An interventional study of Diabetes Body Project and Educational Control in Eating Disorders and Type 1 Diabetes, sponsored by Stanford University. Completed at 1 site in United States. Open to female participants aged 15 Years to 30 Years. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Stanford University · Not applicable, Interventional, and Prevention
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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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
Behavioral: Diabetes Body Project
Behavioral: Educational Control
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 6 (post-intervention) and three months following the 6-week intervention period
| Milestone | Diabetes Body Project | Educational Control Group |
|---|---|---|
| Started | 30 | 25 |
| Completed | 30 | 25 |
| Not completed | 0 | 0 |
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.
| percentage of time | Diabetes Body Project | Educational Control Group |
|---|---|---|
| Percentage of Time With Blood Sugar in Range as a Measure of Glycemic Control | 0.61 ± 0.20 | 0.63 ± 0.21 |
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.
| composite score | Diabetes Body Project | Educational Control Group |
|---|---|---|
| Post-Test (week 6) | 6.50 ± 8.10 | 11.87 ± 12.42 |
| 3-Month Post-Test Follow Up | 5.82 ± 7.14 | 12.30 ± 14.00 |
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.
| score on a scale | Diabetes Body Project | Educational Control Group |
|---|---|---|
| Post-Test (week 6) | 2.98 ± 0.56 | 3.46 ± 0.50 |
| 3-Month Post-Test Follow Up | 3.09 ± 0.71 | 3.29 ± 0.70 |
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.
| score on a scale | Diabetes Body Project | Educational Control Group |
|---|---|---|
| Post-Test (week 6) | 2.92 ± 0.75 | 3.15 ± 0.66 |
| 3-Month Post-Test Follow-Up | 3.12 ± 0.71 | 3.10 ± 0.65 |
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.
| score on a scale | Diabetes Body Project | Educational Control Group |
|---|---|---|
| Post-Test (week 6) | 0.64 ± 0.39 | 1.02 ± 0.44 |
| 3-Month Post-Test Follow Up | 0.70 ± 0.48 | 1.06 ± 0.69 |
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.
| score on a scale | Diabetes Body Project | Educational Control Group |
|---|---|---|
| Post-Test (week 6) | 1.81 ± 0.88 | 2.08 ± 0.82 |
| 3-Month Post-Test Follow Up | 1.92 ± 0.96 | 2.18 ± 1.22 |
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.
| score on a scale | Diabetes Body Project | Educational Control Group |
|---|---|---|
| Post Test (week 6) | 1.79 ± 0.77 | 2.01 ± 0.64 |
| 3-Month Post Test Follow Up | 1.95 ± 0.79 | 2.34 ± 1.09 |
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.
| score on a scale | Diabetes Body Project | Educational Control Group |
|---|---|---|
| Post-Test (week 6) | 2.94 ± 0.91 | 2.55 ± 0.88 |
| 3-Month Post-Test Follow Up | 2.75 ± 0.99 | 2.17 ± 0.93 |
Collected over 6-week intervention period plus 3-month follow-up period. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Diabetes Body Project | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Educational Control Group | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Age, Categorical(Participants) | Diabetes Body Project | Educational Control Group | Total |
|---|---|---|---|
| <=18 years | 3 | 4 | 7 |
| Between 18 and 65 years | 27 | 21 | 48 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Diabetes Body Project | Educational Control Group | Total |
|---|---|---|---|
| Female | 30 | 25 | 55 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Diabetes Body Project | Educational Control Group | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 3 | 5 |
| Not Hispanic or Latino | 28 | 22 | 50 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Diabetes Body Project | Educational Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 3 | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 25 | 18 | 43 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 3 | 3 |
| Region of Enrollment(Participants) | Diabetes Body Project | Educational Control Group | Total |
|---|---|---|---|
| United States | 30 | 25 | 55 |
| Thin-Ideal Internalization(score on a scale) | Diabetes Body Project | Educational Control Group | Total |
|---|---|---|---|
| Mean | 3.48 ± .52 | 3.22 ± .77 | 3.36 ± 0.65 |
| Body Dissatisfaction (BS)(score on a scale) | Diabetes Body Project | Educational Control Group | Total |
|---|---|---|---|
| Mean | 3.66 ± .61 | 3.46 ± .83 | 3.57 ± 0.71 |
| Negative Affect(score on a scale) | Diabetes Body Project | Educational Control Group | Total |
|---|---|---|---|
| Mean | 2.15 ± .73 | 2.38 ± .89 | 2.25 ± 0.81 |
6 further baseline measures are reported on the registry.
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