year for physical, mental health, eating, and weight problem | 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 | Assessed with the 20-item Problem Areas In Diabetes scale (PAID) which measures distress related to diabetes. High scores indicate greater distress that are related to living with Type 1 Diabetes | 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 | Assessed with the adolescent version (23 items) (Hilliard et al., 2020)and young adult version (27-items) of Type 1 Diabetes and Life (T1DAL) measures (Hilliard et al., 2021)assess diabetes specific health-related quality of life among participants with T1D. Total scores are transformed to a 0-100 scale and enables comparison of scores across age ranges. Higher scores indicate greater distress. | pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention] |