Eating Disorder Prevention Program for Type 1 Diabetes

Recruiting at 3 trial locations

Overseen By Eric Stice, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Oslo University Hospital

Must be taking: Insulin

Disqualifiers: Eating disorder hospitalization, DKA, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

280 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, since participants must be using insulin, it seems you will need to continue with your insulin treatment.

What data supports the effectiveness of the Diabetes Body Project treatment for preventing eating disorders in young women with type 1 diabetes?

Research shows that the Diabetes Body Project, adapted from the Body Project, is being evaluated for its ability to reduce eating disorder risk factors and symptoms in young women with type 1 diabetes. Preliminary studies suggest it is feasible and may be effective in this group. ^{1 2 3 4 5}

Is the Eating Disorder Prevention Program for Type 1 Diabetes safe for humans?

The research does not specifically mention safety concerns for the Eating Disorder Prevention Program, but it is based on the Body Project, which is a well-established program for preventing eating disorders. Generally, such programs are considered safe as they focus on education and behavior change. ^{1 4 5 6 7}

How is the Diabetes Body Project treatment different from other treatments for eating disorders in type 1 diabetes?

The Diabetes Body Project is unique because it is a virtual program specifically adapted to prevent eating disorders in young women with type 1 diabetes, focusing on reducing risk factors and symptoms through a tailored approach, unlike standard treatments which often have poorer outcomes in this group. ^{1 3 4 8 9}

Research Team

Line Wisting, PhD

Principal Investigator

Oslo University Hospital

Eric Stice, PhD

Principal Investigator

Stanford University

Elena Toschi, MD

Principal Investigator

Joslin Diabetes Center

Maartje de Wit, PhD

Principal Investigator

Amsterdam Medical University Centers

Eligibility Criteria

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.

Inclusion Criteria

You are worried about your appearance to some extent.

I have been diagnosed with Type 1 Diabetes for at least a year.

I am currently using insulin.

Exclusion Criteria

You do not have any worries about how your body looks.

Does not have access to wifi (will need for the virtual groups)

I am not willing to be video-recorded for the Diabetes Body Project.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the Diabetes Body Project (DBP) or an educational control program

6 weeks

Weekly virtual sessions

Follow-up

Participants are monitored for changes in body image, eating pathology, and glycemic control

2 years

Assessments at 6 months, 1 year, and 2 years post-intervention

Treatment Details

Interventions

• Diabetes Body Project

Trial Overview 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.

Participant Groups

Group I: Diabetes Body Project Experimental Treatment 1 Intervention

Group II: Educational Group Active Control 1 Intervention

Who Is Running the Clinical Trial?

Oslo University Hospital

Lead Sponsor

Trials

1,132

Recruited

7,856,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Joslin Diabetes Center

Collaborator

Trials

98

Recruited

26,500+

Amsterdam UMC, location VUmc

Collaborator

Trials

421

Recruited

218,000+

Juvenile Diabetes Research Foundation

Collaborator

Trials

237

Recruited

142,000+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Evaluation of a novel eating disorder prevention program for young women with type 1 diabetes: A preliminary randomized trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Changes in body image and onset of disordered eating behaviors in youth with type 1 diabetes over a five-year longitudinal follow-up. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Disturbed Eating Behaviors in Youth with Type 1 Diabetes: An Exploratory Study about Challenges in Diagnosis. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Feasibility of a virtually delivered eating disorder prevention program for young females with type 1 diabetes. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Disturbed eating behaviors and eating disorders in type 1 diabetes: clinical significance and treatment recommendations. [2022]

6. Israel pubmed.ncbi.nlm.nih.gov

[Eating disturbances in adolescent girls with type 1 diabetes mellitus]. [2015]

7. England pubmed.ncbi.nlm.nih.gov

Self-reported history of overweight and its relationship to disordered eating in adolescent girls with Type 1 diabetes. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Prevention and early help for eating disorders in young people with type 1 diabetes. [2021]

9. England pubmed.ncbi.nlm.nih.gov

"I am not alone". A qualitative feasibility study of eating disorders prevention groups for young females with type 1 diabetes. [2023]