Clinical trial NCT05977582: Online Prevention Program for Eating Disorders Applied to College Students. Spanish Validation of the eBodyProject
Official title: Prevention Program for Eating Disorders Applied to College Students Using a Virtual Platform. Spanish Validation of the eBodyProject
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Eating Disorders
Keywords: Prevention
College women
Thin-ideal internalization
Lead sponsor: University of Barcelona
Sponsor class: OTHER
Collaborators: name: University of Burgos
First posted: 2023-08-04
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to analyze and compare in female college women two prevention programs for eating disorders, the Spanish Version of the eBodyProject and a traditional/educational prevention program. The main question it aims to answer is:

• The Spanish Version of the eBodyProject (intervention group) is more effective to prevent the onset of eating disorders with college students than a traditional psychological and educational prevention program (control group).

Participants will have to complete two main phases: assessment (pre- prevention program) and conducting the eBodyProject or traditional prevention program. The duration of the program is 4 weeks.

If there is a comparison group: Researchers will compare the Spanish eBodyProject Group with the traditional group to see and compare the effectiveness of each intervention arm.

Detailed description: The main objective of this project is to validate the Spanish version of the eating disorder prevention program, eBodyProject, proving its effectiveness through its application in a female university population. A comparison will be made with a standard ACT reporting program.

The following specific objectives are proposed:

* Identify and analyze the risk factors for eating disorders in the university population
* Analyze the evolution of ED risk factors throughout the prevention program for each group (pre- and post-intervention).
* Analyze the differences between groups (eBodyProject vs. standard treatment) of the risk factors for eating disorders throughout the prevention program (pre- and post-intervention).
* Analyze long-term efficacy through follow-ups at 1, 3 and 6 months from the end of the program for both groups.
* Analyze adherence and satisfaction with the program.

What does the study involve?

eBodyProject Intervention

The Spanish adaptation of the eBodyProject program will be modified (Stice et al., 2012b). This program consists of 4 modules adapted from the most recent version of the original program The Body Project, presented by the original authors who have given their consent and suggestions for the realization of the Spanish version.

The activities proposed through the different modules will be in written format or behavioral activities aimed at criticizing the ideal of feminine beauty imposed by today's society and promoting self-acceptance. Specifically, each module pursues the following objectives:

* Module 1: Origin and definition of the ideal of beauty; Examine the costs of pursuing the beauty ideal
* Module 2: Explore and learn different ways of resisting pressure to pursue the ideal of beauty
* Module 3: Learning to manage and face our own concerns about appearance and cultural pressures on thinness
* Module 4: Learn new and more positive ways to talk about one's appearance Each module will be carried out independently, following the instructions provided in the web space. The time available to carry out each module will be one week, with an average duration of 40-45 minutes per module. Participants will receive feedback from the professional within the first 2-3 days after the completion of each module. For the promotion of participation, 1 day before the start of the module and 2 days before its completion will be remembered.

Psychoeducational intervention for group control

Participants in this group will receive a weekly newsletter with information about the beauty ideal, the costs of pursuing it, and tips for resisting the pressure to pursue this ideal, as well as tips for managing the emotions associated with it. However, they will not have to perform exercises related to this information, a psychoeducational intervention. Once the study is finished, these participants will receive an email again in case they are interested in taking part in the eBodyProject prevention program.

What are the possible benefits or risk for the participants?

Benefits

* Validation in a Spanish sample of a prevention program that has presented positive results in other countries for the university population. Therefore, the possibility of having a preventive tool for eating disorders and therefore reducing their prevalence among this population.
* Contribution in the field of ED prevention, both at the research and practice level. To have an effective and validated tool for the Spanish population.
* Reduction of intervention costs. Prove the efficacy in preventive programs have an impact on a lower prevalence of EDs and therefore less need for intervention. Reducing not only economic costs, but also reducing the personal costs resulting from suffering an eating disorder.
* Improve mental health in the university population that has been identified as a vulnerable population with high prevalence of psychological problems.

Risks This program is preventive and does not pose a risk to the physical or mental health of the participants. Following the inclusion and exclusion criteria, if serious cases of ED are detected, they will be referred to a more specialized treatment adapted to their needs.

If during the development of the program any participant reports discomfort or some type of negative repercussion, they will immediately be removed from the program and the case will be studied for referral if necessary.

Where is the study run from?

Spain

When is the study starting and how long is it expected to run for?

The study began on 1st November 2022, it is expecting to last two years.

Who is funding the study?

This study is not funded by any organization

Who is the main contact? Dra. Carmen Varela carmenvarela@ub.edu cvarela@ubu.es

Eligibility criteria: Inclusion Criteria:

1. Female college students
2. Currently studying college degree, master or post-degree
3. Participants must show inform consent
4. Age \> 18 years

Exclusion Criteria:

1. Currently, absence of eating disorders or other several psychological problem
2. Currently on treatment for an eating disorder

Primary outcomes:
measure: Onset of Eating Disorders Symptomatology
timeFrame: 4 weeks
Secondary outcomes:
measure: State of Mood
timeFrame: 4 weeks
measure: Thin-ideal internalization
timeFrame: 4 weeks
measure: Body Dissatisfaction
timeFrame: 4 weeks
measure: Eating Behaviors
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Burgos
country: Spain
facility: Universidad de Burgos
Study officials:
References:
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