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Behavioral Intervention
Eating Disorder Prevention Program for Type 1 Diabetes
N/A
Recruiting
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
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 belowSelect...
I am currently using insulin.
Select...
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:Select...
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.
Select...
I am not between the ages of 14 and 35.
Timeline
Screening ~ 3 weeks3 visits
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]
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]
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 moreSecondary study objectives
Change in Glycemic Control
Change in Health Care Utilization
Change in Time-In-Range (TIR)
+2 moreTrial 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
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17,492,114 Total Patients Enrolled
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Joslin Diabetes CenterOTHER
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Amsterdam UMC, location VUmcOTHER
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212,922 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You do not have any worries about how your body looks.You are worried about your appearance to some extent.I am not willing to be video-recorded for the Diabetes Body Project.You have difficulty understanding and communicating in the language used for the group sessions, or you have conditions that make it hard for you to take part in the intervention sessions and study.I have been diagnosed with Type 1 Diabetes for at least a year.I had a severe eating disorder-related complication affecting my blood sugar in the last year.I am currently using insulin.I was diagnosed with Type 1 Diabetes less than a year ago.I do not use insulin.I am between 14 and 35 years old.I was hospitalized for an eating disorder in the last year.I am not between the ages of 14 and 35.
Research Study Groups:
This trial has the following groups:- Group 1: Diabetes Body Project
- Group 2: Educational Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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