Eating Disorders, Type 1 Diabetes
Conditions
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.
Interventions
BEHAVIORALDiabetes 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.
BEHAVIORALEducational 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.
Sponsors
Stanford University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 30 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Time With Blood Sugar in Range as a Measure of Glycemic Control | Three months following the 6-week intervention period | 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. |
| Eating Disorder Symptoms | Assessed at week 6 (post-intervention) and three months following the 6-week intervention period | 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. |
| Body Dissatisfaction (BS) | Week 6 (post-intervention) and three months following the 6-week intervention period | 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. |
| Thin Ideal Internalization | Week 6 (post-intervention) and three months following the 6-week intervention period | 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. |
| Diabetes-Specific Eating Pathology | Week 6 (post-intervention) and three months following the 6-week intervention period | 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. |
| Diabetes-Specific Distress | Week 6 (post-intervention) and three months following the 6-week intervention period | 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. |
| Negative Affect | Week 6 (post-intervention) and three months following the 6-week intervention period | 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. |
| Quality of Life (Well-Being) | Week 6 (post-intervention) and three months following the 6-week intervention period | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREric Stice, PhD
Stanford University
PRINCIPAL_INVESTIGATORKorey Hood, MDPhD
Stanford University
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| 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. | 25 |
| Total | 55 |
Baseline characteristics
| Characteristic | Diabetes Body Project | Total | Educational Control Group |
|---|---|---|---|
| Age, Categorical <=18 years | 3 Participants | 7 Participants | 4 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 48 Participants | 21 Participants |
| Body Dissatisfaction (BS) | 3.66 score on a scale STANDARD_DEVIATION 0.61 | 3.57 score on a scale STANDARD_DEVIATION 0.71 | 3.46 score on a scale STANDARD_DEVIATION 0.83 |
| Diabetes Distress | 2.44 score on a scale STANDARD_DEVIATION 0.82 | 2.44 score on a scale STANDARD_DEVIATION 0.9 | 2.44 score on a scale STANDARD_DEVIATION 1.01 |
| Diabetes eating pathology | 1.34 score on a scale STANDARD_DEVIATION 0.65 | 1.38 score on a scale STANDARD_DEVIATION 0.72 | 1.43 score on a scale STANDARD_DEVIATION 0.81 |
| Eating Disorder Symptoms | 12.83 composite score STANDARD_DEVIATION 8.65 | 14.27 composite score STANDARD_DEVIATION 13.73 | 16 composite score STANDARD_DEVIATION 18.12 |
| Education Associate's Degree | 2 Participants | 3 Participants | 1 Participants |
| Education Bachelor's Degree | 14 Participants | 21 Participants | 7 Participants |
| Education Did Not Disclose | 0 Participants | 1 Participants | 1 Participants |
| Education Grade School | 0 Participants | 1 Participants | 1 Participants |
| Education High School Degree/Equivalent | 1 Participants | 5 Participants | 4 Participants |
| Education Master's Degree | 4 Participants | 7 Participants | 3 Participants |
| Education Ph.D. or Higher | 2 Participants | 2 Participants | 0 Participants |
| Education Some College, no Degree | 4 Participants | 11 Participants | 7 Participants |
| Education Some High School | 3 Participants | 4 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 5 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 50 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Negative Affect | 2.15 score on a scale STANDARD_DEVIATION 0.73 | 2.25 score on a scale STANDARD_DEVIATION 0.81 | 2.38 score on a scale STANDARD_DEVIATION 0.89 |
| Percentage of Time With Blood Sugar in Range | .63 percentage of time STANDARD_DEVIATION 0.21 | 0.63 percentage of time STANDARD_DEVIATION 0.2 | .62 percentage of time STANDARD_DEVIATION 0.19 |
| Quality of Life | 2.33 score on a scale STANDARD_DEVIATION 0.99 | 2.21 score on a scale STANDARD_DEVIATION 0.99 | 2.07 score on a scale STANDARD_DEVIATION 0.99 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) White | 25 Participants | 43 Participants | 18 Participants |
| Region of Enrollment United States | 30 Participants | 55 Participants | 25 Participants |
| Sex: Female, Male Female | 30 Participants | 55 Participants | 25 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Thin-Ideal Internalization | 3.48 score on a scale STANDARD_DEVIATION 0.52 | 3.36 score on a scale STANDARD_DEVIATION 0.65 | 3.22 score on a scale STANDARD_DEVIATION 0.77 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 25 |
| other Total, other adverse events | 0 / 30 | 0 / 25 |
| serious Total, serious adverse events | 0 / 30 | 0 / 25 |
Outcome results
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.
Time frame: Week 6 (post-intervention) and three months following the 6-week intervention period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diabetes Body Project | Body Dissatisfaction (BS) | Post-Test (week 6) | 2.98 score on a scale | Standard Deviation 0.56 |
| Diabetes Body Project | Body Dissatisfaction (BS) | 3-Month Post-Test Follow Up | 3.09 score on a scale | Standard Deviation 0.71 |
| Educational Control Group | Body Dissatisfaction (BS) | Post-Test (week 6) | 3.46 score on a scale | Standard Deviation 0.5 |
| Educational Control Group | Body Dissatisfaction (BS) | 3-Month Post-Test Follow Up | 3.29 score on a scale | Standard Deviation 0.7 |
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.
Time frame: Week 6 (post-intervention) and three months following the 6-week intervention period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diabetes Body Project | Diabetes-Specific Distress | 3-Month Post-Test Follow Up | 1.92 score on a scale | Standard Deviation 0.96 |
| Diabetes Body Project | Diabetes-Specific Distress | Post-Test (week 6) | 1.81 score on a scale | Standard Deviation 0.88 |
| Educational Control Group | Diabetes-Specific Distress | 3-Month Post-Test Follow Up | 2.18 score on a scale | Standard Deviation 1.22 |
| Educational Control Group | Diabetes-Specific Distress | Post-Test (week 6) | 2.08 score on a scale | Standard Deviation 0.82 |
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.
Time frame: Week 6 (post-intervention) and three months following the 6-week intervention period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diabetes Body Project | Diabetes-Specific Eating Pathology | Post-Test (week 6) | 0.64 score on a scale | Standard Deviation 0.39 |
| Diabetes Body Project | Diabetes-Specific Eating Pathology | 3-Month Post-Test Follow Up | 0.70 score on a scale | Standard Deviation 0.48 |
| Educational Control Group | Diabetes-Specific Eating Pathology | 3-Month Post-Test Follow Up | 1.06 score on a scale | Standard Deviation 0.69 |
| Educational Control Group | Diabetes-Specific Eating Pathology | Post-Test (week 6) | 1.02 score on a scale | Standard Deviation 0.44 |
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.
Time frame: Assessed at week 6 (post-intervention) and three months following the 6-week intervention period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diabetes Body Project | Eating Disorder Symptoms | Post-Test (week 6) | 6.50 composite score | Standard Deviation 8.1 |
| Diabetes Body Project | Eating Disorder Symptoms | 3-Month Post-Test Follow Up | 5.82 composite score | Standard Deviation 7.14 |
| Educational Control Group | Eating Disorder Symptoms | Post-Test (week 6) | 11.87 composite score | Standard Deviation 12.42 |
| Educational Control Group | Eating Disorder Symptoms | 3-Month Post-Test Follow Up | 12.30 composite score | Standard Deviation 14 |
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.
Time frame: Week 6 (post-intervention) and three months following the 6-week intervention period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diabetes Body Project | Negative Affect | Post Test (week 6) | 1.79 score on a scale | Standard Deviation 0.77 |
| Diabetes Body Project | Negative Affect | 3-Month Post Test Follow Up | 1.95 score on a scale | Standard Deviation 0.79 |
| Educational Control Group | Negative Affect | Post Test (week 6) | 2.01 score on a scale | Standard Deviation 0.64 |
| Educational Control Group | Negative Affect | 3-Month Post Test Follow Up | 2.34 score on a scale | Standard Deviation 1.09 |
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.
Time frame: Three months following the 6-week intervention period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetes Body Project | Percentage of Time With Blood Sugar in Range as a Measure of Glycemic Control | 0.61 percentage of time | Standard Deviation 0.2 |
| Educational Control Group | Percentage of Time With Blood Sugar in Range as a Measure of Glycemic Control | 0.63 percentage of time | Standard Deviation 0.21 |
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.
Time frame: Week 6 (post-intervention) and three months following the 6-week intervention period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diabetes Body Project | Quality of Life (Well-Being) | Post-Test (week 6) | 2.94 score on a scale | Standard Deviation 0.91 |
| Diabetes Body Project | Quality of Life (Well-Being) | 3-Month Post-Test Follow Up | 2.75 score on a scale | Standard Deviation 0.99 |
| Educational Control Group | Quality of Life (Well-Being) | Post-Test (week 6) | 2.55 score on a scale | Standard Deviation 0.88 |
| Educational Control Group | Quality of Life (Well-Being) | 3-Month Post-Test Follow Up | 2.17 score on a scale | Standard Deviation 0.93 |
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.
Time frame: Week 6 (post-intervention) and three months following the 6-week intervention period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diabetes Body Project | Thin Ideal Internalization | Post-Test (week 6) | 2.92 score on a scale | Standard Deviation 0.75 |
| Diabetes Body Project | Thin Ideal Internalization | 3-Month Post-Test Follow-Up | 3.12 score on a scale | Standard Deviation 0.71 |
| Educational Control Group | Thin Ideal Internalization | Post-Test (week 6) | 3.15 score on a scale | Standard Deviation 0.66 |
| Educational Control Group | Thin Ideal Internalization | 3-Month Post-Test Follow-Up | 3.10 score on a scale | Standard Deviation 0.65 |