Eating Disorder Prevention Program for Type 1 Diabetes

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program designed to prevent eating disorders in people with Type 1 Diabetes (T1D). It aims to reduce body image concerns and improve eating habits and blood sugar control. Participants will either engage in the Diabetes Body Project or join an educational group for comparison. Individuals who have had T1D for at least a year, use insulin, and struggle with body image concerns might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance the quality of life for those with T1D.

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 prior data suggests that this program is safe for individuals with Type 1 Diabetes?

Research shows that the Diabetes Body Project is a program designed to prevent eating disorders in people with Type 1 Diabetes (T1D). Although specific safety data for this version of the program is not available, it is based on the original Body Project. Independent studies have consistently shown positive results from the original program in preventing eating disorders.

Since the Diabetes Body Project builds on a well-researched and tested program, it is likely safe. However, due to the lack of specific safety data for this version, participants should consider this when deciding to join. Consulting a healthcare provider before participating in any trial ensures it aligns with individual health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Diabetes Body Project because it offers a novel approach to preventing eating disorders in people with Type 1 Diabetes. Unlike traditional treatments that focus primarily on managing blood sugar levels, this program targets the psychological aspects of living with diabetes, aiming to promote a healthier body image and reduce the risk of disordered eating. By incorporating body acceptance and self-compassion techniques, the Diabetes Body Project seeks to address the root causes of eating disorders, which are often overlooked in standard diabetes care. This innovative focus could lead to more comprehensive care and better overall well-being for individuals with Type 1 Diabetes.

What evidence suggests that the Diabetes Body Project is effective for preventing eating disorders in individuals with Type 1 Diabetes?

Research has shown that the Diabetes Body Project (DBP), one of the treatments in this trial, helps prevent eating disorders in people with Type 1 Diabetes (T1D). Studies have found that DBP leads to noticeable improvements compared to standard educational programs. Specifically, early trials demonstrated significant progress in reducing the risk and symptoms of eating disorders. The program is effective even when offered online, particularly in reducing symptoms in young women with T1D. Overall, the Diabetes Body Project appears to be a promising option for those at high risk of eating disorders. Participants in this trial may receive either the Diabetes Body Project or an Educational Group intervention. ^{1 5 6 7 8}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. diabetesjournals.org diabetesjournals.org/care/article/48/2/220/157535/Diabetes-Body-Project-Acute-Effects-of-an-Eating

Diabetes Body Project: Acute Effects of an Eating Disorder ... The Diabetes Body Project produced significantly larger acute effects with small to medium effect sizes compared with educational controls and has potential ...

2. tandfonline.com tandfonline.com/doi/full/10.1080/10640266.2024.2331391

within-subject changes over 6-month follow-up Conclusion: The virtual Diabetes Body Project appears to be a promising intervention worthy of more rigorous evaluation. A randomized controlled ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12434424/

Diabetes body project eating disorder prevention program ... Pilot trials have shown acceptability and meaningful preliminary improvements in outcomes, with overall medium to large effect sizes. , , Qualitative feedback ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S016882272300760X

Evaluation of a novel eating disorder prevention program ... Virtually delivered Diabetes Body Project decreased ED risk factors and symptoms in young women with type 1 diabetes.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38721639/

The diabetes body project: Study protocol of a multi-site ... The primary aim is to test if DBP will produce significantly greater reductions in ED behaviours, ED symptoms and future ED onset.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39602474/

Diabetes Body Project: Acute Effects of an Eating Disorder ... The Diabetes Body Project produced significantly larger acute effects with small to medium effect sizes compared with educational controls ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2666776224003740

Safety of a co-designed cognitive behavioural therapy ... There is no effective intervention that integrates type 1 diabetes and eating disorders treatment for those with mild to moderate presentations of T1DE in the ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05264376

Eating Disorder Prevention Program for Women With T1D This study aims to test the effectiveness of an evidence-based eating- disorder prevention program specifically targeted for individuals with Type 1 ...