Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05399446

Multi-Site Eating Disorder Prevention Program for Type 1 Diabetes

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Eating Disorders Endocrine System Diseases Feeding and Eating Disorders Glucose Metabolism Disorders Immune System Diseases Mental Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

14 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amsterdam Medical University Center, Amsterdam, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diabetes Body Project

Behavioral

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

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  1. Change in Glycemic Control

    Time frame: 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)

  2. Change in Time-In-Range (TIR)

    Time frame: 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

  3. Change in Health Care Utilization

    Time frame: 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

  4. Change over time in Diabetes-Specific Distress

    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 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

  5. Change over time in Diabetes-Related Quality of Life

    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 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.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Amsterdam UMC, location VUmc
  • Joslin Diabetes Center
  • Juvenile Diabetes Research Foundation
  • Stanford University
  • University of Minnesota

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jun 1, 2022
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.