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Behavioral Intervention

Eating Disorder Prevention Program for Type 1 Diabetes

N/A
Waitlist Available
Led By Elena Toschi, MD
Research Sponsored by Oslo University Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Using insulin
Diagnosis of Type 1 Diabetes of at least 1 year
Must not have
Unwilling to be video-recorded if assigned to Diabetes Body Project
Had eating-disorder related Diabetic Ketoacidosis (DKA) in the past year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention]
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether an evidence-based eating disorder prevention program, adapted for people with Type 1 Diabetes, is more effective than an educational control group in reducing body image concerns, eating pathology, and improving glycemic control.

Who is the study for?
This trial is for individuals aged 14-35 with Type 1 Diabetes (T1D) who have been diagnosed for at least a year, are using insulin, and have some body image concerns. It's not suitable for those without these concerns, with less than a year's diagnosis of T1D, or who've had recent severe eating disorder treatment.
What is being tested?
The study tests the Diabetes Body Project (DBP), an adaptation of the Body Project designed to prevent eating disorders in people with T1D. Participants will be compared to an educational control group to see if DBP reduces body image issues and improves both eating patterns and glycemic control.
What are the potential side effects?
Since this trial involves psychological interventions rather than medications, traditional side effects like you'd expect from drugs aren't applicable. However, participants may experience emotional discomfort discussing body image and eating habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am currently using insulin.
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I have been diagnosed with Type 1 Diabetes for at least a year.
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I am between 14 and 35 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not willing to be video-recorded for the Diabetes Body Project.
Select...
I had a severe eating disorder-related complication affecting my blood sugar in the last year.
Select...
I do not use insulin.
Select...
I was hospitalized for an eating disorder in the last year.
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I am not between the ages of 14 and 35.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention]
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention] for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Eating Disorder Symptoms
Change over time in Body Dissatisfaction
Change over time in Diabetes-Specific Eating Pathology
+1 more
Secondary study objectives
Change in Glycemic Control
Change in Health Care Utilization
Change in Time-In-Range (TIR)
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Diabetes Body ProjectExperimental Treatment1 Intervention
Group II: Educational GroupActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Diabetes Body Project
2022
N/A
~60

Find a Location

Who is running the clinical trial?

Stanford UniversityOTHER
2,484 Previous Clinical Trials
17,515,814 Total Patients Enrolled
Joslin Diabetes CenterOTHER
97 Previous Clinical Trials
26,284 Total Patients Enrolled
Amsterdam UMC, location VUmcOTHER
413 Previous Clinical Trials
216,459 Total Patients Enrolled
Oslo University HospitalLead Sponsor
1,111 Previous Clinical Trials
7,839,754 Total Patients Enrolled
Juvenile Diabetes Research FoundationOTHER
235 Previous Clinical Trials
142,161 Total Patients Enrolled
University of MinnesotaOTHER
1,436 Previous Clinical Trials
1,621,403 Total Patients Enrolled
Elena Toschi, MDPrincipal InvestigatorJoslin Diabetes Center
1 Previous Clinical Trials
35 Total Patients Enrolled
Maartje de Wit, PhDPrincipal InvestigatorAmsterdam Medical University Centers
Eric Stice, PhDPrincipal InvestigatorStanford University
14 Previous Clinical Trials
4,926 Total Patients Enrolled
Line Wisting, PhDPrincipal InvestigatorOslo University Hospital
2 Previous Clinical Trials
499 Total Patients Enrolled

Media Library

Diabetes Body Project (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05399446 — N/A
Type 1 Diabetes Research Study Groups: Diabetes Body Project, Educational Group
Type 1 Diabetes Clinical Trial 2023: Diabetes Body Project Highlights & Side Effects. Trial Name: NCT05399446 — N/A
Diabetes Body Project (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05399446 — N/A
~127 spots leftby Sep 2026
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