Eating DisordersNCT07468188
Diabetes Body Project 2
A study testing Body Project Type 2 in people with Eating Disorders and Type 2 Diabetes, run by Joslin Diabetes Center at 1 site in United States.
Trial summary
The purpose of this study is to test the feasibility and effectiveness of an eating disorder prevention program specifically targeted for women with type 2 diabetes (T2D) called the Diabetes Body Project 2 (DBP2). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Eating Disorders, Type 2 Diabetes
- What is being tested?
- Body Project Type 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2025to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 1.) Female sex 2) self-reported gender identity of "woman"; 3) age 18-40 years old; 4) diagnosed with T2D for at least 6 months; 5) experiencing at least one body image concern.
Who cannot join
- Recent hospitalization for eating disorder within the last 12 months
- Eating disorder related diabetic ketoacidosis within the last 12 months
- unwillingness to be video-recorded,
- restricted English proficiency
- developmental, cognitive, or psychiatric limitations that compromise participation in the intervention sessions and study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Joslin Diabetes Center
Boston, Massachusetts, 02215
Christine Slyne, 6173094683
Elena Toschi, MD
About this study
Official title: Development of a T2D-Specific, Virtually-Delivered Disordered Eating Prevention Intervention - Diabetes Body Project 2
The purpose of this study is to test the feasibility and effectiveness of an eating disorder prevention program specifically targeted for women with type 2 diabetes (T2D) called the Diabetes Body Project 2 (DBP2).
The Diabetes Body Project 2 (DBP2) will be adapted from the Diabetes Body Project, which is an eating disorder prevention program developed to improve satisfaction with body image and diabetes management for young women with type 1 diabetes (DBP).
The study is looking to see if the DBP is effective in improving body image concerns, reducing disordered eating behaviors and improving glycemic control in women with T2D.
- Conditions
- Eating Disorders, Type 2 Diabetes
- Being tested
- Body Project Type 2
- Medical subject headings
- Feeding and Eating Disorders, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body Project Type 2Behavioural
This program consists of weekly 1-hour sessions for 6 weeks, co-led by 2 facilitators. Each session has home exercises. Home exercises are discussed at each session. session 1, collectively define the thin appearance ideal, discuss costs of pursuing this ideal. session 2 dissuade facilitators from pursuing the thin ideal in role-plays. session 3, conduct role-plays challenging thin-ideal statements, discuss personal body image concerns. session 4, the negative effects of social comparison, the advantages and costs of social media. session 5, strategies of living well with diabetes and maintaining good self-care, as well as the physiological and psychological advantages of insulin. session 6 discuss the benefits of the group and what was learned and how to continue some of the exercises introduced in the Diabetes Body Project; participants are encouraged to engage in at least one more self-affirmation exercise and email the facilitators to tell them how it went.
| Study group | Role | What they receive |
|---|---|---|
| Body Project Type 2 Intervention | Experimental | This program consists of weekly 1-hour sessions for 6 weeks, co-led by 2 facilitators. Each session has home exercises. Home exercises are discussed at each session. session 1, collectively define the thin appearance ideal, discuss costs of pursuing this ideal. session 2 dissuade facilitators from pursuing the thin ideal in role-plays. session 3, conduct role-plays challenging thin-ideal statements, discuss personal body image concerns. session 4, the negative effects of social comparison, the advantages and costs of social media. session 5, strategies of living well with diabetes and maintaining good self-care, as well as the physiological and psychological advantages of insulin. session 6 discuss the benefits of the group and what was learned and how to continue some of the exercises introduced in the Diabetes Body Project; participants are encouraged to engage in at least one more self-affirmation exercise and email the facilitators to tell them how it went. Receives: Behavioral: Body Project Type 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention refinement
Development and refinement of diabetes body project intervention script "DBP2" for young women with type 2 diabetes and body image concern
Measured: 6 months
Secondary outcomes (4)
Change in Diabetes Eating Problems
Assess change in score of Diabetes Eating Problem Survey-Revised (DEPS-R). 16-question assessment that evaluates eating and diabetes management over a one month period. Each question is scored on the following scale: 0 (never), 1 (rarely), 2 (sometimes), 3 (often), 4 (usually) to 5 (always). Higher scores indicate more disordered eating.
Measured: baseline to 3 months
Eating Disorder Diagnostic Interview (EDDI)
Participants will complete the Eating Disorder Diagnostic Interview (EDDI) over the phone with the research team. This semi-structured interview is used to assess eating disordered patterns for woman with type 2 diabetes over a year-long period. The interview has 24 questions, each with a unique scoring scale, which is assessed individually by question.
Measured: baseline to 3 months
Change in Diabetes Distress
Assess change in score of Type 2 Diabetes Distress Assessment Scale (T2-DDAS). 29-question assessment that evaluates the stresses and worries of those with type 2 diabetes over a one month period. Each question is scored on the following scale: 1 (not a problem), 2 (a little problem), 3(a moderate problem), 4 (a serious problem), to 5 (a very serious problem). For the first 8 questions, the higher the score the higher intensity of distress. For questions 9-29, scoring is divided into categories to assess sources of distress (hypoglycemia, long-term health, healthcare providers, interpersonal issues, shame/stigma, healthcare access, and management demands). The higher the score per source, the higher the impact of distress on that source.
Measured: baseline to 3 months
Change in Weight Bias
Assess change in score of Weight Bias Internalization Scale (WBIS). 11-item assessment that evaluates perceived weight status at time of survey. Each question is scored on the following scale: 1 (strongly disagree), 2 (disagree), 3 (slightly disagree), 4 (neutral), 4 (usually), 5 (slightly agree), 6 (agree), to 7 (strongly agree). Higher scores indicate more internalized weight bias.
Measured: baseline to 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start24 Jan 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468188
- Sponsor's protocol ID
- Study294
- Status last verified
- Mar 2026
- First submitted
- 30 Jan 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a T2D-Specific, Virtually-Delivered Disordered Eating Prevention Intervention - Diabetes Body Project 2
- ClinicalTrials.gov ID
- NCT07468188
- Acronym / sponsor ID
- Study294
- Conditions
- Eating Disorders, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Study start
- 24 Jan 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the feasibility and effectiveness of an eating disorder prevention program specifically targeted for women with type 2 diabetes (T2D) called the Diabetes Body Project 2 (DBP2).
The Diabetes Body Project 2 (DBP2) will be adapted from the Diabetes Body Project, which is an eating disorder prevention program developed to improve satisfaction with body image and diabetes management for young women with type 1 diabetes (DBP).
The study is looking to see if the DBP is effective in improving body image concerns, reducing disordered eating behaviors and improving glycemic control in women with T2D.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Body Project Type 2 Intervention | Experimental | Behavioral: Body Project Type 2This program consists of weekly 1-hour sessions for 6 weeks, co-led by 2 facilitators. Each session has home exercises. Home exercises are discussed at each session. session 1, collectively define the thin appearance ideal, discuss costs of pursuing this ideal. session 2 dissuade facilitators from pursuing the thin ideal in role-plays. session 3, conduct role-plays challenging thin-ideal statements, discuss personal body image concerns. session 4, the negative effects of social comparison, the advantages and costs of social media. session 5, strategies of living well with diabetes and maintaining good self-care, as well as the physiological and psychological advantages of insulin. session 6 discuss the benefits of the group and what was learned and how to continue some of the exercises introduced in the Diabetes Body Project; participants are encouraged to engage in at least one more self-affirmation exercise and email the facilitators to tell them how it went. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1.) Female sex 2) self-reported gender identity of "woman"; 3) age 18-40 years old; 4) diagnosed with T2D for at least 6 months; 5) experiencing at least one body image concern.
Key exclusion criteria (5 listed)
- Recent hospitalization for eating disorder within the last 12 months
- Eating disorder related diabetic ketoacidosis within the last 12 months
- unwillingness to be video-recorded,
- restricted English proficiency
- developmental, cognitive, or psychiatric limitations that compromise participation in the intervention sessions and study.
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 |
|---|---|---|
| Body Project Type 2This program consists of weekly 1-hour sessions for 6 weeks, co-led by 2 facilitators. Each session has home exercises. Home exercises are discussed at each session. session 1, collectively define the thin appearance ideal, discuss costs of pursuing this ideal. session 2 dissuade facilitators from pursuing the thin ideal in role-plays. session 3, conduct role-plays challenging thin-ideal statements, discuss personal body image concerns. session 4, the negative effects of social comparison, the advantages and costs of social media. session 5, strategies of living well with diabetes and maintaining good self-care, as well as the physiological and psychological advantages of insulin. session 6 discuss the benefits of the group and what was learned and how to continue some of the exercises introduced in the Diabetes Body Project; participants are encouraged to engage in at least one more self-affirmation exercise and email the facilitators to tell them how it went. | Behavioural | Body Project Type 2 Intervention |
Primary outcome
Intervention refinement
Time frame: 6 months
Development and refinement of diabetes body project intervention script "DBP2" for young women with type 2 diabetes and body image concern
4 secondary outcomes
Change in Diabetes Eating Problems
Time frame: baseline to 3 months
Eating Disorder Diagnostic Interview (EDDI)
Time frame: baseline to 3 months
Change in Diabetes Distress
Time frame: baseline to 3 months
Change in Weight Bias
Time frame: baseline to 3 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body Project Type 2 in people with Eating Disorders and Type 2 Diabetes, run by Joslin Diabetes Center 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 5 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: looking for participants now, as of the sponsor's last update on 12 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christine Slyne (6173094683, christine.slyne@joslin.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention refinement (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2026.