Multi-Site Eating Disorder Prevention Program for Type 1 Diabetes
Primary Purpose
Type 1 Diabetes, Eating Disorders
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Diabetes Body Project
Educational Group
Sponsored by
About this trial
This is an interventional prevention trial for Type 1 Diabetes
Eligibility Criteria
Inclusion Criteria:
- between the ages of 14-35
- diagnosis of Type 1 Diabetes of at least 1 year
- using insulin
- experiencing at least some level of body image concerns
Exclusion Criteria:
- not between the ages of 14-35
- does not have access to wifi (will need for the virtual groups)
- Type 1 Diabetes diagnosis of less than 1 year
- does not live in the same time zone of Stanford (helps in coordinating groups)
- hospitalized for eating disorder treatment in the past year
- had eating-disorder related Diabetic Ketoacidosis (DKA) in the past year
- not using insulin
- not experiencing any level of body image concerns
- Unwilling to be video-recorded if assigned to Diabetes Body Project
- restricted proficiency in language that groups will be conducted in (dependent on location), and pervasive developmental, cognitive, or psychiatric limitations that compromise participation in the intervention sessions and study.
Sites / Locations
- Stanford UniversityRecruiting
- Joslin Diabetes CenterRecruiting
- Amsterdam Medical University CenterRecruiting
- Oslo University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Diabetes Body Project
Educational Group
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Change in Glycemic Control
Objectively assessed HbA1c (at clinic or by a self-test kit)
Change in Time-In-Range (TIR)
TIR past 14 days, screen shot of device. Time-Above-Range (TAR) and Time-Below-Range (TBR) are also recorded
Change in Health Care Utilization
service utilization will be assessed with an adapted version of the Patterns of Help Seeking Behavior Scale (Lane & Addis, 2005). Participants in both conditions will be asked to report frequency of care the past year for physical, mental health, eating, and weight problem
Change over time in Diabetes-Specific Distress
Assessed with the 20-item Problem Areas In Diabetes scale (PAID) which measures distress related to diabetes. High scores indicate greater distress that are related to living with Type 1 Diabetes
Change over time in Diabetes-Related Quality of Life
Assessed with the adolescent version (23 items) (Hilliard et al., 2020)and young adult version (27-items) of Type 1 Diabetes and Life (T1DAL) measures (Hilliard et al., 2021)assess diabetes specific health-related quality of life among participants with T1D. Total scores are transformed to a 0-100 scale and enables comparison of scores across age ranges. Higher scores indicate greater distress.
Full Information
NCT ID
NCT05399446
First Posted
May 26, 2022
Last Updated
June 27, 2023
Sponsor
Oslo University Hospital
Collaborators
Juvenile Diabetes Research Foundation, University of Minnesota, Joslin Diabetes Center, Stanford University, Amsterdam UMC, location VUmc
1. Study Identification
Unique Protocol Identification Number
NCT05399446
Brief Title
Multi-Site Eating Disorder Prevention Program for Type 1 Diabetes
Official Title
Multi-site Trial of a Virtually Delivered Eating Disorder Prevention Program for Young People With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
January 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Juvenile Diabetes Research Foundation, University of Minnesota, Joslin Diabetes Center, Stanford University, Amsterdam UMC, location VUmc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Eating Disorders
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
The assessor completing the interview at each follow-up assessment following completion of the intervention will be blinded to the condition the participant was in.
Allocation
Randomized
Enrollment
280 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diabetes Body Project
Arm Type
Experimental
Arm Title
Educational Group
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Diabetes Body Project
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Educational Group
Intervention Description
We selected a T1D management/Eating disorder psychoeducational comparison condition to control for expectancy effects and demand characteristics. To match the Diabetes Body Project, the educational lectures 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.
Primary Outcome Measure Information:
Title
Change over time in Ideal Body Beliefs
Description
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.
Time Frame
pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention]
Title
Change over time in Body Dissatisfaction
Description
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.
Time Frame
pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention]
Title
Change over time in Diabetes-Specific Eating Pathology
Description
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.
Time Frame
pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention]
Title
Change in Eating Disorder Symptoms
Description
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.
Time Frame
pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention]
Secondary Outcome Measure Information:
Title
Change in Glycemic Control
Description
Objectively assessed HbA1c (at clinic or by a self-test kit)
Time Frame
pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention]
Title
Change in Time-In-Range (TIR)
Description
TIR past 14 days, screen shot of device. Time-Above-Range (TAR) and Time-Below-Range (TBR) are also recorded
Time Frame
pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention]
Title
Change in Health Care Utilization
Description
service utilization will be assessed with an adapted version of the Patterns of Help Seeking Behavior Scale (Lane & Addis, 2005). Participants in both conditions will be asked to report frequency of care the past year for physical, mental health, eating, and weight problem
Time Frame
pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention]
Title
Change over time in Diabetes-Specific Distress
Description
Assessed with the 20-item Problem Areas In Diabetes scale (PAID) which measures distress related to diabetes. High scores indicate greater distress that are related to living with Type 1 Diabetes
Time Frame
pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention]
Title
Change over time in Diabetes-Related Quality of Life
Description
Assessed with the adolescent version (23 items) (Hilliard et al., 2020)and young adult version (27-items) of Type 1 Diabetes and Life (T1DAL) measures (Hilliard et al., 2021)assess diabetes specific health-related quality of life among participants with T1D. Total scores are transformed to a 0-100 scale and enables comparison of scores across age ranges. Higher scores indicate greater distress.
Time Frame
pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention]
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
Groups are single-gendered. Most participants (280) will be female-identifying. Each site is also going to recruit 1 group (about 6 individuals) of male-identifying individuals as to pilot the intervention with men. In total, there will be about 30 male-identifying individuals for a total sample of 310.
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
between the ages of 14-35
diagnosis of Type 1 Diabetes of at least 1 year
using insulin
experiencing at least some level of body image concerns
Exclusion Criteria:
not between the ages of 14-35
does not have access to wifi (will need for the virtual groups)
Type 1 Diabetes diagnosis of less than 1 year
does not live in the same time zone of Stanford (helps in coordinating groups)
hospitalized for eating disorder treatment in the past year
had eating-disorder related Diabetic Ketoacidosis (DKA) in the past year
not using insulin
not experiencing any level of body image concerns
Unwilling to be video-recorded if assigned to Diabetes Body Project
restricted proficiency in language that groups will be conducted in (dependent on location), and pervasive developmental, cognitive, or psychiatric limitations that compromise participation in the intervention sessions and study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Rubino, BA
Phone
6505494829
Email
lrubino@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
May Stern, BA
Email
mstern1@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Line Wisting, PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric Stice, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elena Toschi, MD
Organizational Affiliation
Joslin Diabetes Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maartje de Wit, PhD
Organizational Affiliation
Amsterdam Medical University Centers
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Rubino, BA
Phone
650-549-4829
Email
lrubino@stanford.edu
First Name & Middle Initial & Last Name & Degree
May Stern, BA
Email
mstern1@stanford.edu
First Name & Middle Initial & Last Name & Degree
Eric Stice, PhD
Facility Name
Joslin Diabetes Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madeline Bennetti, BA
Email
Madeline.Bennetti@joslin.harvard.edu
First Name & Middle Initial & Last Name & Degree
Elena Toschi, PhD
Facility Name
Amsterdam Medical University Center
City
Amsterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maartje de Wit, PhD
Email
m.dewit@amsterdamumc.nl
First Name & Middle Initial & Last Name & Degree
Maartje de Wit, PhD
Facility Name
Oslo University Hospital
City
Oslo
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Line Wisting, PhD
Email
uxwili@ous-hf.no
First Name & Middle Initial & Last Name & Degree
Line Wisting, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Multi-Site Eating Disorder Prevention Program for Type 1 Diabetes
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