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Recruiting NCT07468188

Diabetes Body Project 2

No phase Interventional Eating Disorders Type 2 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Body Project Type 2.
Who it may be relevant to
Registry conditions: Eating Disorders, Type 2 Diabetes. Basic parameters: 18 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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 a

Primary outcome measures

  • Intervention refinement [Time frame: 6 months]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Joslin Diabetes Center — Boston

Identifiers

NCT: NCT07468188 · Study294

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗