Eating DisordersNCT05264376

Eating Disorder Prevention Program for Women With T1D

A study testing Diabetes Body Project in people with Eating Disorders and Type 1 Diabetes, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 15 to 30 years, women only
Conditions the study is for: Eating Disorders, Type 1 Diabetes
What is being tested?: Diabetes Body Project
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 55 participants
Where: 1 siteUnited States
Study dates: 21 Mar 2022to 15 Apr 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 to 30 years
Women only
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University
Stanford, California, 94305

Other trials in United States

About this study

Official title: Evaluating an Eating Disorder Prevention Program for Young Women With Type 1 Diabetes

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.

Conditions: Eating Disorders, Type 1 Diabetes
Being tested: Diabetes Body Project, Educational Control
Medical subject headings: Feeding and Eating Disorders, Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Diabetes Body ProjectBehavioural
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 ControlBehavioural
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.

Study groups in NCT05264376
Study group	Role	What they receive
Diabetes Body Project	Experimental	Not described Receives: Behavioral: Diabetes Body Project
Educational Control Group	Active comparator	Not described Receives: Behavioral: Educational Control

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 6 (post-intervention) and three months following the 6-week intervention period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Mar 202215 Apr 2023

First posted3 Mar 2022
Study start21 Mar 2022
Primary completion15 Apr 2023
Study completion15 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Eating DisordersStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: Single blind
Who is masked: Investigator
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05264376
Sponsor's protocol ID: 63675
Other IDs: P30DK116074
Status last verified: Dec 2024
First submitted: 17 Feb 2022
Last updated: 14 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 27709979
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.
PubMed 20032278
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.
PubMed 25765489
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.
PubMed 3397865
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.
PubMed 17475940
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.
PubMed 37951479

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Eating Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating an Eating Disorder Prevention Program for Young Women With Type 1 Diabetes
ClinicalTrials.gov ID: NCT05264376
Acronym / sponsor ID: 63675
Conditions: Eating Disorders, Type 1 Diabetes
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 21 Mar 2022 (actual)
Primary completion: 15 Apr 2023 (actual)
Study completion: 15 Apr 2023 (actual)
First posted: 3 Mar 2022 (actual)
Results: Posted 7 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2
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.

Arm	Type	Receives
Diabetes Body Project	Experimental	Behavioral: Diabetes Body Project
Educational Control Group	Active comparator	Behavioral: Educational Control

Who may qualify

Ages: 15 to 30 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Diabetes Body ProjectThe 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.	Behavioural	Diabetes Body Project
Educational ControlWe 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.	Behavioural	Educational Control Group

Primary outcome

Percentage of Time With Blood Sugar in Range as a Measure of Glycemic Control
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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.

Results and safety

Results posted to the registry on 7 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Diabetes Body Project	30	30
Educational Control Group	25	25

Primary outcome: Percentage of Time With Blood Sugar in Range as a Measure of Glycemic Control

Time frame: Three months following the 6-week intervention period. Mean (Standard Deviation). Unit: percentage of time

Measure	Diabetes Body Project n = 30	Educational Control Group n = 25
Value	0.61 (0.20)	0.63 (0.21)

Primary outcome: Eating Disorder Symptoms

Time frame: Assessed at week 6 (post-intervention) and three months following the 6-week intervention period. Mean (Standard Deviation). Unit: composite score

Measure	Diabetes Body Project n = 30	Educational Control Group n = 25
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)

Primary outcome: Body Dissatisfaction (BS)

Time frame: Week 6 (post-intervention) and three months following the 6-week intervention period. Mean (Standard Deviation). Unit: score on a scale

Measure	Diabetes Body Project n = 30	Educational Control Group n = 25
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)

Primary outcome: Thin Ideal Internalization

Time frame: Week 6 (post-intervention) and three months following the 6-week intervention period. Mean (Standard Deviation). Unit: score on a scale

Measure	Diabetes Body Project n = 30	Educational Control Group n = 25
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)

Adverse events

Time frame: 6-week intervention period plus 3-month follow-up period. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Diabetes Body Project	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Educational Control Group	0 of 25 (0%)	0 of 25 (0%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27709979Stice 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.
Background: PubMed 20032278Markowitz 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.
Background: PubMed 25765489Fisher 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.
Background: PubMed 3397865Watson 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.
Background: PubMed 17475940de 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.
Results publication: PubMed 37951479Stice 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Eric Stice, PhD principal investigator

Stanford University

Korey Hood, MDPhD principal investigator

Stanford University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Diabetes Body Project in people with Eating Disorders and Type 1 Diabetes, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Time With Blood Sugar in Range as a Measure of Glycemic Control (time frame: Three months following the 6-week intervention period). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05264376, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.