Multi-Site Eating Disorder Prevention Program for Type 1 Diabetes
NCT ID: NCT05399446
Last Updated: 2024-10-04
Study Results
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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ACTIVE_NOT_RECRUITING
NA
280 participants
INTERVENTIONAL
2023-01-01
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Diabetes Body Project
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.
Educational Group
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
14 Years
35 Years
ALL
No
Sponsors
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Juvenile Diabetes Research Foundation
OTHER
University of Minnesota
OTHER
Joslin Diabetes Center
OTHER
Stanford University
OTHER
Amsterdam UMC, location VUmc
OTHER
Oslo University Hospital
OTHER
Responsible Party
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Line Wisting
Researcher
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
Joslin Diabetes Center
Boston, Massachusetts, United States
Amsterdam Medical University Center
Amsterdam, , Netherlands
Oslo University Hospital
Oslo, , Norway
Countries
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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.
Other Identifiers
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65953
Identifier Type: -
Identifier Source: org_study_id
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