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Clinical Trials/NCT06893627
NCT06893627Not yet recruitingNot Applicable

Body Project SMIL: Effectiveness of Virtually Delivered Body Project Groups to Prevent Eating Disorders Among Young Women With Psychiatric Illness

Aarhus University Hospital1 site in 1 country300 target enrollmentStarted: April 1, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
300
Locations
1
Primary Endpoint
Eating Disorders

Study Overview

Brief Summary

The Body Project SMIL tests the effectiveness of a virtual, peer-led intervention aimed at reducing body dissatisfaction and preventing eating disorders in young women with psychiatric illnesses.

Eating disorders like anorexia, bulimia, and binge eating disorder have severe physical and mental health consequences. Young women with psychiatric disorders face a fourfold higher risk, yet no widely implemented prevention programs exist in Denmark. Body Project SMIL addresses this gap by testing whether a structured online intervention can prevent eating disorders before they develop.

The study is open to women aged 15-25 with body dissatisfaction and a verified psychiatric diagnosis (e.g., mood disorders, anxiety, ADHD, or personality disorders). Those with a clinical eating disorder diagnosis are not eligible. Participants must be comfortable engaging in online group discussions.

Participants are randomly assigned to one of two groups:

Body Project Group - A peer-led, virtual program with four one-hour sessions focusing on challenging beauty ideals through structured exercises.

Expressive Writing Group - A self-guided exercise where participants write about body image for four weeks.

Assessments take place before and after the intervention, with follow-ups at six months, one year, and two years tracking body dissatisfaction, eating disorder symptoms, and well-being.

The Body Project is a proven intervention that reduces body dissatisfaction, thin-ideal internalization, and eating disorder symptoms, with some studies showing a 77% reduction in eating disorder risk. While tested in various settings, this study is the first to evaluate its impact on young women with psychiatric illnesses.

Participation benefits may include improved body image, reduced eating disorder risk, and enhanced self-esteem. The group format provides a supportive environment for sharing experiences and fostering healthier attitudes toward body image.

Ethical approval has been granted, ensuring compliance with GDPR regulations. Since this is a preventive program, it does not replace clinical treatment. Participants showing signs of an active eating disorder will be referred for appropriate care.

Recruitment occurs through psychiatric departments, educational institutions, and social media. A research website (www.bodyproject.dk) provides study details and a secure registration form. Parental consent is required for participants under 18, and all participants may withdraw at any time without consequences.

Conducted by Aarhus University Hospital Psychiatry in collaboration with international experts, this research may inform scalable prevention programs for young people at risk of eating disorders.

Detailed Description

Body Project SMIL:

Effectiveness of virtually delivered Body Project groups to prevent Eating Disorders among young Women with Psychiatric Illness (part of Body Project DK)

Background:

Eating disorders (ED) are characterized by extreme fear of weight gain, dietary restraint, binge eating, and compensatory behaviors such as self-induced vomiting, excessive exercise, and misuse of laxatives and diuretics with the main diagnostic categories being anorexia nervosa, bulimia nervosa, and binge eating disorder (DSM-5).

ED's are associated with functional impairment, reduced Quality-of-life, increased co-morbidity and mortality. Peak incidences for most ED are between the ages of 16 to 20 indicating that ED prevention initiatives should be implemented within this specific age group.

Study Design

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

Eligibility Criteria

Ages
15 Years to 25 Years (Child, Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •self-reported body dissatisfaction and a medically verified psychiatric diagnosis (e.g., mood disorders, anxiety disorders, ADHD, and personality disorders)

Exclusion Criteria

  • •ED symptoms equivalent to clinically significant ED corresponding to a diagnostic level according to DSM-5 criteria as evaluated via the Eating Disorder Diagnostic Interview.
  • •Acute psychiatric instability or psychosis or suicide attempt within the last 12 months, or inability to cognitively understand the project or work in the online group setting either due to illness or severe substance abuse.
  • •Not speaking and understanding Danish.

Arms & Interventions

Body Project intervention

Experimental

Dissonance-based, online, peed-led intervetion, consisting of 4 x 1 hour with a week a part.

Intervention: Body Project (Behavioral)

Expressive writing

Active Comparator

The expressive writing as the active control condition, will consist of written instructions sent to participants weekly over 4 weeks, asking them to write about their own thoughts or feelings in relation to their body for 40 min.

Intervention: Expressive writing (Behavioral)

Outcomes

Primary Outcomes

Eating Disorders

Time Frame: Baseline, 1 year and 2 years

Prevalence of clinical eating disorders. The semi-structured Eating Disorder Diagnostic Interview (EDDI) assesses ED symptoms including binge eating and purging corresponding to DSM-5 ED diagnoses, and will be used to determine anorexia nervosa, bulimia nervosa, binge eating disorder, and purging disorder. EDDI is a structured diagnostic interview assessing DSM-5 eating disorder criteria, yielding presence/absence of diagnoses and symptom frequency/severity.

Secondary Outcomes

  • Eating Disorder symptoms(Baseline, 1 month, 1/2 year, 1 year, 2 years)
  • Anxiety symptoms(Baseline, 1 month, 1/2 year, 1 year, 2 years)
  • Sleep problems(Baseline, 1 month, 1/2 year, 1 year, 2 years)
  • Depression symptoms(Baseline, 1 month, 1/2 year, 1 year, 2 years)
  • Body Dissatisfaction and overevaulation of body and shape(Baseline, 1 month, 1/2 year, 1 year, 2 years)
  • Positive and Negative affect(Baseline, 1 month, 1/2 year, 1 year, 2 years)
  • Stress(Baseline, 1 month, 1/2 year, 1 year, 2 years)
  • Thin-idealization(Baseline, 1 month, 1/2 year, 1 year, 2 years)
  • Overevaluation og appearence, weight and shape(Baseline, 1 month, 1/2 year, 1 year, 2 years)
  • Substance use(Baseline, 1 month, 1/2 year, 1 year, 2 years)
  • Loneliness(Baseline, 1 month, 1/2 year, 1 year, 2 years)
  • Functional Impairment(Baseline, 1 month, 1/2 year, 1 year, 2 years)
  • Psychological distress(Baseline, 1 month, 1/2 year, 1 year, 2 years)
  • Physical activity(Baseline, 1 month, 1/2 year, 1 year, 2 years)
  • Social media use(Baseline, 1 month, 1/2 year, 1 year, 2 years)
  • Health Care Utilization(Baseline, 1 year and 2 years)

Investigators

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

Loa Clausen

Ass. Prof. Psychologist, PhD, senior researcher

Aarhus University Hospital

Study Sites (1)

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