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| Name | Class |
|---|---|
| Juvenile Diabetes Research Foundation | OTHER |
| University of Minnesota | OTHER |
| Joslin Diabetes Center | OTHER |
| Stanford University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetes Body Project | Experimental |
| |
| Educational Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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] |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycemic Control | Objectively assessed HbA1c (at clinic or by a self-test kit) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94304 | United States | ||
| Joslin Diabetes Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38721639 | Derived | 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. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D001068 | Feeding and Eating Disorders |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| OTHER |
| Amsterdam UMC, location VUmc | OTHER |
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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.
|
| 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. |
|
TIR past 14 days, screen shot of device. Time-Above-Range (TAR) and Time-Below-Range (TBR) are also recorded |
| 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 | service utilization will be assessed with an adapted version of the Patterns of Help Seeking Behavior Scale (Lane & Addis, 2005). Participants in both conditions will be asked to report frequency of care the past year for physical, mental health, eating, and weight problem | 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 | Assessed with the 20-item Problem Areas In Diabetes scale (PAID) which measures distress related to diabetes. High scores indicate greater distress that are related to living with Type 1 Diabetes | 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 | Assessed with the adolescent version (23 items) (Hilliard et al., 2020)and young adult version (27-items) of Type 1 Diabetes and Life (T1DAL) measures (Hilliard et al., 2021)assess diabetes specific health-related quality of life among participants with T1D. Total scores are transformed to a 0-100 scale and enables comparison of scores across age ranges. Higher scores indicate greater distress. | pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention] |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Amsterdam Medical University Center | Amsterdam | Netherlands |
| Oslo University Hospital | Oslo | Norway |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |