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Prevention of Eating Disorders Through Optimization of Protective Factors

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05863598
Enrollment
644
Registered
2023-05-18
Start date
2023-05-15
Completion date
2027-12-31
Last updated
2025-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Dissatisfaction, Eating Disorders

Keywords

eating disorders, body dissatisfaction, risk factors, buffering factors, incidence, efficacy, cost-effectiveness

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.

Interventions

BEHAVIORALEnhancing 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.

BEHAVIORALExpressive writing

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

Sponsors

Uppsala University
CollaboratorOTHER
Linkoeping University
CollaboratorOTHER_GOV
Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

Randomization will be conducted using a randomization list. As soon as a participant is eligible after providing baseline data and a clinical interview, the assessment staff will ask the coordinator to check what condition the participant should be assigned to based on the randomization list. The participants will be informed. At follow-ups, the assessors will not be aware of the intervention condition of each participants.

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.

Eligibility

Sex/Gender
ALL
Age
15 Years to 20 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Incidence of eating disorders through the Eating disorders examination (EDE) (Fairburn, 2008, Guilford Press).Baseline to 36 months post-interventionThe 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

MeasureTime frameDescription
Change in body appreciation through the Body Appreciation Scale (BAS: Tylka & Wood-Bacalow, 2015, Body Image, 12, 53-67).From baseline, up to 36 months post-interventionThe 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.
Change in intuitive eating through the Intuitive Eating Scale (IES: Tylka & Kroon Van Diest, 2013, J Cons Psychol, 60,137-153).From baseline, up to 36 months post-interventionThe 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.
Change in self-compassion through the Self-Compassion Scale (SCS: Raes et al., 2011, Clin Psychol Psychother, 18, 250-255).From baseline, up to 36 months post-interventionThe 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.
Change in life values through the Bull's-Eye Values Survey (BE-VS: Lundgren et al, 2012, Cogn Behav Pract, 19, 518-526).From baseline, up to 36 months post-interventionThe 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.
Change in body dissatisfaction through the Body Shape questionnaire: BSQ (Welch et al, 2011: Beh Res Ther, 49, 85-91).From baseline, up to 36 months post-interventionThe 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.
Change in drive for muscularity through the Drive for Muscularity Scale (DMS: McCreary& Sasse, 2000, J Am Coll Health, 48, 297-304).From baseline, up to 36 months post-interventionThe 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.
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)From baseline, up to 36 months post-interventionThe 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.
Change in quality of life through The Brunnsviken Quality of Life Scale (BBQ: Lindner et al, 2016, Cogn Behav Ther, 45, 182-195).From baseline, up to 36 months post-interventionThe 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.
Change in body functionality appreciation through the Functionality Appreciation Scale (FAS: Alleva et al, 2017, Body Image, 23, 28-44).From baseline, up to 36 months post-interventionThe 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.
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).From baseline, up to 36 months post-interventionThe 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.

Other

MeasureTime frameDescription
Experience of stigma and iatrogenic effects through the Self-reported risk of stigma and iatrogenic effect.6-months post-interventionAny experience of stigma or iatrogenic effects related to the intervention/study will be investigated through specifically designed questions for the study.
Moderators of outcomes: Sex, Age, Socio-economic status.Baseline assessmentData 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.
Experience of stigma and iatrogenic effects through the Self-reported risk of stigma and iatrogenic effectPost-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

Countries

Sweden

Contacts

Primary ContactAta Ghaderi, PhD
ata.ghaderi@ki.se+46 8 524 832 48
Backup ContactThomas Parling, PhD
thomas.parling@ki.se+46 8 524 800 00

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026