Clinical trial NCT05863598: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Body Dissatisfaction
Eating Disorders
Keywords: eating disorders
body dissatisfaction
risk factors
buffering factors
incidence
efficacy
cost-effectiveness
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Uppsala University
name: Linkoeping University
First posted: 2023-05-18
Enrollment: 644
Sex: ALL
Minimum age (years): 15
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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).

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.

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).

Primary outcomes:
measure: Incidence of eating disorders through the Eating disorders examination (EDE) (Fairburn, 2008, Guilford Press).
timeFrame: Baseline to 36 months post-intervention
Secondary outcomes:
measure: Change in body dissatisfaction through the Body Shape questionnaire: BSQ (Welch et al, 2011: Beh Res Ther, 49, 85-91).
timeFrame: From baseline, up to 36 months post-intervention
measure: Change in drive for muscularity through the Drive for Muscularity Scale (DMS: McCreary& Sasse, 2000, J Am Coll Health, 48, 297-304).
timeFrame: From baseline, up to 36 months post-intervention
measure: 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)
timeFrame: From baseline, up to 36 months post-intervention
measure: Change in quality of life through The Brunnsviken Quality of Life Scale (BBQ: Lindner et al, 2016, Cogn Behav Ther, 45, 182-195).
timeFrame: From baseline, up to 36 months post-intervention
measure: Change in body appreciation through the Body Appreciation Scale (BAS: Tylka & Wood-Bacalow, 2015, Body Image, 12, 53-67).
timeFrame: From baseline, up to 36 months post-intervention
measure: Change in body functionality appreciation through the Functionality Appreciation Scale (FAS: Alleva et al, 2017, Body Image, 23, 28-44).
timeFrame: From baseline, up to 36 months post-intervention
measure: 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).
timeFrame: From baseline, up to 36 months post-intervention
measure: Change in intuitive eating through the Intuitive Eating Scale (IES: Tylka & Kroon Van Diest, 2013, J Cons Psychol, 60,137-153).
timeFrame: From baseline, up to 36 months post-intervention
measure: Change in self-compassion through the Self-Compassion Scale (SCS: Raes et al., 2011, Clin Psychol Psychother, 18, 250-255).
timeFrame: From baseline, up to 36 months post-intervention
measure: Change in life values through the Bull's-Eye Values Survey (BE-VS: Lundgren et al, 2012, Cogn Behav Pract, 19, 518-526).
timeFrame: From baseline, up to 36 months post-intervention
Other outcomes:
measure: Moderators of outcomes: Sex, Age, Socio-economic status.
timeFrame: Baseline assessment
measure: Experience of stigma and iatrogenic effects through the Self-reported risk of stigma and iatrogenic effect
timeFrame: Post-intervention (i.e., 5 weeks after the start of intervention)
measure: Experience of stigma and iatrogenic effects through the Self-reported risk of stigma and iatrogenic effect.
timeFrame: 6-months post-intervention
measure: Experience of stigma and iatrogenic effects through the Self-reported risk of stigma and iatrogenic effect.
timeFrame: 12-months post-intervention
measure: Experience of stigma and iatrogenic effects through the Self-reported risk of stigma and iatrogenic effect.
timeFrame: 24-months post-intervention
measure: Experience of stigma and iatrogenic effects through the Self-reported risk of stigma and iatrogenic effect.
timeFrame: 36-months post-intervention
Locations:
city: Solna
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: PI employed at Karolinska Institutet
name: Ata Ghaderi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.