Clinical Trial Details
— Status: Terminated
Administrative data
NCT number |
NCT04837989 |
Other study ID # |
6860 |
Secondary ID |
|
Status |
Terminated |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
February 1, 2021 |
Est. completion date |
July 31, 2022 |
Study information
Verified date |
August 2023 |
Source |
Oslo University Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Young females with type 1 diabetes (T1D) is at high risk of eating disorders (ED), with
prevalence rates of ED more than double those of non-diabetes peers. T1D and ED are both
associated with serious somatic complications, and when occurring together the prognosis is
even worse. Despite the frequency and severity of this comorbidity, there is a lack of
intervention studies and no consensus on how to best prevent and treat this comorbidity. To
remedy this, we have developed a virtual diabetes-adapted version of the ED prevention
program Body Project, i.e. the Diabetes Body Project. This study examines the effectiveness
of the Diabetes Body Project to reduce ED risk factors and symptoms among young females with
T1D.
Description:
Type 1 Diabetes (T1D) T1D is caused by an autoimmune destruction of the insulin-producing
beta cells in the pancreas, leading to complete lack of insulin. Insulin is necessary to
regulate blood glucose levels. T1D is a national and international health challenge and
priority, and Norway has among the highest incidence of T1D in the world. This is a growing
problem (incidence in Norway has increased by 30% in the last 15 years) with profound
long-term complications due to sub optimal metabolic control, including atherosclerosis, with
subsequent cerebrovascular and cardiovascular disease, retinopathy, neuropathy and
nephropathy.
Significant rates of psychological problems are associated with T1D. One study investigated
young patients with T1D and found that 11% screened positive for depression, 21% for anxiety,
and 21% for disordered eating. Patients with a positive screen had twice the odds of having
poor metabolic control (high HbA1c) as those without. Other psychological correlates reported
to influence T1D self-care and metabolic control include illness perceptions, attitudes to
insulin, and quality of life.
Eating disorders and Disturbed Eating Behaviors (DEB) ED affect approximately 5% of the
female Norwegian population between the ages of 15-44 years, and onset is most common during
adolescence. ED are characterized by disordered eating such as restricted intake or bingeing
and purging, a morbid preoccupation with food, weight and shape and major disturbances in
cognition with distortion of body image. The main eating disorders as defined in the
Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) are Anorexia Nervosa (AN),
Bulimia Nervosa (BN), Binge Eating Disorder (BED), and Otherwise Specified Feeding and Eating
Disorders (OSFED). A large amount of disturbed eating behaviors do not meet full criteria for
the diagnoses described above and is often referred to as sub-clinical eating problems or
disturbed eating behaviors. The term "disturbed eating behavior" (DEB) is used here to refer
to sub-clinical eating problems.
Comorbid T1D and DEB Numerous studies indicate that T1D is a risk factor for the development
of DEB. Possible mediating factors include weight loss accompanying disease onset, weight
gain with the initiation of insulin treatment, dietary restraint as part of diabetes
management, and the deliberate insulin under dosing or omission as an effective weight loss
strategy. However, few longitudinal studies of comorbid T1D and DEB exist, and there is a
lack of knowledge about the specific risk factors for the development of DEB in T1D. One
recent longitudinal study states that DEB was common and persistent in their sample of
adolescent females with T1D. At the 14-year follow-up, a total of 32% met criteria for a
current eating disorder, and DEB was reported in 59% of the participant, confirming the
severity of this comorbidity. The cumulative probability of onset was 60% by the age of 25
years.
DEB is common and persistent in young women with T1D, with prevalence rates double those of
non-diabetic populations. Our prior study found that the prevalence of DEB was 27% among
young Norwegian girls with T1D, indicating that these comorbidities are common in Norway.
Comorbid T1D and DEB are associated with poor metabolic control and increased rates of
morbidity and mortality. For example in Nielsen's study of comorbid T1D and anorexia nervosa,
the mortality rate at 10 years follow-up was 2.5 % for T1D and 6.5% for anorexia nervosa;
though when comorbid it rose to 35%. DEB also poses a risk of serious physical complications,
thereby contributing to much poorer prognosis.
The nature of T1D-specific DEB It has been suggested that the nature of DEB in T1D is
specific and qualitatively different from DEB in non-diabetes populations. It is hypothesized
that a diabetes-specific DEB has its origins in the nature and course of T1D and T1D
treatment. T1D constitutes a considerable burden on the young patients and their families.
The continuous self-regulation task of adjusting insulin dose to diet, physical activity and
emotional state to maintain blood glucose levels according to recommendations is accompanied
by the threat of developing serious diabetes late complications. Such factors may contribute
to increased weight- and shape concerns among patients with T1D (particularly females).
Reducing or omitting insulin is an efficient weight loss strategy uniquely available to
individuals with diabetes, but is associated with increased morbidity and mortality. In
addition to insulin restriction, bulimic features such as binge eating and self-induced
vomiting or misuse of laxatives are common symptoms of DEB in T1D.
Despite the frequency and severity of comorbid T1D and DEB/ED, there is a lack of studies on
how to prevent this condition. The Body Project is reported to be the most effective ED
prevention program in the general population, but this has not been tested in a T1D
population. The overall aim of this study is therefore to evaluate a diabetes-adapted version
of the ED prevention program the Body Project (i.e. the Diabetes Body Project) among young
females with T1D. Specifically, we hypothesize that the Diabetes Body Project can improve i)
ED risk factors (i.e. thin beauty ideal internalization, body dissatisfaction, and dietary
restraint) and symptoms (ED measure composite score); ii) blood glucose control (i.e.
Hemoglobin A1c and time in range); and iii) diabetes-specific psychological aspects (i.e.
diabetes distress and illness perceptions) relative to an educational condition.