Multi-Site Eating Disorder Prevention Program for Type 1 Diabetes

NCT05399446 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2024-10-04

No results posted yet for this study

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.

Conditions

Interventions

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.

BEHAVIORAL

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.

Sponsors & Collaborators

  • Juvenile Diabetes Research Foundation

    collaborator OTHER
  • University of Minnesota

    collaborator OTHER
  • Joslin Diabetes Center

    collaborator OTHER
  • Stanford University

    collaborator OTHER
  • Amsterdam UMC, location VUmc

    collaborator OTHER
  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Line Wisting, PhD · Oslo University Hospital

  • Eric Stice, PhD · Stanford University

  • Elena Toschi, MD · Joslin Diabetes Center

  • Maartje de Wit, PhD · Amsterdam Medical University Centers

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2026-09-30
Completion
2027-01-31

Countries

  • United States
  • Netherlands
  • Norway

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05399446 on ClinicalTrials.gov