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

Primary Purpose

Eating Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Spanish version eBodyProject
Psychoeducationa Prevention Program
Sponsored by
University of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Eating Disorders focused on measuring Prevention, College women, Thin-ideal internalization

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Female college students Currently studying college degree, master or post-degree Participants must show inform consent Age > 18 years Exclusion Criteria: Currently, absence of eating disorders or other several psychological problem Currently on treatment for an eating disorder

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Spanish Version eBodyProject

    Psychoeducational Prevention Program

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Onset of Eating Disorders Symptomatology
    Eating Attitudes Test -26 [EAT-26]

    Secondary Outcome Measures

    State of Mood
    Beck Depression Inventory [BDI]
    Thin-ideal internalization
    Sociocultural Attitudes Towards Appearance Questionnaire 4 [SATAQ-4]
    Body Dissatisfaction
    Body Shape Questionnaire [BSQ]
    Eating Behaviors
    The Dutch Eating Behavior Questionnaire [DEBQ]

    Full Information

    First Posted
    July 19, 2023
    Last Updated
    July 28, 2023
    Sponsor
    University of Barcelona
    Collaborators
    University of Burgos
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05977582
    Brief Title
    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

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 20, 2023 (Anticipated)
    Primary Completion Date
    March 31, 2024 (Anticipated)
    Study Completion Date
    May 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Barcelona
    Collaborators
    University of Burgos

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Eating Disorders
    Keywords
    Prevention, College women, Thin-ideal internalization

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Spanish Version eBodyProject
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Psychoeducational Prevention Program
    Arm Type
    Active Comparator
    Arm Description
    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
    Intervention Name(s)
    Spanish version eBodyProject
    Intervention Description
    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
    Intervention Name(s)
    Psychoeducationa Prevention Program
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Onset of Eating Disorders Symptomatology
    Description
    Eating Attitudes Test -26 [EAT-26]
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    State of Mood
    Description
    Beck Depression Inventory [BDI]
    Time Frame
    4 weeks
    Title
    Thin-ideal internalization
    Description
    Sociocultural Attitudes Towards Appearance Questionnaire 4 [SATAQ-4]
    Time Frame
    4 weeks
    Title
    Body Dissatisfaction
    Description
    Body Shape Questionnaire [BSQ]
    Time Frame
    4 weeks
    Title
    Eating Behaviors
    Description
    The Dutch Eating Behavior Questionnaire [DEBQ]
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Female college students Currently studying college degree, master or post-degree Participants must show inform consent Age > 18 years Exclusion Criteria: Currently, absence of eating disorders or other several psychological problem Currently on treatment for an eating disorder
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Carmen Varela, PhD
    Phone
    +34660732463
    Email
    carmenvarela@ub.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Carmen Varela, PhD
    Phone
    +34660732463
    Email
    cvarela@ubu.es

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    IDP will not be shared to other researchers to ensure the anonymity of the participants.
    Citations:
    PubMed Identifier
    25020152
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    34048952
    Citation
    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.
    Results Reference
    background
    Citation
    Stice, E., Rohde, P. & Shaw, H. (2013). The Body Project. Oxford.
    Results Reference
    background
    PubMed Identifier
    21975593
    Citation
    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.
    Results Reference
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    PubMed Identifier
    22506791
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    33483119
    Citation
    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.
    Results Reference
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    Citation
    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
    Results Reference
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    PubMed Identifier
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    Citation
    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.
    Results Reference
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    PubMed Identifier
    6961471
    Citation
    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.
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    PubMed Identifier
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    Citation
    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.
    Results Reference
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    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
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    Citation
    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.
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