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| ID | Type | Description | Link |
|---|---|---|---|
| P30DK116074 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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 Control 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 |
|---|---|---|
| Percentage of Time With Blood Sugar in Range as a Measure of Glycemic Control | Participants wore a continuous-glucose monitor for 14 days as well as self-reported A1c levels. The percentage of time that participants had blood sugar in range (70 to 180 mg/dL) is reported. | Three months following the 6-week intervention period |
| Eating Disorder Symptoms | Participants completed a diagnostic interview using the semi-structured Eating Disorder Diagnostic Interview (EDDI) was used to assess eating disorder symptoms, including frequency of binge eating, vomiting, laxative/diuretic use, fasting, and excessive exercise, as well as degree of overvaluation of weight/shape, feeling fat, and fear of weight gain. Participants were also asked about distress regarding binge eating, rapid eating, eating until uncomfortably full, eating large quantities of food when not hungry, eating alone because of embarrassment, and feeling disgusted, depressed, or guilty after binge eating. The research assistant administering the interview was blinded to the person's condition. Scores range from 0 to over 100 for the most severe cases. Higher scores indicate higher levels of eating disorder symptoms. Items assessing symptoms in the past month were summed to form a composite. | Assessed at week 6 (post-intervention) and three months following the 6-week intervention period |
| Body Dissatisfaction (BS) | Assessed with the 10-item Body Dissatisfaction Scale which assesses dissatisfaction with various body parts. Each item is scored on a scale of 1 = extremely dissatisfied to 6 = extremely satisfied. Item scores were averaged to create an overall score (1 to 6). Lower scores indicate greater body dissatisfaction. | Week 6 (post-intervention) and three months following the 6-week intervention period |
| Thin Ideal Internalization | Assessed with the 8-item Ideal-Body Stereotype Scale-Revised which measures pursuit of the thin ideal. Each item is scored on a scale of 1 = strongly disagree to 5 = strongly agree. Item scores were averaged to create an overall score (1 to 5). Higher scores indicate greater belief in the thin-deal. |
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Inclusion Criteria:
I)female-identifying II) aged 15-30 years old III) diagnosis of T1D for at least a 6-month duration per American Diabetes Association(ADA) criteria who are taking insulin IV) have visited their diabetes care provider in the past year V) body image concerns
Exclusion Criteria:
I) not female identifying II) not in age range III) does not have a diagnosis of T1D for at least 6 months per ADA criteria who are taking insulin IV) have not visited their diabetes care provider in the past year V) do not report some level of body dissatisfaction
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| Name | Affiliation | Role |
|---|---|---|
| Eric Stice, PhD | Stanford University | Principal Investigator |
| Korey Hood, MDPhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27709979 | Background | Stice E, Gau JM, Rohde P, Shaw H. Risk factors that predict future onset of each DSM-5 eating disorder: Predictive specificity in high-risk adolescent females. J Abnorm Psychol. 2017 Jan;126(1):38-51. doi: 10.1037/abn0000219. Epub 2016 Oct 6. | |
| 20032278 | Background | Markowitz JT, Butler DA, Volkening LK, Antisdel JE, Anderson BJ, Laffel LM. Brief screening tool for disordered eating in diabetes: internal consistency and external validity in a contemporary sample of pediatric patients with type 1 diabetes. Diabetes Care. 2010 Mar;33(3):495-500. doi: 10.2337/dc09-1890. Epub 2009 Dec 23. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Educational Control Group | Educational Control: We selected a T1D management/Eating disorder psychoeducational comparison condition previously tested (Olmsted et al., 2002) to control for expectancy effects and demand characteristics. To match the Diabetes Body Project, the educational lectures by Dr. Olmsted 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Time With Blood Sugar in Range as a Measure of Glycemic Control | Participants wore a continuous-glucose monitor for 14 days as well as self-reported A1c levels. The percentage of time that participants had blood sugar in range (70 to 180 mg/dL) is reported. | Posted | Mean | Standard Deviation | percentage of time | Three months following the 6-week intervention period |
|
6-week intervention period plus 3-month follow-up period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eric Stice | Stanford University | 650-723-7885 | estice@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 31, 2023 | Jul 31, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 31, 2024 | Jul 31, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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The Diabetes Body Project and educational control are both designed to last six weeks, for one hour each week. They both focus on diabetes-specific health issues as well as generic issues with thin-idealization.
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The research assistant conducting the diagnostic interviews after the end of the prevention program and at 3-month follow-up won't know whether the participant was in the Diabetes Body Project or the educational control group.
|
| Educational Control | Behavioral | We selected a T1D management/Eating disorder psychoeducational comparison condition previously tested (Olmsted et al., 2002) to control for expectancy effects and demand characteristics. To match the Diabetes Body Project, the educational lectures by Dr. Olmsted 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. |
|
| Week 6 (post-intervention) and three months following the 6-week intervention period |
| Diabetes-Specific Eating Pathology | Assessed with the 16-item Diabetes Eating Problem Survey-Revised. Each item is assessed on a scale of 0 = Never to 5= Always. Item scores were averaged to create an overall score (0 to 5). Higher scores indicate greater eating pathology specific to individuals with Type 1 Diabetes such as purposefully not taking enough insulin. | Week 6 (post-intervention) and three months following the 6-week intervention period |
| Diabetes-Specific Distress | Assessed with the 28-item Type 1 Diabetes Distress Scale which measures distress related to diabetes. Each item is assessed on a scale of 1 = Not a Problem to 6 = A Very Serious Problem. Item scores were averaged to create an overall score (1 to 6). High scores indicate greater distress that are related to living with Type 1 Diabetes. | Week 6 (post-intervention) and three months following the 6-week intervention period |
| Negative Affect | Negative affect will be assessed with the sadness, guilt, and fear/anxiety subscales (totaling 20 items) from the Positive Affect and Negative Affect Scale-Revised. Each item is scored on a scale of 1 = Not at All to 5 = Extremely. Item scores were averaged to create an overall score (1 to 5) Higher scores indicate greater negative affect. | Week 6 (post-intervention) and three months following the 6-week intervention period |
| Quality of Life (Well-Being) | Assessed with the 5-item World Health Organization Well-Being Index that measures health related quality of life. Each item is scored on a scale of 0 = At no Time to 5 = All of the Time. Item scores were averaged to create an overall score (0 to 5). Higher scores indicate greater well-being. | Week 6 (post-intervention) and three months following the 6-week intervention period |
| 25765489 | Background | Fisher L, Polonsky WH, Hessler DM, Masharani U, Blumer I, Peters AL, Strycker LA, Bowyer V. Understanding the sources of diabetes distress in adults with type 1 diabetes. J Diabetes Complications. 2015 May-Jun;29(4):572-7. doi: 10.1016/j.jdiacomp.2015.01.012. Epub 2015 Feb 7. |
| 3397865 | Background | Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063. |
| 17475940 | Background | de Wit M, Pouwer F, Gemke RJ, Delemarre-van de Waal HA, Snoek FJ. Validation of the WHO-5 Well-Being Index in adolescents with type 1 diabetes. Diabetes Care. 2007 Aug;30(8):2003-6. doi: 10.2337/dc07-0447. Epub 2007 May 2. |
| 37951479 | Result | Stice E, Wisting L, Desjardins CD, Hood KK, Hanes S, Rubino L, Shaw H. Evaluation of a novel eating disorder prevention program for young women with type 1 diabetes: A preliminary randomized trial. Diabetes Res Clin Pract. 2023 Dec;206:110997. doi: 10.1016/j.diabres.2023.110997. Epub 2023 Nov 10. |
| BG001 | Educational Control Group | Educational Control: We selected a T1D management/Eating disorder psychoeducational comparison condition previously tested (Olmsted et al., 2002) to control for expectancy effects and demand characteristics. To match the Diabetes Body Project, the educational lectures by Dr. Olmsted 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Thin-Ideal Internalization | 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. Item scores were averaged to create an overall score (1 to 5). Higher scores indicate greater belief in the thin-deal. | Mean | Standard Deviation | score on a scale |
|
| Body Dissatisfaction (BS) | Assessed with the 10-item Body Dissatisfaction Scale which assesses dissatisfaction with various body parts. Each item is scored on a scale of 1 = extremely dissatisfied to 6 = extremely satisfied. Item scores were averaged to create an overall score (1 to 6). Lower scores indicate greater body dissatisfaction. | Mean | Standard Deviation | score on a scale |
|
| Negative Affect | Negative affect will be assessed with the sadness, guilt, and fear/anxiety subscales (totaling 20 items) from the Positive Affect and Negative Affect Scale-Revised. Each item is scored on a scale of 1 = Not at All to 5 = Extremely. Item scores were averaged to create an overall score (1 to 5) Higher scores indicate greater negative affect. | Mean | Standard Deviation | score on a scale |
|
| Eating Disorder Symptoms | Eating Disorder Symptoms: Scores range from 0 to over 100 for the most severe cases. Higher scores indicate higher levels of eating disorder symptoms. Items assessing symptoms in the past month were summed to form a composite. | Mean | Standard Deviation | composite score |
|
| Diabetes eating pathology | Assessed with the 16-item Diabetes Eating Problem Survey-Revised. Each item is assessed on a scale of 0 = Never to 5= Always. Item scores were averaged to create an overall score (0 to 5). Higher scores indicate greater eating pathology specific to individuals with Type 1 Diabetes such as purposefully not taking enough insulin. | Mean | Standard Deviation | score on a scale |
|
| Diabetes Distress | Assessed with the 28-item Type 1 Diabetes Distress Scale which measures distress related to diabetes. Each item is assessed on a scale of 1 = Not a Problem to 6 = A Very Serious Problem. Item scores were averaged to create an overall score (1 to 6). High scores indicate greater distress that are related to living with Type 1 Diabetes. | Mean | Standard Deviation | score on a scale |
|
| Quality of Life | Assessed with the 5-item World Health Organization Well-Being Index that measures health related quality of life. Each item is scored on a scale of 0 = At no Time to 5 = All of the Time. Item scores were averaged to create an overall score (0 to 5). Higher scores indicate greater well-being. | Mean | Standard Deviation | score on a scale |
|
| Percentage of Time With Blood Sugar in Range | Participants wore a continuous-glucose monitor for 14 days as well as self-reported A1c levels. The percentage of time that participants had blood sugar in range (70 to 180 mg/dL) is reported. | Mean | Standard Deviation | percentage of time |
|
| Education | Count of Participants | Participants |
|
| OG001 | Educational Control Group | Educational Control: We selected a T1D management/Eating disorder psychoeducational comparison condition previously tested (Olmsted et al., 2002) to control for expectancy effects and demand characteristics. To match the Diabetes Body Project, the educational lectures by Dr. Olmsted 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. |
|
|
| Primary | Eating Disorder Symptoms | Participants completed a diagnostic interview using the semi-structured Eating Disorder Diagnostic Interview (EDDI) was used to assess eating disorder symptoms, including frequency of binge eating, vomiting, laxative/diuretic use, fasting, and excessive exercise, as well as degree of overvaluation of weight/shape, feeling fat, and fear of weight gain. Participants were also asked about distress regarding binge eating, rapid eating, eating until uncomfortably full, eating large quantities of food when not hungry, eating alone because of embarrassment, and feeling disgusted, depressed, or guilty after binge eating. The research assistant administering the interview was blinded to the person's condition. Scores range from 0 to over 100 for the most severe cases. Higher scores indicate higher levels of eating disorder symptoms. Items assessing symptoms in the past month were summed to form a composite. | Posted | Mean | Standard Deviation | composite score | Assessed at week 6 (post-intervention) and three months following the 6-week intervention period |
|
|
|
| Primary | Body Dissatisfaction (BS) | Assessed with the 10-item Body Dissatisfaction Scale which assesses dissatisfaction with various body parts. Each item is scored on a scale of 1 = extremely dissatisfied to 6 = extremely satisfied. Item scores were averaged to create an overall score (1 to 6). Lower scores indicate greater body dissatisfaction. | Posted | Mean | Standard Deviation | score on a scale | Week 6 (post-intervention) and three months following the 6-week intervention period |
|
|
|
| Primary | Thin Ideal Internalization | Assessed with the 8-item Ideal-Body Stereotype Scale-Revised which measures pursuit of the thin ideal. Each item is scored on a scale of 1 = strongly disagree to 5 = strongly agree. Item scores were averaged to create an overall score (1 to 5). Higher scores indicate greater belief in the thin-deal. | Posted | Mean | Standard Deviation | score on a scale | Week 6 (post-intervention) and three months following the 6-week intervention period |
|
|
|
| Primary | Diabetes-Specific Eating Pathology | Assessed with the 16-item Diabetes Eating Problem Survey-Revised. Each item is assessed on a scale of 0 = Never to 5= Always. Item scores were averaged to create an overall score (0 to 5). Higher scores indicate greater eating pathology specific to individuals with Type 1 Diabetes such as purposefully not taking enough insulin. | Posted | Mean | Standard Deviation | score on a scale | Week 6 (post-intervention) and three months following the 6-week intervention period |
|
|
|
| Primary | Diabetes-Specific Distress | Assessed with the 28-item Type 1 Diabetes Distress Scale which measures distress related to diabetes. Each item is assessed on a scale of 1 = Not a Problem to 6 = A Very Serious Problem. Item scores were averaged to create an overall score (1 to 6). High scores indicate greater distress that are related to living with Type 1 Diabetes. | Posted | Mean | Standard Deviation | score on a scale | Week 6 (post-intervention) and three months following the 6-week intervention period |
|
|
|
| Primary | Negative Affect | Negative affect will be assessed with the sadness, guilt, and fear/anxiety subscales (totaling 20 items) from the Positive Affect and Negative Affect Scale-Revised. Each item is scored on a scale of 1 = Not at All to 5 = Extremely. Item scores were averaged to create an overall score (1 to 5) Higher scores indicate greater negative affect. | Posted | Mean | Standard Deviation | score on a scale | Week 6 (post-intervention) and three months following the 6-week intervention period |
|
|
|
| Primary | Quality of Life (Well-Being) | Assessed with the 5-item World Health Organization Well-Being Index that measures health related quality of life. Each item is scored on a scale of 0 = At no Time to 5 = All of the Time. Item scores were averaged to create an overall score (0 to 5). Higher scores indicate greater well-being. | Posted | Mean | Standard Deviation | score on a scale | Week 6 (post-intervention) and three months following the 6-week intervention period |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Educational Control Group | Educational Control: We selected a T1D management/Eating disorder psychoeducational comparison condition previously tested (Olmsted et al., 2002) to control for expectancy effects and demand characteristics. To match the Diabetes Body Project, the educational lectures by Dr. Olmsted 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. | 0 | 25 | 0 | 25 | 0 | 25 |
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| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |