NCT07468188

Brief 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). 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress65%
Jan 2025May 2027

Study Start

First participant enrolled

January 24, 2025

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 30, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

2.1 years

First QC Date

January 30, 2026

Last Update Submit

March 11, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in Diabetes Eating Problems

    baseline to 3 months

  • Eating Disorder Diagnostic Interview (EDDI)

    baseline to 3 months

  • Change in Diabetes Distress

    baseline to 3 months

  • Change in Weight Bias

    baseline to 3 month

Other Outcomes (2)

  • Change in A1c

    baseline to 3 months

  • Change in CGM-derived time in range (TIR)

    Baseline to 3 months

Study Arms (1)

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.

Behavioral: Body Project Type 2

Interventions

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.

Body Project Type 2 Intervention

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsenrolling young women due to the nature of the body image issues
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ) 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Feeding and Eating DisordersDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2026

First Posted

March 12, 2026

Study Start

January 24, 2025

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

May 31, 2027

Last Updated

March 12, 2026

Record last verified: 2026-03

Locations