Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04837989
Status:
TERMINATED
Last Update Posted:
2023-08-04
First Post:
2021-03-29
Brief Title:
Effectiveness of the Diabetes Body Project Among Females With Type 1 Diabetes
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Diabetes Body Project Effectiveness of a Virtually Delivered Eating Disorder Prevention Program Among Young Females With Type 1 Diabetes
Status:
TERMINATED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Data will be written up as a pilot RCT study and experiences and results will inform the start of a multi-site trial
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DBP
Brief 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 ie 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
Detailed 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 Nielsens study of comorbid T1D and anorexia nervosa the mortality rate at 10 years follow-up was 25 for T1D and 65 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 DEBED 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 ie the Diabetes Body Project among young females with T1D Specifically we hypothesize that the Diabetes Body Project can improve i ED risk factors ie thin beauty ideal internalization body dissatisfaction and dietary restraint and symptoms ED measure composite score ii blood glucose control ie Hemoglobin A1c and time in range and iii diabetes-specific psychological aspects ie diabetes distress and illness perceptions relative to an educational condition
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 Nielsens study of comorbid T1D and anorexia nervosa the mortality rate at 10 years follow-up was 25 for T1D and 65 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 DEBED 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 ie the Diabetes Body Project among young females with T1D Specifically we hypothesize that the Diabetes Body Project can improve i ED risk factors ie thin beauty ideal internalization body dissatisfaction and dietary restraint and symptoms ED measure composite score ii blood glucose control ie Hemoglobin A1c and time in range and iii diabetes-specific psychological aspects ie diabetes distress and illness perceptions relative to an educational condition
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None