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RecruitingNCT05863598

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
Phase
N/A
Study type
Interventional
Enrollment
644 (estimated)
Sponsor
Karolinska Institutet · Academic / Other
Sex
All
Age
15 Years – 20 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALEnhancing protective factorsParticipants 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 writingParticipants will reflect and write about any cognitions or emotions they can have in relation to their bodies.

Timeline

Start date
2023-05-15
Primary completion
2027-07-31
Completion
2027-12-31
First posted
2023-05-18
Last updated
2025-03-06

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT05863598. Inclusion in this directory is not an endorsement.