Multi-Site Eating Disorder Prevention Program for Type 1 Diabetes

NCT05399446 | Active Not Recruiting DMC

• 1 other identifier: 65953
• Study Type: interventional
• Target: 280
• Locations: 3 countries
• Sites: 4

Brief Summary

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.

Conditions

Type 1 Diabetes; Eating Disorders

Outcome Measures

Primary Outcomes (4)

• Change over time in Ideal Body Beliefs

  Assessed with the 8-item Ideal-Body Stereotype Scale-Revised (Stice et al., 2017) which measures pursuit of the thin ideal. Each item is scored on a scale of 1 = strongly disagree to 5 = strongly agree. Higher scores indicate greater belief in the thin-deal.

  pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention]

• Change over time in Body Dissatisfaction

  Assessed with the 10-item Body Dissatisfaction Scale (BDI; Berscheid et al., 2973) which assesses dissatisfaction with various body parts. Each item is scored on a scale of 1 = extremely dissatisfied to 5 = extremely satisfied. Lower scores indicate greater body dissatisfaction.

  pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention]

• Change over time in Diabetes-Specific Eating Pathology

  Assessed with the 16-item Diabetes Eating Problem Survey-Revised (DEPS-R; Markowitz et al,.2010). Each item is assessed on a scale of 0 = Never to 5= Always. Higher scores indicate greater eating pathology specific to individuals with Type 1 Diabetes such as purposefully not taking enough insulin.

  pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention]

• Change in Eating Disorder Symptoms

  Participants will complete a diagnostic interview that is administered by a trained research assistant. We will be using the Eating Disorder Diagnostic Interview (EDDI). Scores are not reported on a scale. The research assistant who conducts the diagnostic interview at post-test and 3-month follow-up will be blinded to the person's condition.

  pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention]

Secondary Outcomes (5)

• Change in Glycemic Control

  pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention]

• Change in Time-In-Range (TIR)

  pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention]

• Change in Health Care Utilization

  pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention]

• Change over time in Diabetes-Specific Distress

  pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention]

• Change over time in Diabetes-Related Quality of Life

  pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention]

Study Arms (2)

Diabetes Body Project

EXPERIMENTAL

Behavioral: Diabetes Body Project

Educational Group

ACTIVE COMPARATOR

Behavioral: Educational Group

Interventions

Diabetes Body Project 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.

Diabetes Body Project

Educational Group 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.

Educational Group

Eligibility Criteria

• Age: 14 Years - 35 Years
• Gender Eligibility Details: Groups are single-gendered. Most participants (280) will be female-identifying. Each site is also going to recruit 1 group (about 6 individuals) of male-identifying individuals as to pilot the intervention with men. In total, there will be about 30 male-identifying individuals for a total sample of 310.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• not between the ages of 14-35
• does not have access to wifi (will need for the virtual groups)
• Type 1 Diabetes diagnosis of less than 1 year
• does not live in the same time zone of Stanford (helps in coordinating groups)
• hospitalized for eating disorder treatment in the past year
• had eating-disorder related Diabetic Ketoacidosis (DKA) in the past year
• not using insulin
• not experiencing any level of body image concerns
• Unwilling to be video-recorded if assigned to Diabetes Body Project
• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead
• Juvenile Diabetes Research Foundation: collaborator
• University of Minnesota: collaborator
• Joslin Diabetes Center: collaborator
• Stanford University: collaborator
• Amsterdam UMC, location VUmc: collaborator

Study Sites (4)

Stanford University

Stanford, California, 94304, United States

Location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

Amsterdam Medical University Center

Amsterdam, Netherlands

Location

Oslo University Hospital

Oslo, Norway

Location

Related Publications (1)

• 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.

  PMID: 38721639 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Line Wisting, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

• Eric Stice, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Elena Toschi, MD

  Joslin Diabetes Center

  PRINCIPAL INVESTIGATOR

• Maartje de Wit, PhD

  Amsterdam Medical University Centers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 1, 2022
• Study Start: January 1, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); NL (1); NO (1)