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NCT Number: NCT05863598

Prevention of Eating Disorders Through Optimization of Protective Factors

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).

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Key information

Conditions

Body Dissatisfaction Eating Disorders Feeding and Eating Disorders Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

15 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet

Solna, 17177, Sweden

Location status: Recruiting

Location contact

Ata Ghaderi, PhD

CONTACT

[email protected]

+46-8-524 832 48

Ata Ghaderi, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Expressive writing

Behavioral

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

Primary outcomes

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

    Time frame: Baseline to 36 months post-intervention

    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.

Secondary outcomes

  1. 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

    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.

  2. 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

    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.

  3. 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

    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.

  4. 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

    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.

  5. 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

    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.

  6. 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

    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.

  7. 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

    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.

  8. 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

    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.

  9. 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

    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.

  10. 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

    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.

Other outcomes

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

    Time frame: Baseline assessment

    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.

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

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

    Any experience of stigma or iatrogenic effects related to the intervention/study will be investigated through specifically designed questions for the study

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

    Time frame: 6-months post-intervention

    Any experience of stigma or iatrogenic effects related to the intervention/study will be investigated through specifically designed questions for the study.

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

    Time frame: 12-months post-intervention

    Any experience of stigma or iatrogenic effects related to the intervention/study will be investigated through specifically designed questions for the study.

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

    Time frame: 24-months post-intervention

    Any experience of stigma or iatrogenic effects related to the intervention/study will be investigated through specifically designed questions for the study.

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

    Time frame: 36-months post-intervention

    Any experience of stigma or iatrogenic effects related to the intervention/study will be investigated through specifically designed questions for the study.

Study contacts

Contact information is provided by the study sponsor or research team.

Ata Ghaderi, PhD

CONTACT

[email protected]

+46 8 524 832 48

Thomas Parling, PhD

CONTACT

[email protected]

+46 8 524 800 00

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Linkoeping University
  • Uppsala University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 18, 2023
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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