Clinical trial NCT05993728: Virtual Body Project Groups Led by Peers Versus Clinicians
Official title: Effectiveness of the Body Project to Prevent Eating Disorders in Young Females at Risk: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Eating Disorders
Body Image
Keywords: Prevention
Body acceptance
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: Stanford University
name: Oslo New University College, Norway
First posted: 2023-08-15
Enrollment: 441
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Eating disorders (EDs) are a group of illnesses associated with significant psychological and physiological consequences. Overall, only 20% of individuals with EDs receive treatment and treatment is effective for only about 25-35% for those who receive care. The development and implementation of effective prevention approaches for those at risk is therefore pivotal. The Body Project is the most effective ED prevention program for at-risk females according to meta-analyses, but reach has been limited since delivery has traditionally been in-person. Further research is warranted to examine cost-effective and easily accessible approaches to increase scalability and potential for broad implementation. With this application, the investigators therefore propose to examine the effectiveness of the Body Project in young females, a high-risk group, with the following main novel aspects: i) virtually-delivered Body Project groups to maximize reach; ii) peer-led versus clinician-led virtually-delivered Body Project groups; iii) the inclusion of objective measures to assess engagement of intervention targets (i.e., mediator).


Eligibility criteria: Inclusion Criteria:

* Age 16-25
* Female identifying
* Self-reported body image concerns

Exclusion Criteria:

* Ongoing eating disorder diagnosis requiring treatment or hospitalization

Primary outcomes:
measure: Change over time in eating disorder symptoms
timeFrame: Baseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-years
measure: Rate of eating disorder onset
timeFrame: Baseline/pretest, 1-year, and at 2-years
measure: Change over time in Body dissatisfaction
timeFrame: Baseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-years
measure: Change over time in thin-ideal internalization
timeFrame: Baseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-years
measure: Negative affect
timeFrame: Baseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-years
Secondary outcomes:
measure: Change over time in appearance ideals and perceived pressures
timeFrame: Baseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-years
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Line Wisting, PhD
role: PRINCIPAL_INVESTIGATOR
References: