Diabetes Body Project 2

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes; Eating Disorders
• Intervention / Treatment: Behavioral: Body Project Type 2

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christine Slyne; Phone Number: 6173094683; Email: christine.slyne@joslin.harvard.edu
• Study Contact Backup: Name: Molly Savory; Phone Number: 6173091997; Email: msavory1@joslin.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Joslin Diabetes Center
      • Principal Investigator: Elena Toschi, MD
      • Contact: Christine Slyne; Phone Number: 6173094683

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Body Project Type 2 Intervention; 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.

Behavioral: Body Project Type 2; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention refinement	Development and refinement of diabetes body project intervention script "DBP2" for young women with type 2 diabetes and body image concern	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	baseline to 3 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in A1c	Change in A1c	baseline to 3 months
Change in CGM-derived time in range (TIR)	Change in CGM-derived time in range (TIR)	Baseline to 3 months

Collaborators and Investigators

• Sponsor: Joslin Diabetes Center

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: January 30, 2026
• First Submitted That Met QC Criteria: March 11, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Mental Disorders; Metabolic Diseases; Signs and Symptoms, Digestive; Glucose Metabolism Disorders; Diabetes Mellitus; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Diabetes Mellitus, Type 2; Feeding and Eating Disorders
• Other Study ID Numbers: Study294

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No