Trial Outcomes & Findings for Eating Disorder Prevention Program for Women With T1D (NCT NCT05264376)
NCT ID: NCT05264376
Last Updated: 2025-01-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
55 participants
Primary outcome timeframe
Three months following the 6-week intervention period
Results posted on
2025-01-07
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
25
|
|
Overall Study
COMPLETED
|
30
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Eating Disorder Prevention Program for Women With T1D
Baseline characteristics by cohort
| Measure |
Diabetes Body Project
n=30 Participants
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.
|
Educational Control Group
n=25 Participants
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.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Thin-Ideal Internalization
|
3.48 score on a scale
STANDARD_DEVIATION .52 • n=5 Participants
|
3.22 score on a scale
STANDARD_DEVIATION .77 • n=7 Participants
|
3.36 score on a scale
STANDARD_DEVIATION 0.65 • n=5 Participants
|
|
Body Dissatisfaction (BS)
|
3.66 score on a scale
STANDARD_DEVIATION .61 • n=5 Participants
|
3.46 score on a scale
STANDARD_DEVIATION .83 • n=7 Participants
|
3.57 score on a scale
STANDARD_DEVIATION 0.71 • n=5 Participants
|
|
Negative Affect
|
2.15 score on a scale
STANDARD_DEVIATION .73 • n=5 Participants
|
2.38 score on a scale
STANDARD_DEVIATION .89 • n=7 Participants
|
2.25 score on a scale
STANDARD_DEVIATION 0.81 • n=5 Participants
|
|
Eating Disorder Symptoms
|
12.83 composite score
STANDARD_DEVIATION 8.65 • n=5 Participants
|
16 composite score
STANDARD_DEVIATION 18.12 • n=7 Participants
|
14.27 composite score
STANDARD_DEVIATION 13.73 • n=5 Participants
|
|
Diabetes eating pathology
|
1.34 score on a scale
STANDARD_DEVIATION .65 • n=5 Participants
|
1.43 score on a scale
STANDARD_DEVIATION .81 • n=7 Participants
|
1.38 score on a scale
STANDARD_DEVIATION 0.72 • n=5 Participants
|
|
Diabetes Distress
|
2.44 score on a scale
STANDARD_DEVIATION .82 • n=5 Participants
|
2.44 score on a scale
STANDARD_DEVIATION 1.01 • n=7 Participants
|
2.44 score on a scale
STANDARD_DEVIATION 0.9 • n=5 Participants
|
|
Quality of Life
|
2.33 score on a scale
STANDARD_DEVIATION .99 • n=5 Participants
|
2.07 score on a scale
STANDARD_DEVIATION .99 • n=7 Participants
|
2.21 score on a scale
STANDARD_DEVIATION 0.99 • n=5 Participants
|
|
Percentage of Time With Blood Sugar in Range
|
.63 percentage of time
STANDARD_DEVIATION .21 • n=5 Participants
|
.62 percentage of time
STANDARD_DEVIATION .19 • n=7 Participants
|
0.63 percentage of time
STANDARD_DEVIATION 0.20 • n=5 Participants
|
|
Education
Grade School
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Education
Some High School
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Education
High School Degree/Equivalent
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Education
Some College, no Degree
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Education
Associate's Degree
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Education
Bachelor's Degree
|
14 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Education
Master's Degree
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Education
Ph.D. or Higher
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Education
Did Not Disclose
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Three months following the 6-week intervention periodParticipants 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.
Outcome measures
| Measure |
Diabetes Body Project
n=30 Participants
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.
|
Educational Control Group
n=25 Participants
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.
|
|---|---|---|
|
Percentage of Time With Blood Sugar in Range as a Measure of Glycemic Control
|
0.61 percentage of time
Standard Deviation 0.20
|
0.63 percentage of time
Standard Deviation 0.21
|
PRIMARY outcome
Timeframe: Assessed at week 6 (post-intervention) and three months following the 6-week intervention periodParticipants 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.
Outcome measures
| Measure |
Diabetes Body Project
n=30 Participants
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.
|
Educational Control Group
n=25 Participants
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.
|
|---|---|---|
|
Eating Disorder Symptoms
Post-Test (week 6)
|
6.50 composite score
Standard Deviation 8.10
|
11.87 composite score
Standard Deviation 12.42
|
|
Eating Disorder Symptoms
3-Month Post-Test Follow Up
|
5.82 composite score
Standard Deviation 7.14
|
12.30 composite score
Standard Deviation 14.00
|
PRIMARY outcome
Timeframe: Week 6 (post-intervention) and three months following the 6-week intervention periodAssessed 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.
Outcome measures
| Measure |
Diabetes Body Project
n=30 Participants
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.
|
Educational Control Group
n=25 Participants
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.
|
|---|---|---|
|
Body Dissatisfaction (BS)
Post-Test (week 6)
|
2.98 score on a scale
Standard Deviation 0.56
|
3.46 score on a scale
Standard Deviation 0.50
|
|
Body Dissatisfaction (BS)
3-Month Post-Test Follow Up
|
3.09 score on a scale
Standard Deviation 0.71
|
3.29 score on a scale
Standard Deviation 0.70
|
PRIMARY outcome
Timeframe: Week 6 (post-intervention) and three months following the 6-week intervention periodAssessed 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.
Outcome measures
| Measure |
Diabetes Body Project
n=30 Participants
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.
|
Educational Control Group
n=25 Participants
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.
|
|---|---|---|
|
Thin Ideal Internalization
Post-Test (week 6)
|
2.92 score on a scale
Standard Deviation 0.75
|
3.15 score on a scale
Standard Deviation 0.66
|
|
Thin Ideal Internalization
3-Month Post-Test Follow-Up
|
3.12 score on a scale
Standard Deviation 0.71
|
3.10 score on a scale
Standard Deviation 0.65
|
PRIMARY outcome
Timeframe: Week 6 (post-intervention) and three months following the 6-week intervention periodAssessed 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.
Outcome measures
| Measure |
Diabetes Body Project
n=30 Participants
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.
|
Educational Control Group
n=25 Participants
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.
|
|---|---|---|
|
Diabetes-Specific Eating Pathology
Post-Test (week 6)
|
0.64 score on a scale
Standard Deviation 0.39
|
1.02 score on a scale
Standard Deviation 0.44
|
|
Diabetes-Specific Eating Pathology
3-Month Post-Test Follow Up
|
0.70 score on a scale
Standard Deviation 0.48
|
1.06 score on a scale
Standard Deviation 0.69
|
PRIMARY outcome
Timeframe: Week 6 (post-intervention) and three months following the 6-week intervention periodAssessed 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.
Outcome measures
| Measure |
Diabetes Body Project
n=30 Participants
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.
|
Educational Control Group
n=25 Participants
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.
|
|---|---|---|
|
Diabetes-Specific Distress
Post-Test (week 6)
|
1.81 score on a scale
Standard Deviation 0.88
|
2.08 score on a scale
Standard Deviation 0.82
|
|
Diabetes-Specific Distress
3-Month Post-Test Follow Up
|
1.92 score on a scale
Standard Deviation 0.96
|
2.18 score on a scale
Standard Deviation 1.22
|
PRIMARY outcome
Timeframe: Week 6 (post-intervention) and three months following the 6-week intervention periodNegative 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.
Outcome measures
| Measure |
Diabetes Body Project
n=30 Participants
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.
|
Educational Control Group
n=25 Participants
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.
|
|---|---|---|
|
Negative Affect
Post Test (week 6)
|
1.79 score on a scale
Standard Deviation 0.77
|
2.01 score on a scale
Standard Deviation 0.64
|
|
Negative Affect
3-Month Post Test Follow Up
|
1.95 score on a scale
Standard Deviation 0.79
|
2.34 score on a scale
Standard Deviation 1.09
|
PRIMARY outcome
Timeframe: Week 6 (post-intervention) and three months following the 6-week intervention periodAssessed 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.
Outcome measures
| Measure |
Diabetes Body Project
n=30 Participants
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.
|
Educational Control Group
n=25 Participants
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.
|
|---|---|---|
|
Quality of Life (Well-Being)
Post-Test (week 6)
|
2.94 score on a scale
Standard Deviation 0.91
|
2.55 score on a scale
Standard Deviation 0.88
|
|
Quality of Life (Well-Being)
3-Month Post-Test Follow Up
|
2.75 score on a scale
Standard Deviation 0.99
|
2.17 score on a scale
Standard Deviation 0.93
|
Adverse Events
Diabetes Body Project
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Educational Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place