Diabetes Body Project for Diabetes, Autoimmune

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Oslo University Hospital, Oslo, Norway
Diabetes, Autoimmune+4 More
Diabetes Body Project - Behavioral
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Diabetes, Autoimmune
  • Type 1 Diabetes Mellitus
  • Eating Disorders

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

15 Primary · 0 Secondary · Reporting Duration: pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention]

Month 6
Change in Eating Disorder Symptoms
Change in Glycemic Control
Change in Health Care Utilization
Change in Time in Illness Perceptions
Change in Timem in Illness Perceptions
Change over time Glycemic Control
Change over time in Body Dissatisfaction
Change over time in Diabetes-Related Quality of Life
Change over time in Diabetes-Specific Distres
Change over time in Diabetes-Specific Distress
Change over time in Diabetes-Specific Eating Pathology
Change over time in Dieting
Change over time in Ideal Body Beliefs
Change over time in Negative Affect
Change over time in Perceived Well-Being as assessed by the World Health Organization Well-Being Index (WHO-5; deWit et al., 2007).

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Educational Group
1 of 2
Diabetes Body Project
1 of 2
Active Control
Experimental Treatment

310 Total Participants · 2 Treatment Groups

Primary Treatment: Diabetes Body Project · No Placebo Group · N/A

Diabetes Body Project
Behavioral
Experimental Group · 1 Intervention: Diabetes Body Project · Intervention Types: Behavioral
Educational Group
Behavioral
ActiveComparator Group · 1 Intervention: Educational Group · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention]
Closest Location: Joslin Diabetes Center · Boston, MA
Photo of Boston 1Photo of Boston 2Photo of Boston 3
1995First Recorded Clinical Trial
0 TrialsResearching Diabetes, Autoimmune
129 CompletedClinical Trials

Who is running the clinical trial?

Juvenile Diabetes Research FoundationOTHER
199 Previous Clinical Trials
55,006 Total Patients Enrolled
1 Trials studying Diabetes, Autoimmune
58 Patients Enrolled for Diabetes, Autoimmune
Amsterdam UMC, location VUmcOTHER
320 Previous Clinical Trials
143,040 Total Patients Enrolled
University of MinnesotaOTHER
1,227 Previous Clinical Trials
1,454,092 Total Patients Enrolled
Joslin Diabetes CenterOTHER
90 Previous Clinical Trials
19,764 Total Patients Enrolled
Oslo University HospitalLead Sponsor
961 Previous Clinical Trials
1,133,486 Total Patients Enrolled
Stanford UniversityOTHER
2,130 Previous Clinical Trials
35,668,600 Total Patients Enrolled
Eric Stice, PhDPrincipal InvestigatorStanford University
10 Previous Clinical Trials
4,536 Total Patients Enrolled
Line Wisting, PhDPrincipal InvestigatorOslo University Hospital
1 Previous Clinical Trials
200 Total Patients Enrolled
Elena Toschi, MDPrincipal InvestigatorJoslin Diabetes Center
1 Previous Clinical Trials
35 Total Patients Enrolled
Maartje de Wit, PhDPrincipal InvestigatorAmsterdam Medical University Centers

Eligibility Criteria

Age < 65 · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.