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NCT Number: NCT07468188

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.

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Key information

Conditions

Eating Disorders Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Feeding and Eating Disorders Glucose Metabolism Disorders Mental Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Type 2 Diabetes

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location status: Recruiting

Location contact

Christine Slyne

CONTACT

6173094683

Elena Toschi, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Body Project Type 2

Behavioral

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Change in Diabetes Eating Problems

    Time frame: baseline to 3 months

    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.

  2. Eating Disorder Diagnostic Interview (EDDI)

    Time frame: baseline to 3 months

    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.

  3. Change in Diabetes Distress

    Time frame: baseline to 3 months

    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.

  4. Change in Weight Bias

    Time frame: baseline to 3 month

    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.

Other outcomes

  1. Change in A1c

    Time frame: baseline to 3 months

    Change in A1c

  2. Change in CGM-derived time in range (TIR)

    Time frame: Baseline to 3 months

    Change in CGM-derived time in range (TIR)

Study contacts

Contact information is provided by the study sponsor or research team.

Christine Slyne

CONTACT

[email protected]

6173094683

Molly Savory

CONTACT

[email protected]

6173091997

Sponsors and collaborators

Lead sponsor

Joslin Diabetes Center

Other

Registry information

Official study title

Development of a T2D-Specific, Virtually-Delivered Disordered Eating Prevention Intervention - Diabetes Body Project 2

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 12, 2026
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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