Prevention of Eating Disorders Through Optimization of Protective Factors

NCT05863598 | Recruiting

• 1 other identifier: 2022-01039
• Study Type: interventional
• Target: 644
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of thin randomized controlled trial is to investigate the efficacy of a prevention program for reducing the incidence of eating disorders among youth (15-20). We target youth at these ages who experience a subjective sense of body dissatisfaction, and are thus at increased risk of developing an eating disorder. The prevention program is based on improving protective factors such as body appreciation, body image flexibility, intuitive eating, and acceptance. It will be compared to a credible placebo (expressive writing).

Conditions

Body Dissatisfaction; Eating Disorders

Keywords

eating disorders; body dissatisfaction; risk factors; buffering factors; incidence; efficacy; cost-effectiveness

Outcome Measures

Primary Outcomes (1)

• Incidence of eating disorders through the Eating disorders examination (EDE) (Fairburn, 2008, Guilford Press).

  The Eating disorders examination interview is the gold standard to establish diagnoses of eating disorders and will be used at baseline and to investigate the incidence of eating disorders (ED) during the follow-up period (36 months post intervention). Diagnostic status will be specified based on specific criteria for each ED diagnosis.

  Baseline to 36 months post-intervention

Secondary Outcomes (10)

• Change in body dissatisfaction through the Body Shape questionnaire: BSQ (Welch et al, 2011: Beh Res Ther, 49, 85-91).

  From baseline, up to 36 months post-intervention

• Change in drive for muscularity through the Drive for Muscularity Scale (DMS: McCreary& Sasse, 2000, J Am Coll Health, 48, 297-304).

  From baseline, up to 36 months post-intervention

• Change in the internalization of thin ideal through the Ideal Body Stereotype Scale-Revised (IBSS-R: Stice et al, 2008, J Consult Clin Pschol, 76, 329-340)

  From baseline, up to 36 months post-intervention

• Change in quality of life through The Brunnsviken Quality of Life Scale (BBQ: Lindner et al, 2016, Cogn Behav Ther, 45, 182-195).

  From baseline, up to 36 months post-intervention

• Change in body appreciation through the Body Appreciation Scale (BAS: Tylka & Wood-Bacalow, 2015, Body Image, 12, 53-67).

  From baseline, up to 36 months post-intervention

Other Outcomes (6)

• Moderators of outcomes: Sex, Age, Socio-economic status.

  Baseline assessment

• Experience of stigma and iatrogenic effects through the Self-reported risk of stigma and iatrogenic effect

  Post-intervention (i.e., 5 weeks after the start of intervention)

• Experience of stigma and iatrogenic effects through the Self-reported risk of stigma and iatrogenic effect.

  6-months post-intervention

Study Arms (2)

Enhancing protective factors

EXPERIMENTAL

Participants will learn to improve their body image through body appreciation tasks, body image flexibility and focus on body functionality appreciation. They also learn to focus on important life values, be more accepting of themselves, and learn to eat regularly and with attention to bodily needs and signals. This is don in interactive ways, and by using a cognitive dissonance frame.

Behavioral: Enhancing protective factors

Expressive writing

PLACEBO COMPARATOR

Participants will be instructed to write about any thoughts, feelings, images, memories, interceptions, ideas or emotions related to their body for the same during as the active intervention (i.e., 40 minutes/week across four consecutive weeks).

Behavioral: Expressive writing

Interventions

Enhancing protective factors BEHAVIORAL

Participants will watch some short movies and infographics, and will be asked to argue for the importance of body image flexibility, body functionality appreciation, etc.

Enhancing protective factors

Expressive writing BEHAVIORAL

Participants will reflect and write about any cognitions or emotions they can have in relation to their bodies.

Expressive writing

Eligibility Criteria

• Age: 15 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

Sponsors & Collaborators

• Karolinska Institutet: lead
• Uppsala University: collaborator
• Linkoeping University: collaborator

Study Sites (1)

Karolinska Institutet

Solna, 17177, Sweden

RECRUITING

Related Publications (11)

• 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

• Andrew R, Tiggemann M, Clark L. The protective role of body appreciation against media-induced body dissatisfaction. Body Image. 2015 Sep;15:98-104. doi: 10.1016/j.bodyim.2015.07.005. Epub 2015 Aug 24.

  PMID: 26311661 BACKGROUND

• Atkinson MJ, Wade TD. Mindfulness-based prevention for eating disorders: A school-based cluster randomized controlled study. Int J Eat Disord. 2015 Nov;48(7):1024-37. doi: 10.1002/eat.22416. Epub 2015 Jun 6.

  PMID: 26052831 BACKGROUND

• Burychka D, Miragall M, Banos RM. Towards a Comprehensive Understanding of Body Image: Integrating Positive Body Image, Embodiment and Self-Compassion. Psychol Belg. 2021 Jul 27;61(1):248-261. doi: 10.5334/pb.1057. eCollection 2021.

  PMID: 34394951 BACKGROUND

• Homan KJ, Tylka TL. Self-compassion moderates body comparison and appearance self-worth's inverse relationships with body appreciation. Body Image. 2015 Sep;15:1-7. doi: 10.1016/j.bodyim.2015.04.007. Epub 2015 May 16.

  PMID: 25978272 BACKGROUND

• Levine MP, Smolak L. The role of protective factors in the prevention of negative body image and disordered eating. Eat Disord. 2016;24(1):39-46. doi: 10.1080/10640266.2015.1113826. Epub 2015 Dec 7. No abstract available.

  PMID: 26643272 BACKGROUND

• Linardon J, Tylka TL, Fuller-Tyszkiewicz M. Intuitive eating and its psychological correlates: A meta-analysis. Int J Eat Disord. 2021 Jul;54(7):1073-1098. doi: 10.1002/eat.23509. Epub 2021 Mar 30.

  PMID: 33786858 BACKGROUND

• Mensinger JL, Granche JL, Cox SA, Henretty JR. Sexual and gender minority individuals report higher rates of abuse and more severe eating disorder symptoms than cisgender heterosexual individuals at admission to eating disorder treatment. Int J Eat Disord. 2020 Apr;53(4):541-554. doi: 10.1002/eat.23257. Epub 2020 Mar 13.

  PMID: 32167198 BACKGROUND

• Moffitt RL, Neumann DL, Williamson SP. Comparing the efficacy of a brief self-esteem and self-compassion intervention for state body dissatisfaction and self-improvement motivation. Body Image. 2018 Dec;27:67-76. doi: 10.1016/j.bodyim.2018.08.008. Epub 2018 Aug 23.

  PMID: 30144731 BACKGROUND

• Ahlen J, Hursti T, Tanner L, Tokay Z, Ghaderi A. Prevention of Anxiety and Depression in Swedish School Children: a Cluster-Randomized Effectiveness Study. Prev Sci. 2018 Feb;19(2):147-158. doi: 10.1007/s11121-017-0821-1.

  PMID: 28730396 BACKGROUND

• Koller KA, Thompson KA, Miller AJ, Walsh EC, Bardone-Cone AM. Body appreciation and intuitive eating in eating disorder recovery. Int J Eat Disord. 2020 Aug;53(8):1261-1269. doi: 10.1002/eat.23238. Epub 2020 Feb 5.

  PMID: 32020677 BACKGROUND

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Ata Ghaderi, PhD

  PI employed at Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ata Ghaderi, PhD

CONTACT

+46 8 524 832 48; ata.ghaderi@ki.se

Thomas Parling, PhD

CONTACT

+46 8 524 800 00; thomas.parling@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Randomization will be conducted using a randomization list. As soon as a participant is eligible after providing baseline data and a clinical interview, the assessment staff will ask the coordinator to check what condition the participant should be assigned to based on the randomization list. The participants will be informed. At follow-ups, the assessors will not be aware of the intervention condition of each participants.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is randomized controlled trials. Participants will be randomized to the active prevention program, or to a placebo (expressive writing). The intervention is brief (four weeks only). Recruitment of the participants (n=644) will take one year (anticipated)After the intervention, they will receive a booster session and will be followed up every 6 months, for 36 months post-intervention.

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 18, 2023
• Study Start: May 15, 2023
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 6, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)