Objective
The overarching objective of the proposed project is to gain knowledge about how to prevent eating disorders among young females with type 1 diabetes (T1D). We propose to conduct a rigorous randomized trial of a novel eating disorder prevention program for adolescent girls and young women with T1D, which is a group that is at ultra-high risk for eating disorders. This is because the unique demands of keeping blood sugar levels in a healthy range to avoid serious diabetes-related medical complications and premature death markedly increases risk for the development of eating pathology. We adapted an eating disorder prevention program that has the strongest evidence-base for young females with T1D. Young females who were assigned to this prevention program (the Diabetes Body Project) showed medium to large reductions in eating disorder symptoms and behaviors, and diabetes distress, in a preliminary uncontrolled trial. We propose to recruit 240 adolescent girls/young adult females with T1D in Oslo, Amsterdam, Boston, and San Francisco and randomize them to virtually-delivered Diabetes Body Project groups or a T1D/eating disorder education intervention. Participants will complete assessments five times over a 2-year follow-up. The first aim of the proposed project is to test whether the Diabetes Body Project will produce significantly greater reductions in eating disordered behaviors and symptoms, and future eating disorder onset among young people with T1D over 2-year follow-up than those randomized to a T1D and eating disorder educational control condition. The second aim is to test whether 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. The third aim is to test whether 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. Additional exploratory aims include; i) to adapt the Diabetes Body Project for males and run approximately 4 groups to examine acceptability and provide an initial uncontrolled evaluation of reductions in outcomes, and ii) explore whether the Diabetes Body Project participants show greater uptake of diabetes-related technology (continuous glucose monitors and insulin pumps) to manage diabetes compared to baseline and educational controls.
Background Rationale
Type 1 diabetes (T1D) is a chronic illness caused by autoimmune destruction of cells that produce insulin, wherein the lack of insulin causes elevated blood glucose. Poor glucose control is associated with diabetes complications, such as cerebrovascular and cardiovascular disease, neurological complications, and mortality. The continuous self-regulation task of adjusting insulin to diet, physical activity, and emotional state to maintain healthy blood glucose levels is accompanied by the threat of serious diabetes complications. This ongoing regulation task places a high burden on youth with T1D and increases risk for eating pathology. Indeed, young women with versus without T1D show a 200-500% higher prevalence of eating disorders, as well as elevated eating disorder behaviors, such as dietary restriction and intentional insulin omission for weight control, and symptoms, such as binge eating and fasting, excessive exercise, vomiting, and laxative/diuretic misuse for weight control. Unfortunately, eating pathology increases risk for poorer glycemic control, as indexed by higher Hemoglobin A1c (HbA1c), and premature mortality. Adolescents and young adults with T1D and eating disorders have a 600% higher risk of death compared with their peers without eating disorders, underscoring the importance of effective prevention efforts for this patient group. No intervention has been shown to prevent this co-morbidity. Although dozens of eating disorder prevention programs have been developed, only the Body Project has reduced future onset of eating disorders in multiple trials, produced effects when evaluated by independent research teams, produced stronger effects than credible alternative interventions, and affected objective outcomes. The Body Project is a brief 4-hour group-delivered intervention wherein high-risk young women with body image concerns collectively critique pursuit of the thin appearance ideal in verbal, written, and behavioral exercises, which reduces pursuit of this unrealistic ideal and eating disordered behaviors used to pursue this ideal. Intervention effects have been found to persist through 3- and 4-year follow-up. A unique feature about the Body Project is that it has shown efficacy when implemented virtually via videoconferencing. Indeed, intervention effects are larger for virtual versus in-person groups. Virtual implementation could markedly expand the reach of this prevention program to youth with T1D. An uncontrolled pilot trial provided a preliminary feasibility assessment of a novel 6-hour virtually-delivered T1D-adapted version of the Body Project (Diabetes Body Project). Participants were 35 16-35 year-old young women with T1D. Results suggest that the Diabetes Body Project was acceptable among both participants and group facilitators. Participants assigned to virtual Diabetes Body Project groups showed significant reductions in pursuit of the thin ideal, body dissatisfaction, dietary restraint, diabetes eating pathology, and diabetes distress at posttest, with effects persisting through 6-month follow-up. This trial also revealed that this intervention improved blood glucose control more than other interventions that have sought to improve this outcome. Given the robust evidence of the effectiveness of the Body Project for individuals without T1D and the promising preliminary data for the Diabetes Body Project, we propose to conduct a fully-powered efficacy trial of this eating disorder prevention program for young women with T1D. We will recruit 240 adolescents and young adults with T1D at four sites (Oslo, Amsterdam, Boston, and San Francisco) and randomize them to the Diabetes Body Project or a T1D/eating disorder education intervention and assess participants over a 2-year follow-up, allowing us to detect whether this intervention reduces current eating pathology and future onset of eating disorders. Diabetes Body Project groups will be co-implemented by a clinician and a peer educator with T1D because peer-leader co-implementation increased efficacy of the standard Body Project. Peer educators have produced larger intervention effects than clinicians for other interventions that target adolescents and young adults.
Description of Project
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. Fortunately, the Body Project eating disorder prevention program has produced greater reductions in eating disorder risk factors, behaviors, symptoms, and future onset of eating disorders than assessment-only control conditions and alternative interventions (including educational control conditions) among adolescent girls and young women in over 20 controlled trials. For instance, virtually delivered (via Zoom) Body Project groups produced a 77% reduction in future onset of eating disorders over 2-year follow-up compared to a credible placebo intervention. An uncontrolled feasibility study found that young women with T1D who were assigned to complete a virtual version of this intervention adapted for youth with T1D (the Diabetes Body Project) showed significant reductions in pursuit of the thin ideal (d = .81), body dissatisfaction (d = .67), dietary restraint (d = .63), diabetes eating pathology (d = .83), and diabetes distress (d = .48), though reductions in hemoglobin A1c (HbA1c) were not significant (d = .23). Cohen’s d reflects reductions in standard deviation units, with .30, .50, and .80 corresponding to small, medium, and large effects. Given that the reductions in HbA1c were larger than the average effect produced by other interventions targeting glycemic control (d = .11) and the promising preliminary data, we propose to conduct a fully-powered 4-site efficacy trial of a refined version of the Diabetes Body Project. Specifically, we will recruit 240 adolescent girls/young adult women with T1D over a 2-year period in Oslo, Amsterdam, Boston, and San Francisco and randomize them to virtually-delivered Diabetes Body Project groups or a T1D/eating disorder education intervention. Participants will complete assessments measuring eating pathology, diabetes distress, and glycemic control five times over a 2-year follow-up. Based on evidence that Body Project produces significantly stronger eating disorder prevention effects when groups are co-implemented by peer educators, groups will be co-implemented by a clinician and a peer educator with T1D. The first aim is to test whether Diabetes Body Project participants will show significantly greater reductions in eating disorder behaviors, symptoms, and future eating disorder onset over 2-year follow-up than educational controls. The second aim is to test whether Diabetes Body Project participants will show significantly greater improvements in diabetes distress, diabetes illness perceptions, and quality of life over 2-year follow-up than educational lecture controls. The third aim is to test whether Diabetes Body Project participants will show significantly greater improvements in glycemic control (HbA1c and Time in Range), episodes of diabetes-related complications (diabetes ketoacidosis), and hospitalization over 2-year follow-up than educational lecture controls.
Anticipated Outcome
Based on positive effects of the Body Project eating disorder prevention program that was developed for the general population and the encouraging preliminary feasibility results of the version of this prevention program that was adapted for young females with T1D (the Diabetes Body Project), we anticipate that young females with T1D who are randomized to this brief 6-hour virtually delivered prevention program will show significantly greater reductions in eating disorder risk factors, eating disorder behaviors, eating disorder symptoms, and future onset of eating disorders than young females with T1D who are assigned to a T1D/eating disorder educational control condition. We likewise anticipate that the Diabetes Body Project will produce significantly stronger reductions in diabetes distress, diabetes illness perceptions, quality of life, blood glucose control and diabetes-complicaitons than educational controls. These diabetes-specific variables have previously been found to be associated with eating disorder psychopathology, especially among young females. If virtually implemented Diabetes Body Project groups produce significant reductions in the outcomes in this trial, it could be widely implemented to reduce T1D-related morbidity and mortality. The standard Body Project has been implemented to over 6-million adolescent girls and young women in 140 countries to date and is currently being implemented at over 200 universities in the United States (Stice et al., 2021). The fact that the Diabetes Body Project could be implemented virtually could markedly expand reach because it avoids the barrier of having to live near someplace where in-person group-based prevention programs or offered. We plan on making the intervention script freely available for anyone to use and encourage people to translate the intervention into other languages that will also be made freely available because this approach has played a major role in the broad implementation of the standard Body Project. Importantly, should the Diabetes Body Project prove effective, the results of this study will have immediate implications for clinical practice. The complete manual, tested for its effectiveness, will be made available to T1D clinics to use with at-risk patients. The intervention is designed to be translational and suitable for already existing members of a multidisciplinary T1D team to implement in outpatient settings. The Diabetes Body Project script and materials available are for free, including group facilitator training. Moreover, peer educator co-implementation may further increase acceptability, efficacy, and reduce potential barriers. As such, the proposed project will contribute to fill knowledge gaps within the T1D and eating disorder field, and may contribute to the broad prevention of future eating disorder onset among ultra-high-risk patients. This study will be the first to investigate the efficacy of a diabetes-specific eating disorder prevention program among young females with T1D, known to be at high risk for developing eating disorders. We hypothesize that participants receiving Diabetes Body Project will show significant reductions in eating disorder risk factors, symptoms, and future eating disorder onset compared to the control condition.
Relevance to T1D
Young females with type 1 diabetes (T1D) are at an increased risk of developing eating disorders. Eating disorders are serious mental illnesses with severe psychological and physiological consequences for the individuals and their families. Eating disorders have the highest mortality rate of all mental illnesses. Given that concurrent eating disorders in individuals with T1D dramatically increases rates of morbidity and mortality, it is critical to develop interventions to prevent this lethal comorbidity. Both T1D clinicians and user organizations have recognized that no effective interventions exist to reduce and prevent eating pathology in among patients affected by T1D. Access to a low-cost, brief, effective eating disorder prevention program, accompanied by sufficient training to facilitate the groups, is critical for individuals with T1D, their loved ones, T1D clinicians, and T1D user organizations. The fact that the Diabetes Body Project can be delivered virtually by peer educators, reduces costs and practical barriers to access and increases availability and facilitates broad implementation. To strengthen the relevance for individuals with T1D, the two final sessions in the Diabetes Body Project include diabetes-specific content such as attitudes to insulin, diabetes illness perceptions, diabetes distress, and quality of life. These diabetes psychological constructs have been found to be associated with eating disorder psychopathology and glycemic control among individuals with T1D, especially young females. The results from our preliminary uncontrolled feasibility study in Norway showed significant improvements in diabetes illness perceptions and diabetes distress after participating in the Diabetes Body Project (posttest), with medium to large effect sizes, and even continued to improve at 6-month follow-up. Importantly, the participants additionally expressed that meeting other young females with T1D was one of the most important aspects of participating in the Diabetes Body Project, and that being a part of this community with peers helped them feel less alone with their diabetes. Taken together, it is our hope that the proposed project will contribute to prevent eating disorders among young females with T1D, thereby potentially decreasing the risk for subsequent poor glycemic control and poor prognosis.