Prevention of Eating Disorders Through Optimization of Protective Factors

Karolinska Institute

Status: Enrolling

Conditions: Eating Disorders; Body Dissatisfaction

Treatments: Behavioral: Enhancing protective factors; Behavioral: Expressive writing

Study type: Interventional

Funder types: Other

Identifiers

NCT05863598

2022-01039

Details and patient eligibility

About

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).

Full 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.

Enrollment: 644 estimated patients

Sex: All

Ages: 15 to 20 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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644 participants in 2 patient groups, including a placebo group

Enhancing protective factors

Experimental group

Description:

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.

Treatment:

Behavioral: Enhancing protective factors

Expressive writing

Placebo Comparator group

Description:

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).

Treatment:

Behavioral: Expressive writing