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Behavioral Intervention
Eating Disorder Prevention Program for Type 1 Diabetes
N/A
Recruiting
Led By Maartje de Wit, PhD
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
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
Study 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.Check my eligibility
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.See study design
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.
Select...
I am between 14 and 35 years old.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Eating Disorder Symptoms
Change over time in Body Dissatisfaction
Change over time in Diabetes-Specific Eating Pathology
+1 moreSecondary outcome measures
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
2,400 Previous Clinical Trials
17,341,549 Total Patients Enrolled
19 Trials studying Eating Disorders
8,732 Patients Enrolled for Eating Disorders
Joslin Diabetes CenterOTHER
96 Previous Clinical Trials
26,326 Total Patients Enrolled
Amsterdam UMC, location VUmcOTHER
393 Previous Clinical Trials
201,235 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies available for eligible participants in this trial?
"The information hosted on clinicaltrials.gov does not suggest that this trial is currently recruiting participants, as the last update was made on July 10th 2022. Nonetheless, 1352 other studies are still open for enrollment at present time."
Answered by AI
Does this research study accept individuals aged 35 or above?
"This trial seeks participants aged 14 to 35 years old. There are 254 studies for young people below the age of consent, and 970 trials recruiting older adults over 65."
Answered by AI
Is there an opportunity to partake in this medical research?
"This experiment is recruiting 310 individuals afflicted with type 1 diabetes, autoimmunity and aged between 14-35. The core prerequisites for qualification include: a minimum age of fourteen years old, at least one year since diagnosement, insulin usage, and perceivable body image concerns."
Answered by AI
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