Online Prevention Program for Eating Disorders Applied to College Students. Spanish Validation of the eBodyProject

NCT ID: NCT05977582

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-20

Study Completion Date

2024-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 [email protected] [email protected]

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Eating Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Spanish Version eBodyProject

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.

Group Type EXPERIMENTAL

Spanish version eBodyProject

Intervention Type BEHAVIORAL

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.

Psychoeducational Prevention Program

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.

Group Type ACTIVE_COMPARATOR

Psychoeducationa Prevention Program

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Spanish version eBodyProject

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.

Intervention Type BEHAVIORAL

Psychoeducationa Prevention Program

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Burgos

UNKNOWN

Sponsor Role collaborator

University of Barcelona

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Carmen Varela

PhD, Researcher and Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universidad de Burgos

Burgos, , Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Carmen Varela, PhD

Role: CONTACT

+34660732463

Carmen Varela, PhD

Role: CONTACT

+34660732463

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Carmen Varela, PHD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Stice E, Durant S, Rohde P, Shaw H. Effects of a prototype Internet dissonance-based eating disorder prevention program at 1- and 2-year follow-up. Health Psychol. 2014 Dec;33(12):1558-67. doi: 10.1037/hea0000090. Epub 2014 Jul 14.

Reference Type BACKGROUND
PMID: 25020152 (View on PubMed)

Stice E, Onipede ZA, Marti CN. A meta-analytic review of trials that tested whether eating disorder prevention programs prevent eating disorder onset. Clin Psychol Rev. 2021 Jul;87:102046. doi: 10.1016/j.cpr.2021.102046. Epub 2021 May 21.

Reference Type BACKGROUND
PMID: 34048952 (View on PubMed)

Stice, E., Rohde, P. & Shaw, H. (2013). The Body Project. Oxford.

Reference Type BACKGROUND

Stice E, Rohde P, Gau J, Shaw H. Effect of a dissonance-based prevention program on risk for eating disorder onset in the context of eating disorder risk factors. Prev Sci. 2012 Apr;13(2):129-39. doi: 10.1007/s11121-011-0251-4.

Reference Type BACKGROUND
PMID: 21975593 (View on PubMed)

Stice E, Rohde P, Durant S, Shaw H. A preliminary trial of a prototype Internet dissonance-based eating disorder prevention program for young women with body image concerns. J Consult Clin Psychol. 2012 Oct;80(5):907-16. doi: 10.1037/a0028016. Epub 2012 Apr 16.

Reference Type BACKGROUND
PMID: 22506791 (View on PubMed)

Luo YJ, Jackson T, Stice E, Chen H. Effectiveness of an Internet Dissonance-Based Eating Disorder Prevention Intervention Among Body-Dissatisfied Young Chinese Women. Behav Ther. 2021 Jan;52(1):221-233. doi: 10.1016/j.beth.2020.04.007. Epub 2020 Apr 19.

Reference Type BACKGROUND
PMID: 33483119 (View on PubMed)

Beck, A. T., Steer, R. A. y Brown, G. (1996). Beck Depression Inventory-II (BDI-II). APA PsycTests. https://doi.org/10.1037/t00742-000

Reference Type BACKGROUND

Cebolla A, Barrada JR, van Strien T, Oliver E, Banos R. Validation of the Dutch Eating Behavior Questionnaire (DEBQ) in a sample of Spanish women. Appetite. 2014 Feb;73:58-64. doi: 10.1016/j.appet.2013.10.014. Epub 2013 Oct 28.

Reference Type BACKGROUND
PMID: 24177441 (View on PubMed)

Garner DM, Olmsted MP, Bohr Y, Garfinkel PE. The eating attitudes test: psychometric features and clinical correlates. Psychol Med. 1982 Nov;12(4):871-8. doi: 10.1017/s0033291700049163.

Reference Type BACKGROUND
PMID: 6961471 (View on PubMed)

Rivas T, Bersabe R, Jimenez M, Berrocal C. The Eating Attitudes Test (EAT-26): reliability and validity in Spanish female samples. Span J Psychol. 2010 Nov;13(2):1044-56. doi: 10.1017/s1138741600002687.

Reference Type BACKGROUND
PMID: 20977051 (View on PubMed)

Sanz, J., Perdigón, A. L. y Vázquez, C. (2003). Adaptación española del Inventario para la Depresión de Beck-II (BDI-II): 2. Propiedades psicométricas en población general. Clínica y Salud, 14(3), 249-280. https://www.redalyc.org/pdf/1806/180617972001.pdf

Reference Type BACKGROUND

Schaefer LM, Burke NL, Thompson JK, Dedrick RF, Heinberg LJ, Calogero RM, Bardone-Cone AM, Higgins MK, Frederick DA, Kelly M, Anderson DA, Schaumberg K, Nerini A, Stefanile C, Dittmar H, Clark E, Adams Z, Macwana S, Klump KL, Vercellone AC, Paxton SJ, Swami V. Development and validation of the Sociocultural Attitudes Towards Appearance Questionnaire-4 (SATAQ-4). Psychol Assess. 2015 Mar;27(1):54-67. doi: 10.1037/a0037917. Epub 2014 Oct 6.

Reference Type BACKGROUND
PMID: 25285718 (View on PubMed)

Van Strien T., Frijters J., Bergers G. y Defares P. (1986). The Dutch Eating Behavior Questionnaire (DEBQ) for assessment of restrained, emotional and external eating behaviors. International Journal of Eating Behaviors. https://doi.org/10.1002/1098108X(198602)5:2<295::AID-EAT2260050209>3.0.CO;2-

Reference Type BACKGROUND

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IR15/2023

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Eating Disorders Among Adolescents
NCT05722470 NOT_YET_RECRUITING