The Diabetes Body Project: Multi-site trial of a virtually delivered eating disorder prevention program for young females with type 1 diabetes

Young females with type 1 diabetes (T1D) show a 60% lifetime incidence of
eating disorders, which is 462% greater than in young females without T1D.
Eating disorder behaviors (e.g., dietary restriction, insulin omission) and
symptoms (e.g., binge eating, vomiting for weight loss) increase risk for poor
glycemic control and consequent morbidity and mortality from T1D.
Theoretically, T1D amplifies pursuit of the thin appearance ideal, body
dissatisfaction, dietary restriction, and negative affect, which are
established risk factors for eating disorders because insulin treatment causes
weight gain, strict dietary control is necessary for T1D management, and T1D
contributes to negative affect (e.g., depression and anxiety). Thus, developing
and evaluating interventions that prevent eating disorder symptoms/behaviors
and eating disorder onset in this ultra-high-risk population is a key public
health priority.

We aim to investigate the efficacy of a novel eating disorder prevention
program, the Diabetes Body Project, specifically targeting young females T1D.
Firstly, we will test the hypothesis that Diabetes Body Project will produce
significantly greater reductions in eating disorder behaviors, eating disorder
symptoms, and future eating disorder onset among young people with T1D over
2-year follow-up than educational controls (primary outcomes). Further, we will
test the hypothesis that Diabetes Body Project participants will show greater
improvements in diabetes distress, diabetes illness perceptions, and quality of
life over 2-year follow-up than educational controls (secondary outcomes).
Moreover, we will test the hypothesis that Diabetes Body Project participants
will show greater improvements in glycemic control (HbA1c and time-in-range;
TIR), and reduction in episodes of diabetic ketoacidosis, and hospitalization
over 2-year follow-up than educational controls.

This is an international, multi-site collaboration, inviting young females with
T1D in Oslo (Norway), Amsterdam (the Netherlands), Boston (USA), and San
Francisco (USA) to participate in a randomized controlled trial including two
body acceptance interventions: The Diabetes Body Project and educational
video*s.

Diabetes Body Project: 6 weekly 1-hour virtual group sessions

All participants will complete questionnaires online 5 times over the 2 years.
This will take approximately 30 minutes per measurement point. In addition
diagnostic interviews will be conducted by telephone which take about 30
minutes as well. To assess HbA1c, participants will receive a test kit at home
and be asked to draw blood by a finger prick, comparable with their regular
blood glucose tests. Participants in the Diabetes Body Project group will
participate in six 1-hour group sessions (weekly). Participants in the
educational control group will be asked to watch 6 hours of educational
video*s. Both groups might benefit in terms of body acceptance and eating
behaviours as it has been shown that the educational videos are effective
although probably not as effective as the Diabetes Body Project.
Based on experiences from more than 20 years of standard Body Project research,
potential risk to participants are considered minimal and unlikely. In terms of
the Diabetes Body Project, a pilot was conducted at Oslo University Hospital.
No adverse effects were recorded. However, a couple of participants withdrew
from the study stating that during the course of the group meetings, they had
realized that they had more challenges related to body image than they were
previously aware of, which made group meetings difficult. In those cases, we
had a conversation with them and agreed that they should talk to their diabetes
clinician about this individually. For the remaining participants, qualitative
interviews post Diabetes Body Project participation revealed that they had
increased awareness and more tools to deal with body pressures and body image
concerns. This finding is also supported by our quantitative pilot data,
showing significant improvements in ED risk factors and symptoms. Based on
this, we are confident that benefits outweighs the potential risks for research
participants and others.