Multi-Site Eating Disorder Prevention Program for Type 1 Diabetes

NCT ID: NCT05399446

Last Updated: 2024-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2027-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 1 Diabetes Eating Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators
The assessor completing the interview at each follow-up assessment following completion of the intervention will be blinded to the condition the participant was in.

Study Groups

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Diabetes Body Project

Group Type EXPERIMENTAL

Diabetes Body Project

Intervention Type BEHAVIORAL

The Diabetes Body Project (DBP) is an adapted version of the Body Project Prevention program designed specifically for individuals with Type 1 Diabetes. DBP consists of six weekly, one-hour long sessions. Group participants complete the exercises from the original Body Project and also new diabetes-specific content, drawn from Olmsted et al. (2002) that is delivered in a dissonance-based interactive format with Socratic questions from group leaders encourage participants to generate their own answers.

Educational Group

Group Type ACTIVE_COMPARATOR

Educational Group

Intervention Type BEHAVIORAL

We selected a T1D management/Eating disorder psychoeducational comparison condition to control for expectancy effects and demand characteristics. To match the Diabetes Body Project, the educational lectures will be delivered in 6 1-hour blocks. Topics include basic information about the various EDs, complications of ED behaviors, diabetes and body image, effects of dieting on blood glucose, and the risk of complications.

Interventions

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Diabetes Body Project

The Diabetes Body Project (DBP) is an adapted version of the Body Project Prevention program designed specifically for individuals with Type 1 Diabetes. DBP consists of six weekly, one-hour long sessions. Group participants complete the exercises from the original Body Project and also new diabetes-specific content, drawn from Olmsted et al. (2002) that is delivered in a dissonance-based interactive format with Socratic questions from group leaders encourage participants to generate their own answers.

Intervention Type BEHAVIORAL

Educational Group

We selected a T1D management/Eating disorder psychoeducational comparison condition to control for expectancy effects and demand characteristics. To match the Diabetes Body Project, the educational lectures will be delivered in 6 1-hour blocks. Topics include basic information about the various EDs, complications of ED behaviors, diabetes and body image, effects of dieting on blood glucose, and the risk of complications.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. between the ages of 14-35
2. diagnosis of Type 1 Diabetes of at least 1 year
3. using insulin
4. experiencing at least some level of body image concerns

Exclusion Criteria

1. not between the ages of 14-35
2. does not have access to wifi (will need for the virtual groups)
3. Type 1 Diabetes diagnosis of less than 1 year
4. does not live in the same time zone of Stanford (helps in coordinating groups)
5. hospitalized for eating disorder treatment in the past year
6. had eating-disorder related Diabetic Ketoacidosis (DKA) in the past year
7. not using insulin
8. not experiencing any level of body image concerns
9. Unwilling to be video-recorded if assigned to Diabetes Body Project
10. restricted proficiency in language that groups will be conducted in (dependent on location), and pervasive developmental, cognitive, or psychiatric limitations that compromise participation in the intervention sessions and study.
Minimum Eligible Age

14 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Juvenile Diabetes Research Foundation

OTHER

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role collaborator

Joslin Diabetes Center

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role collaborator

Amsterdam UMC, location VUmc

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Line Wisting

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Line Wisting, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Eric Stice, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Elena Toschi, MD

Role: PRINCIPAL_INVESTIGATOR

Joslin Diabetes Center

Maartje de Wit, PhD

Role: PRINCIPAL_INVESTIGATOR

Amsterdam Medical University Centers

Locations

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Stanford University

Stanford, California, United States

Site Status

Joslin Diabetes Center

Boston, Massachusetts, United States

Site Status

Amsterdam Medical University Center

Amsterdam, , Netherlands

Site Status

Oslo University Hospital

Oslo, , Norway

Site Status

Countries

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United States Netherlands Norway

References

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Haugvik S, Hennekes M, Stice E, de Wit M, Toschi E, Wisting L. The diabetes body project: Study protocol of a multi-site trial of a virtually delivered eating disorder prevention program for young women with type 1 diabetes. Diabet Med. 2024 Sep;41(9):e15334. doi: 10.1111/dme.15334. Epub 2024 May 9.

Reference Type DERIVED
PMID: 38721639 (View on PubMed)

Other Identifiers

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65953

Identifier Type: -

Identifier Source: org_study_id

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