CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 55 enrolled
Drug / intervention
Diabetes Body Project +1 morebehavioral
Likely dose
Diabetes Body Project: 6 weekly 1-hour sessionsAI-extracted
Key inclusion· 5
  • Female-identifying
  • Aged 15-30 years old
  • Type 1 Diabetes diagnosis for at least 6 months per ADA criteria and currently taking insulin
  • Have visited their diabetes care provider in the past year
Key exclusion· 5
  • Not female-identifying
  • Outside age range (not 15-30 years)
  • Type 1 Diabetes diagnosis less than 6 months or not on insulin
  • Have not visited diabetes care provider in the past year

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05264376
NCT05264376N/ACompleted

Evaluating an Eating Disorder Prevention Program for Young Women With Type 1 Diabetes

Stanford University·interventional·Posted Mar 3, 2022·Updated Jan 7, 2025

In Brief

A clinical study evaluating Diabetes Body Project and Educational Control for Eating Disorders and Type 1 Diabetes. Completed, enrolled 55 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2023202420252026
First PostedMar 3, 2022
Enrollment StartMar 21, 2022
Primary CompletionApr 15, 2023
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 4.3 years ago

Interventions

Diabetes Body Projectbehavioral

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 Controlbehavioral

We selected a T1D management/Eating disorder psychoeducational comparison condition previously tested (Olmsted et al., 2002) to control for expectancy effects and demand characteristics. To match the Diabetes Body Project, the educational lectures by Dr. Olmsted 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.