Multi-Site Eating Disorder Prevention Program for Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05399446
• Other study ID #: 65953
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: January 2027

Study information

• Verified date: October 2023
• Source: Oslo University Hospital
• Contact: Shiraz Harel, BA
• Phone: 6502720461
• Email: shirazh[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: January 2027
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Eating Disorders
• Feeding and Eating Disorders
• Type 1 Diabetes

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Netherlands	Amsterdam Medical University Center	Amsterdam
Norway	Oslo University Hospital	Oslo
United States	Joslin Diabetes Center	Boston	Massachusetts
United States	Stanford University	Stanford	California

Sponsors (6)

Lead Sponsor	Collaborator
Oslo University Hospital	Amsterdam UMC, location VUmc, Joslin Diabetes Center, Juvenile Diabetes Research Foundation, Stanford University, University of Minnesota

Countries where clinical trial is conducted

United States,  Netherlands,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]
Primary	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]
Primary	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]
Primary	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	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]
Secondary	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]
Secondary	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]
Secondary	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]
Secondary	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]