Body Project SMIL: Prevention of Eating Disorders Among Young Women With Psychiatric Illness With the Body Project

NCT06893627 | Not Yet Recruiting DMC

• 1 other identifier: 1-10-72-71-24
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Eating Disorders; Psychiatric Disorder; Body Dissatisfaction; Eating Disorder Symptom and Body Image Dissatisfaction

Keywords

Prevention of eating disorders; Dissonance-based prevention; psychiatric ilness

Outcome Measures

Primary Outcomes (1)

• Eating Disorders

  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.

  Baseline, 1 year and 2 years

Secondary Outcomes (17)

• Eating Disorder symptoms

  Baseline, 1 month, 1/2 year, 1 year, 2 years

• Eating Disorder symptoms

  Baseline, 1 month, 1/2 year, 1 year, 2 years

• Thin-idealization

  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

• Overevaluation og appearence, weight and shape

  Baseline, 1 month, 1/2 year, 1 year, 2 years

Study Arms (2)

Body Project intervention

EXPERIMENTAL

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

Behavioral: Body Project

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.

Behavioral: Expressive writing

Interventions

Body Project BEHAVIORAL

Dissonance-based, online, peed-led eating disorder prevention intervention, consisting of 4 x 1 hour with a week a part.

Body Project intervention

Expressive writing BEHAVIORAL

Participants are encouraged to write about their body 40 min. per week

Expressive writing

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aarhus University Hospital: lead
• Aalborg Psychiatric Hospital: collaborator

Study Sites (1)

Aarhus University Hospital Psychiatry

Aarhus, 8200, Denmark

Location

Related Publications (29)

• Van Strien, T., et al., The predictive validity of the Dutch restrained eating scale. International journal of eating disorders, 1986. 5(4): p. 747-755.

  BACKGROUND

• Wilfley DE, Schwartz MB, Spurrell EB, Fairburn CG. Assessing the specific psychopathology of binge eating disorder patients: interview or self-report? Behav Res Ther. 1997 Dec;35(12):1151-9.

  PMID: 9465449 BACKGROUND

• Byrd-Bredbenner C, Eck K, Quick V. GAD-7, GAD-2, and GAD-mini: Psychometric properties and norms of university students in the United States. Gen Hosp Psychiatry. 2021 Mar-Apr;69:61-66. doi: 10.1016/j.genhosppsych.2021.01.002. Epub 2021 Jan 9.

  PMID: 33571925 BACKGROUND

• Reas DL, Ro O, Kapstad H, Lask B. Psychometric properties of the clinical impairment assessment: norms for young adult women. Int J Eat Disord. 2010 Jan;43(1):72-6. doi: 10.1002/eat.20653.

  PMID: 19260038 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The Patient Health Questionnaire-2: validity of a two-item depression screener. Med Care. 2003 Nov;41(11):1284-92. doi: 10.1097/01.MLR.0000093487.78664.3C.

  PMID: 14583691 BACKGROUND

• Hovmand OR, Reinholt N, Christensen AB, Eskildsen A, Bach B, Arendt M, Poulsen S, Hvenegaard M, Arnfred SM. Affectivity in danish patients with emotional disorders: assessing the validity of the Positive and Negative Affect Schedule (PANAS). BMC Psychiatry. 2023 Dec 13;23(1):943. doi: 10.1186/s12888-023-05450-z.

  PMID: 38093282 BACKGROUND

• Andersen S, Davidsen M, Nielsen L, Tolstrup JS. Mental health groups in high school students and later school dropout: a latent class and register-based follow-up analysis of the Danish National Youth Study. BMC Psychol. 2021 Aug 18;9(1):122. doi: 10.1186/s40359-021-00621-7.

  PMID: 34407891 BACKGROUND

• Franke GH, Jaeger S, Glaesmer H, Barkmann C, Petrowski K, Braehler E. Psychometric analysis of the brief symptom inventory 18 (BSI-18) in a representative German sample. BMC Med Res Methodol. 2017 Jan 26;17(1):14. doi: 10.1186/s12874-016-0283-3.

  PMID: 28125960 BACKGROUND

• Weissman MM, Bothwell S. Assessment of social adjustment by patient self-report. Arch Gen Psychiatry. 1976 Sep;33(9):1111-5. doi: 10.1001/archpsyc.1976.01770090101010.

  PMID: 962494 BACKGROUND

• Stice E, Shaw H, Becker CB, Rohde P. Dissonance-based Interventions for the prevention of eating disorders: using persuasion principles to promote health. Prev Sci. 2008 Jun;9(2):114-28. doi: 10.1007/s11121-008-0093-x. Epub 2008 May 28.

  PMID: 18506621 BACKGROUND

• Wisting L, Haugvik S, Wennersberg AL, Hage TW, Stice E, Olmsted MP, Ghaderi A, Brunborg C, Skrivarhaug T, Dahl-Jorgensen K, Ro O. Feasibility of a virtually delivered eating disorder prevention program for young females with type 1 diabetes. Int J Eat Disord. 2021 Sep;54(9):1696-1706. doi: 10.1002/eat.23578. Epub 2021 Jul 10.

  PMID: 34245038 BACKGROUND

• Stice E, Rohde P, Shaw H, Gau JM. Clinician-led, peer-led, and internet-delivered dissonance-based eating disorder prevention programs: Effectiveness of these delivery modalities through 4-year follow-up. J Consult Clin Psychol. 2020 May;88(5):481-494. doi: 10.1037/ccp0000493. Epub 2020 Feb 24.

  PMID: 32091226 BACKGROUND

• Festinger, L., A theory of cognitive dissonance. A theory of cognitive dissonance. 1957: Stanford University Press. xi, 291-xi, 291.

  BACKGROUND

• Stice, E., P. Rohde, and H. Shaw, The Body Project: A Dissonance-Based Eating Disorder Prevention Intervention. 2012: Oxford University Press.

  BACKGROUND

• Stice E, Onipede ZA, Marti CN. A meta-analytic review of trials that tested whether eating disorder prevention programs prevent eating disorder onset. Clin Psychol Rev. 2021 Jul;87:102046. doi: 10.1016/j.cpr.2021.102046. Epub 2021 May 21.

  PMID: 34048952 BACKGROUND

• Ghaderi A, Stice E, Andersson G, Eno Persson J, Allzen E. A randomized controlled trial of the effectiveness of virtually delivered Body Project (vBP) groups to prevent eating disorders. J Consult Clin Psychol. 2020 Jul;88(7):643-656. doi: 10.1037/ccp0000506.

  PMID: 32551736 BACKGROUND

• Barakat S, McLean SA, Bryant E, Le A, Marks P; National Eating Disorder Research Consortium; Touyz S, Maguire S. Risk factors for eating disorders: findings from a rapid review. J Eat Disord. 2023 Jan 17;11(1):8. doi: 10.1186/s40337-022-00717-4.

  PMID: 36650572 BACKGROUND

• Momen NC, Plana-Ripoll O, Yilmaz Z, Thornton LM, McGrath JJ, Bulik CM, Petersen LV. Comorbidity between eating disorders and psychiatric disorders. Int J Eat Disord. 2022 Apr;55(4):505-517. doi: 10.1002/eat.23687. Epub 2022 Jan 27.

  PMID: 35084057 BACKGROUND

• Conviser JH, Fisher SD, McColley SA. Are children with chronic illnesses requiring dietary therapy at risk for disordered eating or eating disorders? A systematic review. Int J Eat Disord. 2018 Mar;51(3):187-213. doi: 10.1002/eat.22831. Epub 2018 Feb 22.

  PMID: 29469935 BACKGROUND

• Ottesen MA, A.A., Dahl KM, Lausten M, Boe Rayce S, Bille Tagmose B, BØRN OG UNGE I DANMARK - VELFÆRD OG TRIVSEL 2022. 2022.

  BACKGROUND

• Austin A, Flynn M, Richards K, Hodsoll J, Duarte TA, Robinson P, Kelly J, Schmidt U. Duration of untreated eating disorder and relationship to outcomes: A systematic review of the literature. Eur Eat Disord Rev. 2021 May;29(3):329-345. doi: 10.1002/erv.2745. Epub 2020 Jun 23.

  PMID: 32578311 BACKGROUND

• Helverskov JL, Clausen L, Mors O, Frydenberg M, Thomsen PH, Rokkedal K. Trans-diagnostic outcome of eating disorders: A 30-month follow-up study of 629 patients. Eur Eat Disord Rev. 2010 Nov-Dec;18(6):453-63. doi: 10.1002/erv.1025.

  PMID: 20593480 BACKGROUND

• Hay P. A systematic review of evidence for psychological treatments in eating disorders: 2005-2012. Int J Eat Disord. 2013 Jul;46(5):462-9. doi: 10.1002/eat.22103.

  PMID: 23658093 BACKGROUND

• Wonderlich SA, Peterson CB, Crosby RD, Smith TL, Klein MH, Mitchell JE, Crow SJ. A randomized controlled comparison of integrative cognitive-affective therapy (ICAT) and enhanced cognitive-behavioral therapy (CBT-E) for bulimia nervosa. Psychol Med. 2014 Feb;44(3):543-53. doi: 10.1017/S0033291713001098. Epub 2013 May 23.

  PMID: 23701891 BACKGROUND

• Solmi M, Radua J, Olivola M, Croce E, Soardo L, Salazar de Pablo G, Il Shin J, Kirkbride JB, Jones P, Kim JH, Kim JY, Carvalho AF, Seeman MV, Correll CU, Fusar-Poli P. Age at onset of mental disorders worldwide: large-scale meta-analysis of 192 epidemiological studies. Mol Psychiatry. 2022 Jan;27(1):281-295. doi: 10.1038/s41380-021-01161-7. Epub 2021 Jun 2.

  PMID: 34079068 BACKGROUND

• Klump KL, Bulik CM, Kaye WH, Treasure J, Tyson E. Academy for eating disorders position paper: eating disorders are serious mental illnesses. Int J Eat Disord. 2009 Mar;42(2):97-103. doi: 10.1002/eat.20589. No abstract available.

  PMID: 18951455 BACKGROUND

• Stice E, Marti CN, Rohde P. Prevalence, incidence, impairment, and course of the proposed DSM-5 eating disorder diagnoses in an 8-year prospective community study of young women. J Abnorm Psychol. 2013 May;122(2):445-57. doi: 10.1037/a0030679. Epub 2012 Nov 12.

  PMID: 23148784 BACKGROUND

• Koreshe E, Paxton S, Miskovic-Wheatley J, Bryant E, Le A, Maloney D; National Eating Disorder Research Consortium; Touyz S, Maguire S. Prevention and early intervention in eating disorders: findings from a rapid review. J Eat Disord. 2023 Mar 10;11(1):38. doi: 10.1186/s40337-023-00758-3.

  PMID: 36899428 BACKGROUND

• Arcelus J, Mitchell AJ, Wales J, Nielsen S. Mortality rates in patients with anorexia nervosa and other eating disorders. A meta-analysis of 36 studies. Arch Gen Psychiatry. 2011 Jul;68(7):724-31. doi: 10.1001/archgenpsychiatry.2011.74.

  PMID: 21727255 BACKGROUND

Related Links

• Body Project website including participant information

MeSH Terms

Conditions

Feeding and Eating Disorders; Mental Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Loa Clausen, PhD

  Aarhus University Hospital Psychiatry

  PRINCIPAL INVESTIGATOR

• Caroline B Abild, Cl. dietician

  Aarhus University Hospital Psychiatry

  STUDY DIRECTOR

Central Study Contacts

Loa Clausen, PhD

CONTACT

+4521498646; loaclaus@rm.dk

Caroline B Abild, Cl. dietician

CONTACT

+4561706531; carocr@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Prof. Psychologist, PhD, senior researcher

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 25, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)