Prevention of Eating Disorders Through Optimization of Protective Factors

March 4, 2025 updated by: Ata Ghaderi, Karolinska Institutet

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

644

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
      • Solna, Sweden, 17177
        • Recruiting
        • Karolinska Institutet
        • Contact:
        • Contact:
          • Ata Ghaderi, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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).
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.
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
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)
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.
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
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).
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.
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
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).
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.
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
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).
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.
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
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline assessment
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
Post-intervention (i.e., 5 weeks after the start of intervention)
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.
6-months post-intervention
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.
12-months post-intervention
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.
24-months post-intervention
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.
36-months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Uppsala University
Linkoeping University

Investigators

  • Principal Investigator: Ata Ghaderi, PhD, PI employed at Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2023

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

April 28, 2023

First Submitted That Met QC Criteria

May 8, 2023

First Posted (Actual)

May 18, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 4, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-01039

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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