Prevention of Eating Disorders Through Optimization of Protective Factors

Official title

A Randomized Controlled Trial of an Interactive Non-Stigmatizing Intervention to Prevent Eating Disorders in Youths Through Strengthening of Protective Factors

Overview

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).

Detailed description

Research area and aims:

Eating disorders (EDs) are common and cause significant morbidity and mortality. Due to stigma, only 25% seek help and only 50% fully recover after receiving treatments. Large-scale prevention is urgently needed to reduce the emergence and burden of EDs at a population level. However, current prevention programs do not meet requirements for efficient and economically attractive large-scale implementation. The main aim of this project is to investigate the efficacy and cost-effectiveness of a scalable, brief, and interactive prevention program based on reinforcement of protective factors against EDs using a randomized controlled design. A focus on protective factors disrupts the processes by which risk factors increase the probability for EDs to emerge and minimizes the risks for stigmatization.

Research questions:

1. How effective is an internet-based prevention program, that reinforces protective factors against EDs, in reducing the onset of EDs 6, 12, 24, and 36 months post-intervention? 2. Does the intervention reduce the incidence of EDs through enhancement of specifically targeted protective factors (mediators)? 3. Is prevention of EDs based on reinforcement of protective factors cost-effective? 4. How do the participant experience their participation in these two interventions?

Other research questions concern gender differences in enrollment and compliance, potential moderators of outcome, participation in booster sessions, and potential risk for stigma.

Interventions

• Behavioral Enhancing protective factors
  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.
• Behavioral Expressive writing
  Participants will reflect and write about any cognitions or emotions they can have in relation to their bodies.

Primary outcome measures

• Incidence of eating disorders through the Eating disorders examination (EDE) (Fairburn, 2008, Guilford Press). [Time frame: Baseline to 36 months post-intervention]

Secondary outcome measures (10)

• Change in body dissatisfaction through the Body Shape questionnaire: BSQ (Welch et al, 2011: Beh Res Ther, 49, 85-91). [Time frame: 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). [Time frame: 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) [Time frame: 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). [Time frame: 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). [Time frame: From baseline, up to 36 months post-intervention]
• Change in body functionality appreciation through the Functionality Appreciation Scale (FAS: Alleva et al, 2017, Body Image, 23, 28-44). [Time frame: From baseline, up to 36 months post-intervention]
• Change in body image flexibility through the Body Image Acceptance and Action Questionnaire (BI-AAQ-5: Sandoz et al, 2013, J Cont Behav Science, 2, 39-48). [Time frame: From baseline, up to 36 months post-intervention]
• Change in intuitive eating through the Intuitive Eating Scale (IES: Tylka & Kroon Van Diest, 2013, J Cons Psychol, 60,137-153). [Time frame: From baseline, up to 36 months post-intervention]
• Change in self-compassion through the Self-Compassion Scale (SCS: Raes et al., 2011, Clin Psychol Psychother, 18, 250-255). [Time frame: From baseline, up to 36 months post-intervention]
• Change in life values through the Bull's-Eye Values Survey (BE-VS: Lundgren et al, 2012, Cogn Behav Pract, 19, 518-526). [Time frame: From baseline, up to 36 months post-intervention]

Eligibility criteria

Inclusion Criteria: Youth and young people (15-20 years) with a subjective experience of body dissatisfaction.

Exclusion Criteria: Indications of depression, or suicidality, as well as presence of an eating disorder, or other conditions that may require medical attention, or conditions that makes it impossible to complete the intervention (e.g., not being able to read and write in Swedish).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

Sweden · 1 center

• Karolinska Institutet — Solna

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT05863598 · 2022-01039

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗