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Eating DisordersNCT05977582

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

A study testing Spanish version eBodyProject and Psychoeducationa Prevention Program in people with Eating Disorders, run by University of Barcelona at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Eating Disorders
What is being tested?
Spanish version eBodyProject and Psychoeducationa Prevention Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSpain
Study dates
20 Oct 2023to 31 May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Female college students
  • Currently studying college degree, master or post-degree
  • Participants must show inform consent
  • Age > 18 years

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Carmen Varela, PhD contact

+34660732463

carmenvarela@ub.edu

Carmen Varela, PhD contact

+34660732463

cvarela@ubu.es

Spain1 site, 1 recruiting
  • Universidad de Burgos

    Burgos

    Carmen Varela, PHD

    Recruiting

Other trials in Spain

About this study

Official title: Prevention Program for Eating Disorders Applied to College Students Using a Virtual Platform. Spanish Validation of the eBodyProject

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).
Read more

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.

Read the 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

Being tested
Spanish version eBodyProject, Psychoeducationa Prevention Program
Keywords
Prevention, College women, Thin-ideal internalization
Medical subject headings
Feeding and Eating Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Spanish version eBodyProjectBehavioural

    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.

  • Psychoeducationa Prevention ProgramBehavioural

    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.

Study groups in NCT05977582
Study groupRoleWhat they receive
Spanish Version eBodyProjectExperimentalThe 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.
Receives: Behavioral: Spanish version eBodyProject
Psychoeducational Prevention ProgramActive comparatorParticipants 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.
Receives: Behavioral: Psychoeducationa Prevention Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Onset of Eating Disorders Symptomatology

    Eating Attitudes Test -26 [EAT-26]

    Measured: 4 weeks

Secondary outcomes (4)
  1. State of Mood

    Beck Depression Inventory [BDI]

    Measured: 4 weeks

  2. Thin-ideal internalization

    Sociocultural Attitudes Towards Appearance Questionnaire 4 [SATAQ-4]

    Measured: 4 weeks

  3. Body Dissatisfaction

    Body Shape Questionnaire [BSQ]

    Measured: 4 weeks

  4. Eating Behaviors

    The Dutch Eating Behavior Questionnaire [DEBQ]

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2023
  2. Study start20 Oct 2023
  3. Primary completion31 Mar 2024 (estimated)
  4. Study completion31 May 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05977582
Sponsor's protocol ID
IR15/2023
Status last verified
Feb 2024
First submitted
19 Jul 2023
Last updated
20 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IDP will not be shared to other researchers to ensure the anonymity of the participants.

Publications

  • 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.

    PubMed 25020152
  • 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.

    PubMed 34048952
  • Stice, E., Rohde, P. & Shaw, H. (2013). The Body Project. Oxford.

  • 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.

    PubMed 21975593
  • 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.

    PubMed 22506791
  • 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.

    PubMed 33483119
  • 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

  • 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.

    PubMed 24177441
  • 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.

    PubMed 6961471
  • 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.

    PubMed 20977051
  • 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

  • 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.

    PubMed 25285718
  • 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-

Questions about this trial

What is this clinical trial studying?

A study testing Spanish version eBodyProject and Psychoeducationa Prevention Program in people with Eating Disorders, run by University of Barcelona at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Carmen Varela, PhD (+34660732463, carmenvarela@ub.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Onset of Eating Disorders Symptomatology (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05977582, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.

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