Prevention of Eating Disorders Through Optimization of Protective Factors

Study Overview
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Brief Summary
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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
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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: 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? Does the intervention reduce the incidence of EDs through enhancement of specifically targeted protective factors (mediators)? Is prevention of EDs based on reinforcement of protective factors cost-effective? 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.

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

Conditions
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Body Dissatisfaction, Eating Disorders

Intervention / Treatment
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* Behavioral: Enhancing protective factors
* Behavioral: Expressive writing


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhancing protective factors<br>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<br>* 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.<br>|
| Placebo Comparator: Expressive writing<br>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<br>* Participants will reflect and write about any cognitions or emotions they can have in relation to their bodies.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 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. | 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) | 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. | 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). | 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. | 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). | The Body Appreciation Scale (10 items) has good psychometrics. The items are scored on a scale from 1 to 5. Higher scores indicate more body appreciation. | 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). | The Functionality Appreciation Scale (7 items) has good psychometrics. Items are rated on a scale from 1 to 5. Higher scores indicate higher appreciation of body functionality. | 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). | The Body Image Acceptance and Action Questionnaire measures body image flexibility (5 items), which is another protective factor. Items are rated on a scale from 1 to 7. Higher scores indicate more body image flexibility. | 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). | The Intuitive Eating Scale (23 items) is an established measure of intuitive eating. It has good psychometric properties. Items are rated on a scale from 1 to 5. Higher scores indicate more intuitive eating. | 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). | The Self-Compassion Scale (Brief version: 12 items) has good psychometrics. It provides information on an important protective factor. Items are rated on a scale from 1 to 5. Higher scores indicate higher self-compassion. | 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). | The Bull's-Eye Values Survey helps to ascertain what ares in life (i.e., personal values) seem important to each participant. It has been adapted by providing the instructions through a brief instructional video instead of lengthy text. The importance of life directions are rated on a scale from 0 to 7. Higher scores indicate more importance. The proximity to life values is rated on a scale from 1 to 7. Higher scores indicate more proximity, where 7 is the bull's eye. | From baseline, up to 36 months post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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eating disorders, body dissatisfaction, risk factors, buffering factors, incidence, efficacy, cost-effectiveness