Feeding and Eating DisordersDBPNCT04837989
Effectiveness of the Diabetes Body Project Among Females With Type 1 Diabetes
A study testing Diabetes Body Project and Psychoeducation in people with Feeding and Eating Disorders and Diabetes Mellitus, Type 1, run by Oslo University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 16 to 35 years, women only
- Conditions the study is for
- Feeding and Eating Disorders, Diabetes Mellitus, Type 1, Body Image
- What is being tested?
- Diabetes Body Project and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteNorway
- Study dates
- 1 Feb 2021to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 35 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Female, 16-35 years, type 1 diabetes, acknowledges at least some level of body image concerns
Who cannot join
- Other forms of diabetes, males
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diabetes Body Project: Effectiveness of a Virtually Delivered Eating Disorder Prevention Program Among Young Females With Type 1 Diabetes
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.
Read the 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.
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.
- Being tested
- Diabetes Body Project, Psychoeducation
- Medical subject headings
- Feeding and Eating Disorders, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Body ProjectBehavioural
Six virtually delivered Diabetes Body Project groups over six weeks (one hour a week); 5-6 participants and 2 group facilitators
PsychoeducationBehavioural
Individuals assigned to the psychoeducational control condition will receive an educational brochure, and complete similar assessments and assessment time points as the experimental condition. Individuals in the control group will be offered Diabetes Body Project group participation after six months.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Body Project | Experimental | Participants randomized to the experimental condition will receive virtual Diabetes Body Project groups immediately. Receives: Behavioral: Diabetes Body Project |
| 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. Receives: Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Ideal-Body Stereotype Scale-Revised (IBSS-R)
Thin beauty ideal internalization, scores range from 1-5, higher scores indicate higher levels of internalization
Measured: Baseline, change from baseline to 6 weeks, change from baseline to 6-months
The Body Parts Scale
Nine items on body dissatisfaction, scores range from 1-5, higher scores indicate more body dissatisfaction
Measured: Baseline, change from baseline to 6 weeks, change from baseline to 6-months
Dietary restraint
Eating restriction, scores range from 1-5, higher scores indicate more eating restriction
Measured: Baseline, change from baseline to 6 weeks, change from baseline to 6-months
The Diabetes Eating Problem Survey - Revised
Total score to indicate level of eating disorder psychopathology, scored 0-5, higher scores indicate higher levels of eating disorder psychopathology
Measured: Baseline, change from baseline to 6 weeks, change from baseline to 6-months
Social attitudes towards appearance questionnaire (SATAQ) 4R
Appearance pressures and internalization, answers range from 1-5, higher scores indicate more pressures/internalization
Measured: Baseline, change from baseline to 6 weeks, change from baseline to 6-months
Social Comparison Scale
The degree to which individuals compare themselves to others, score 1-10, higher scores indicate more favorable social compariso
Measured: Baseline, change from baseline to 6 weeks, change from baseline to 6-months
Secondary outcomes (3)
Blood glucose control
Hemoglobin A1c (HbA1c) and time in range. Higher HbA1c indicate poorer blood glucose control. Higher time in range indicate better blood glucose control
Measured: Baseline, change from baseline to 6 weeks, change from baseline to 6-months
Problem Areas in Diabetes (PAID)
Diabetes distress, scored 0-4, higher scores indicate higher degree of diabetes distress
Measured: Baseline, change from baseline to 6 weeks, change from baseline to 6-months
Brief Illness Perception Questionnaire
Diabetes illness perceptions, scores range from 0-10, higher scores indicate more threatening/negative of their diabetes
Measured: Baseline, change from baseline to 6 weeks, change from baseline to 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 Feb 2021
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Why it stopped: Data will be written up as a pilot RCT study and experiences and results will inform the start of a multi-site trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding and Eating DisordersStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Dam Foundation, Norwegian Diabetes Association
- Responsible party
- Principal investigator, Line Wisting, Oslo University Hospital
- Investigators
- Line Wisting, PhD, Principal investigator, Oslo University Hospital, Division of Mental Health and Addiction
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04837989
- Sponsor's protocol ID
- 6860
- Acronym
- DBP
- Status last verified
- Aug 2023
- First submitted
- 29 Mar 2021
- Last updated
- 4 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Body Project: Effectiveness of a Virtually Delivered Eating Disorder Prevention Program Among Young Females With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04837989
- Acronym / sponsor ID
- DBP / 6860
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Data will be written up as a pilot RCT study and experiences and results will inform the start of a multi-site trial
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- The Dam Foundation, Norwegian Diabetes Association
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes Body Project | Experimental | Behavioral: Diabetes Body ProjectParticipants randomized to the experimental condition will receive virtual Diabetes Body Project groups immediately. |
| Educational | Active comparator | Behavioral: PsychoeducationParticipants randomized to the control condition will receive an education brochure and will be offered the Diabetes Body Project after 6 months. |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Female, 16-35 years, type 1 diabetes, acknowledges at least some level of body image concerns
Key exclusion criteria (1 listed)
- Other forms of diabetes, males
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetes Body ProjectSix virtually delivered Diabetes Body Project groups over six weeks (one hour a week); 5-6 participants and 2 group facilitators | Behavioural | Diabetes Body Project |
| PsychoeducationIndividuals assigned to the psychoeducational control condition will receive an educational brochure, and complete similar assessments and assessment time points as the experimental condition. Individuals in the control group will be offered Diabetes Body Project group participation after six months. | Behavioural | Educational |
Primary outcome
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
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
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
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
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
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
3 secondary outcomes
Blood glucose control
Time frame: Baseline, change from baseline to 6 weeks, change from baseline to 6-months
Problem Areas in Diabetes (PAID)
Time frame: Baseline, change from baseline to 6 weeks, change from baseline to 6-months
Brief Illness Perception Questionnaire
Time frame: Baseline, change from baseline to 6 weeks, change from baseline to 6-months
Results and safety
The study was stopped early (reason given: Data will be written up as a pilot RCT study and experiences and results will inform the start of a multi-site trial). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Line Wisting, PhD principal investigator
Oslo University Hospital, Division of Mental Health and Addiction
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Body Project and Psychoeducation in people with Feeding and Eating Disorders and Diabetes Mellitus, Type 1, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Data will be written up as a pilot RCT study and experiences and results will inform the start of a multi-site trial). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Ideal-Body Stereotype Scale-Revised (IBSS-R) (time frame: Baseline, change from baseline to 6 weeks, change from baseline to 6-months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.