Multi-Site Eating Disorder Prevention Program for Type 1 Diabetes
- Conditions
- Type 1 DiabetesEating Disorders
- Interventions
- Behavioral: Diabetes Body ProjectBehavioral: Educational Group
- Registration Number
- NCT05399446
- Lead Sponsor
- Oslo University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 280
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Diabetes Body Project Diabetes Body Project - Educational Group Educational Group -
- Primary Outcome Measures
Name Time Method Change over time in Ideal Body Beliefs 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 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 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 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 Outcome Measures
Name Time Method 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] 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
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] 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.
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] 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
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] Objectively assessed HbA1c (at clinic or by a self-test kit)
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] TIR past 14 days, screen shot of device. Time-Above-Range (TAR) and Time-Below-Range (TBR) are also recorded
Trial Locations
- Locations (4)
Stanford University
🇺🇸Stanford, California, United States
Joslin Diabetes Center
🇺🇸Boston, Massachusetts, United States
Amsterdam Medical University Center
🇳🇱Amsterdam, Netherlands
Oslo University Hospital
🇳🇴Oslo, Norway