NCT05977582

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 4, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

October 20, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

5 months

First QC Date

July 19, 2023

Last Update Submit

February 19, 2024

Conditions

Keywords

PreventionCollege womenThin-ideal internalization

Outcome Measures

Primary Outcomes (1)

  • Onset of Eating Disorders Symptomatology

    Eating Attitudes Test -26 \[EAT-26\]

    4 weeks

Secondary Outcomes (4)

  • State of Mood

    4 weeks

  • Thin-ideal internalization

    4 weeks

  • Body Dissatisfaction

    4 weeks

  • Eating Behaviors

    4 weeks

Study Arms (2)

Spanish Version eBodyProject

EXPERIMENTAL

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.

Behavioral: Spanish version eBodyProject

Psychoeducational Prevention Program

ACTIVE COMPARATOR

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.

Behavioral: Psychoeducationa Prevention Program

Interventions

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.

Spanish Version eBodyProject

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.

Psychoeducational Prevention Program

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Burgos

Burgos, Spain

RECRUITING

Related Publications (13)

  • 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.

    PMID: 25020152BACKGROUND
  • 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.

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

    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.

    PMID: 21975593BACKGROUND
  • 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.

    PMID: 22506791BACKGROUND
  • 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.

    PMID: 33483119BACKGROUND
  • 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

    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.

    PMID: 24177441BACKGROUND
  • 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.

    PMID: 6961471BACKGROUND
  • 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.

    PMID: 20977051BACKGROUND
  • 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

    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.

    PMID: 25285718BACKGROUND
  • 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-

    BACKGROUND

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Central Study Contacts

Carmen Varela, PhD

CONTACT

Carmen Varela, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Researcher and Professor

Study Record Dates

First Submitted

July 19, 2023

First Posted

August 4, 2023

Study Start

October 20, 2023

Primary Completion

March 31, 2024

Study Completion

May 31, 2024

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

IDP will not be shared to other researchers to ensure the anonymity of the participants.

Locations