Eating Disorder Prevention Program for Women With T1D

Type 1 Diabetes Clinical Trial

Official title:

Evaluating an Eating Disorder Prevention Program for Young Women With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05264376
• Other study ID #: 63675
• Status: Completed
• Phase: N/A
• Start date: March 21, 2022
• Est. completion date: April 15, 2023

Study information

• Verified date: May 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to test the effectiveness of an evidence-based eating- disorder prevention program specifically targeted for individuals with Type 1 Diabetes (T1D) compared to an educational control group. The Diabetes Body Project (DBP), is an adaptation of the Body Project which is the only eating disorder prevention program to have repeatedly produced effects when evaluated by independent researchers, produced stronger effects than credible alternative interventions, and affected objective outcomes. DBP has been adapted slightly for individuals with T1D who are at ultra-high risk for eating disorders. The study aims to test the effectiveness of the DBP of reducing body image concerns and reducing eating pathology and improving glycemic control.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: April 15, 2023
• Est. primary completion date: April 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 30 Years

Eligibility

Inclusion Criteria:

I)female-identifying II) aged 15-30 years old III) diagnosis of T1D for at least a 6-month duration per American Diabetes Association(ADA) criteria who are taking insulin IV) have visited their diabetes care provider in the past year V) body image concerns Exclusion Criteria: I) not female identifying II) not in age range III) does not have a diagnosis of T1D for at least 6 months per ADA criteria who are taking insulin IV) have not visited their diabetes care provider in the past year V) do not report some level of body dissatisfaction

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Eating Disorders
• Feeding and Eating Disorders
• Type 1 Diabetes

Intervention

Behavioral:
• Diabetes Body Project
The Diabetes Body Project (DBP) is an adapted version of the Body Project Prevention program designed specifically for individuals with Type 1 Diabetes. DBP consists of six weekly, one-hour long sessions. Group participants complete the exercises from the original Body Project and also new diabetes-specific content, drawn from Olmsted et al. (2002) that is delivered in a dissonance-based interactive format with Socratic questions from group leaders encourage participants to generate their own answers.
• Educational Control
We selected a T1D management/Eating disorder psychoeducational comparison condition previously tested (Olmsted et al., 2002) to control for expectancy effects and demand characteristics. To match the Diabetes Body Project, the educational lectures by Dr. Olmsted will be delivered in 6 1-hour blocks. Topics include basic information about the various EDs, complications of ED behaviors, diabetes and body image, effects of dieting on blood glucose, and the risk of complications.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change over time Glycemic Control	Participants will wear a continuous-glucose monitor for 14 days as well as self-report A1c levels	Pre intervention obtained on intake and 3 months after the conclusion of the intervention.
Primary	Change in Eating Disorder Symptoms	Participants will complete a diagnostic interview that is administered by a trained research assistant. We will be using the Eating Disorder Diagnostic Interview (EDDI). Scores are not reported on a scale. The research assistant who conducts the diagnostic interview at post-test and 3-month follow-up will be blinded to the person's condition.	pre intervention obtained on intake, immediately post intervention, and 3 months after the conclusion of the intervention
Primary	Change over time in Dieting	Assessed with the 10-item Dutch Restrained Eating Scale (DRES; van Strien et al., 1986) that measures dieting behaviors over the past month. Scores for each item range from 1 = Never to 5 = Always with higher scores indicating more frequent dieting behaviors.	pre intervention obtained on intake, immediately post intervention, and 3 months after the conclusion of the intervention
Primary	Change over time in Body Dissatisfaction	Assessed with the 10-item Body Dissatisfaction Scale (BDI; Berscheid et al., 2973) which assesses dissatisfaction with various body parts. Each item is scored on a scale of 1 = extremely dissatisfied to 5 = extremely satisfied. Lower scores indicate greater body dissatisfaction.	pre intervention obtained on intake, immediately post intervention, and 3-months after the conclusion of the intervention
Primary	Change over time in Ideal Body Beliefs	Assessed with the 8-item Ideal-Body Stereotype Scale-Revised (Stice et al., 2017) which measures pursuit of the thin ideal. Each item is scored on a scale of 1 = strongly disagree to 5 = strongly agree. Higher scores indicate greater belief in the thin-deal.	pre intervention obtained on intake, immediately post intervention, and 3 months after the conclusion of the intervention
Primary	Change over time in Diabetes-Specific Eating Pathology	Assessed with the 16-item Diabetes Eating Problem Survey-Revised (DEPS-R; Markowitz et al,.2010). Each item is assessed on a scale of 0 = Never to 5= Always. Higher scores indicate greater eating pathology specific to individuals with Type 1 Diabetes such as purposefully not taking enough insulin.	pre intervention obtained on intake, immediately post intervention, and 3 months after the conclusion of the intervention
Primary	Change over time in Diabetes-Specific Distress	Assessed with the 28-item Type 1 Diabetes Distress Scale (DDS; Fisher et al., 2015) which measures distress related to diabetes. Each item is assessed on a scale of 1 = Not a Problem to 6 = A Very Serious Problem. High scores indicate greater distress that are related to living with Type 1 Diabetes.	pre intervention obtained on intake, immediately post intervention, and 3 months after the conclusion of the intervention
Primary	Change over time in Negative Affect	Negative affect will be assessed with the sadness, guilt, and fear/anxiety subscales (totaling 20 items) from the Positive Affect and Negative Affect Scale-Revised (PANAS-X; Watson & Clark, 1992). Each item is scored on a scale of 1 = Not at All to 5 = Extremely. Higher scores indicate greater negative affect.	pre intervention obtained on intake, immediately post intervention, and 3 months after the conclusion of the intervention
Primary	Change over time in Perceived Well-Being as assessed by the World Health Organization Well-Being Index (WHO-5; deWit et al., 2007).	Assessed with the 5-item World Health Organization Well-Being Index (WHO-5; deWit et al., 2007) that measures health related quality of life. Each item is scored on a scale of 0 = At no Time to 5 = All of the Time. Higher scores indicate greater well-being	pre intervention obtained on intake, immediately post intervention, and 3 months after the conclusion of the intervention