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Effectiveness of the Diabetes Body Project Among Females With Type 1 Diabetes (DBP)

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ClinicalTrials.gov Identifier: NCT04837989
Recruitment Status : Recruiting
First Posted : April 8, 2021
Last Update Posted : April 8, 2021
Sponsor:
Collaborators:
Dam Foundation
Norwegian Diabetes Association
Information provided by (Responsible Party):
Line Wisting, Oslo University Hospital

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.

Condition or disease Intervention/treatment Phase
Feeding and Eating Disorders Diabetes Mellitus, Type 1 Body Image Behavioral: Diabetes Body Project Behavioral: Psychoeducation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Diabetes Body Project: Effectiveness of a Virtually Delivered Eating Disorder Prevention Program Among Young Females With Type 1 Diabetes
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : July 30, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Diabetes Body Project
Participants randomized to the experimental condition will receive virtual Diabetes Body Project groups immediately.
Behavioral: Diabetes Body Project
Six virtually delivered Diabetes Body Project groups over six weeks (one hour a week); 5-6 participants and 2 group facilitators

Active Comparator: Educational
Participants randomized to the control condition will receive an education brochure and will be offered the Diabetes Body Project after 6 months.
Behavioral: Psychoeducation
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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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


Secondary Outcome Measures :
  1. Blood glucose control [ Time Frame: Baseline, change from baseline to 6 weeks, change from baseline to 6-months ]
    Hemoglobin A1c (HbA1c) and time in range. Higher HbA1c indicate poorer blood glucose control. Higher time in range indicate better blood glucose control

  2. Problem Areas in Diabetes (PAID) [ Time Frame: Baseline, change from baseline to 6 weeks, change from baseline to 6-months ]
    Diabetes distress, scored 0-4, higher scores indicate higher degree of diabetes distress

  3. Brief Illness Perception Questionnaire [ Time Frame: Baseline, change from baseline to 6 weeks, change from baseline to 6-months ]
    Diabetes illness perceptions, scores range from 0-10, higher scores indicate more threatening/negative of their diabetes



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Ages Eligible for Study:   16 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04837989


Contacts
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Contact: Anne Louise Wennersberg 97076244 uxweac@ous-hf.no

Locations
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Norway
Oslo Unviersity Hospital Recruiting
Oslo, Norway, 0424
Contact: Line Wisting, PhD    93495268    line.wisting@ous-hf.no   
Sponsors and Collaborators
Oslo University Hospital
Dam Foundation
Norwegian Diabetes Association
Investigators
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Principal Investigator: Line Wisting, PhD Oslo University Hospital, Division of Mental Health and Addiction
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Responsible Party: Line Wisting, Researcher, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT04837989    
Other Study ID Numbers: 6860
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Feeding and Eating Disorders
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Mental Disorders