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Clinical Trials/NCT04837989
NCT04837989TerminatedNot Applicable

Diabetes Body Project: Effectiveness of a Virtually Delivered Eating Disorder Prevention Program Among Young Females With Type 1 Diabetes

Oslo University Hospital1 site in 1 country58 target enrollmentStarted: February 1, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor
Enrollment
58
Locations
1
Primary Endpoint
The Ideal-Body Stereotype Scale-Revised (IBSS-R)

Study Overview

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, 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.

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 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
16 Years to 35 Years (Child, Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Female, 16-35 years, type 1 diabetes, acknowledges at least some level of body image concerns

Exclusion Criteria

  • •Other forms of diabetes, males

Arms & Interventions

Diabetes Body Project

Experimental

Participants randomized to the experimental condition will receive virtual Diabetes Body Project groups immediately.

Intervention: Diabetes Body Project (Behavioral)

Educational

Active Comparator

Participants randomized to the control condition will receive an education brochure and will be offered the Diabetes Body Project after 6 months.

Intervention: Psychoeducation (Behavioral)

Outcomes

Primary Outcomes

The Ideal-Body Stereotype Scale-Revised (IBSS-R)

Time Frame: Baseline, change from baseline to 6 weeks, change from baseline to 6-months

Thin beauty ideal internalization, scores range from 1-5, higher scores indicate higher levels of internalization

Social Comparison Scale

Time Frame: Baseline, change from baseline to 6 weeks, change from baseline to 6-months

The degree to which individuals compare themselves to others, score 1-10, higher scores indicate more favorable social compariso

Dietary restraint

Time Frame: Baseline, change from baseline to 6 weeks, change from baseline to 6-months

Eating restriction, scores range from 1-5, higher scores indicate more eating restriction

Social attitudes towards appearance questionnaire (SATAQ) 4R

Time Frame: Baseline, change from baseline to 6 weeks, change from baseline to 6-months

Appearance pressures and internalization, answers range from 1-5, higher scores indicate more pressures/internalization

The Body Parts Scale

Time Frame: Baseline, change from baseline to 6 weeks, change from baseline to 6-months

Nine items on body dissatisfaction, scores range from 1-5, higher scores indicate more body dissatisfaction

The Diabetes Eating Problem Survey - Revised

Time Frame: Baseline, change from baseline to 6 weeks, change from baseline to 6-months

Total score to indicate level of eating disorder psychopathology, scored 0-5, higher scores indicate higher levels of eating disorder psychopathology

Secondary Outcomes

  • Blood glucose control(Baseline, change from baseline to 6 weeks, change from baseline to 6-months)
  • Problem Areas in Diabetes (PAID)(Baseline, change from baseline to 6 weeks, change from baseline to 6-months)
  • Brief Illness Perception Questionnaire(Baseline, change from baseline to 6 weeks, change from baseline to 6-months)

Investigators

Sponsor
Oslo University Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Line Wisting

Researcher, PhD

Oslo University Hospital

Study Sites (1)

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