Prevention of Eating Disorders Through Optimization of Protective Factors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-20
SponsorKarolinska Institutet
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Enhancing protective factors
BehavioralParticipants will watch some short movies and infographics, and will be asked to argue for the importance of body image flexibility, body functionality appreciation, etc.
Expressive writing
BehavioralParticipants will reflect and write about any cognitions or emotions they can have in relation to their bodies.
Treatment groups
644 Participants
are divided into 2 treatment groupsGroup A: Enhancing protective factorsExperimental treatment 1 intervention
Group B: Expressive writingPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline to 36 months post-interventionSecondary outcomes
1
Change in body dissatisfaction through the Body Shape questionnaire: BSQ (Welch et al, 2011: Beh Res Ther, 49, 85-91).
The Body Shape questionnaire (Brief version: 8 items) measures body dissatisfaction. It has good psychometric properties. Items are scored on a Likert-type scale from 1 (Never) to 6 (Always). Higher scores indicate more body dissatisfaction.
Time frame
From baseline, up to 36 months post-intervention2
Change in drive for muscularity through the Drive for Muscularity Scale (DMS: McCreary& Sasse, 2000, J Am Coll Health, 48, 297-304).
The Drive for Muscularity Scale (15 items) measures one of the risk factors for ED. It has good psychometrics. Items are rated on a scale from 1 to 6. Higher scores indicate stronger drive for muscularity.
Time frame
From baseline, up to 36 months post-intervention3
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)
The Body Stereotype Scale-Revised (6 items) measures the internalization of the current thinness ideal, which is a risk factors for ED. It has good psychometrics. Items are rated on a scale from 1 to 5. Higher scores indicate more internalization of the thin ideal.
Time frame
From baseline, up to 36 months post-intervention4
Change in quality of life through The Brunnsviken Quality of Life Scale (BBQ: Lindner et al, 2016, Cogn Behav Ther, 45, 182-195).
The Brunnsviken Quality of Life Scale is a brief instrument (12 items) developed in Sweden with good psychometrics to measure quality of life. The items are rated on a scale from 0 to 4. Higher scores indicate stronger satisfaction with life.
Time frame
From baseline, up to 36 months post-interventionOther outcomes
1
Moderators of outcomes: Sex, Age, Socio-economic status.
Data on sex (Male or Female), age (15-20) and socioeconomic status (level of education) will be used to investigate whether they moderated the rate of enrollment, compliance (how many modules of the program they complete), and outcome.
Time frame
Baseline assessment2
Experience of stigma and iatrogenic effects through the Self-reported risk of stigma and iatrogenic effect
Any experience of stigma or iatrogenic effects related to the intervention/study will be investigated through specifically designed questions for the study
Time frame
Post-intervention (i.e., 5 weeks after the start of intervention)3
Experience of stigma and iatrogenic effects through the Self-reported risk of stigma and iatrogenic effect.
Any experience of stigma or iatrogenic effects related to the intervention/study will be investigated through specifically designed questions for the study.
Time frame
6-months post-intervention4
Experience of stigma and iatrogenic effects through the Self-reported risk of stigma and iatrogenic effect.
Any experience of stigma or iatrogenic effects related to the intervention/study will be investigated through specifically designed questions for the study.
Time frame
12-months post-interventionSponsors and contacts
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Source ClinicalTrials.gov