Pilot Trial of the Body Image Program to Prevent Eating Disorders in Female University Students in Mexico

NCT07193043 | Not Yet Recruiting

• 1 other identifier: BIP-MX-Pilot-2025
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to examine whether the Body Image Program (BIP), a group workshop, is feasible and acceptable to deliver to young women in Mexico. The program is designed to help participants critically evaluate social pressures to be thin and to support healthier body attitudes. The main questions are:

• Can the investigators successfully recruit, retain, and engage university students in the program?
• Do participants find the program useful and clear?
• Does the program show early indications of lowering body dissatisfaction and unhealthy eating attitudes? Participants will:
• Attend 2 group sessions, one per week, each lasting approximately 2 hours (120 minutes).
• Complete short activities and homework exercises between sessions, such as reflective writing or self-affirmation tasks.
• Complete questionnaires at baseline, immediately after the program, and at 1-month follow-up.

Conditions

Eating Disorders; Body Dissatisfaction

Keywords

Eating Disorders Prevention; Body Image Program (BIP); Body Dissatisfaction; Dissonance-Based Intervention; Pilot Randomized Controlled Trial; University Students

Outcome Measures

Primary Outcomes (1)

• Eating Disorder Symptoms (ED-15 Total Score)

  Change in eating disorder symptoms measured by the Eating Disorder-15 (ED-15; Eating Disorder-15 Questionnaire), a 15-item self-report instrument that assesses core eating disorder symptoms over the past week. Items are rated on a 0-6 Likert scale. Scores yield two subscales (Eating Concerns; Weight/Shape Over-evaluation) and a total score calculated as the mean of all items. Possible scores range from 0 to 6, with higher scores indicating greater eating disorder symptom severity.

  Baseline (Week 0), Post-Intervention (Week 2), and 4-Week Follow-Up (Week 6)

Secondary Outcomes (4)

• Body Dissatisfaction (BSQ-8)

  Baseline (Week 0), Post-Intervention (Week 2), and 4-Week Follow-Up (Week 6)

• Body Appreciation (BAS-2)

  Baseline (Week 0), Post-Intervention (Week 2), and 4-Week Follow-Up (Week 6)

• Social Physique Anxiety (SPAS)

  Baseline (Week 0), Post-Intervention (Week 2), and 4-Week Follow-Up (Week 6)

• Internalization of Sociocultural Ideals (SATAQ-4)

  Baseline (Week 0), Post-Intervention (Week 2), and 4-Week Follow-Up (Week 6)

Other Outcomes (4)

• Recruitment Rate

  During the active recruitment period, up to first participant enrollment.

• Retention Rate

  T2 (week 2) and T3 (week 6)

• Session Adherence

  Across the 2-week intervention period.

Study Arms (2)

Body Image Program (BIP) Intervention

EXPERIMENTAL

Participants in this arm will receive the Body Image Program (BIP), a culturally adapted, dissonance-based group intervention derived from the Body Project. The program consists of two 120-minute sessions delivered in small groups of 7-10 participants, once per week for two consecutive weeks. Sessions include verbal, written, and behavioral exercises designed to reduce thin-ideal internalization, challenge sociocultural appearance pressures, and promote positive body image. Each session concludes with homework assignments, and a commitment task is submitted within one week after Session 2.

Behavioral: Body Image Program (BIP)

Waitlist Control

NO INTERVENTION

Participants in this arm will not receive the Body Image Program (BIP) during the main study period. They will complete the same assessments as the intervention group at baseline (T1), post-intervention (T2), and 4-week follow-up (T3). After the final follow-up assessment (week 6), they will be offered the opportunity to participate in the BIP between weeks 6 and 8, ensuring post-trial access in line with ethical standards.

Interventions

Body Image Program (BIP) BEHAVIORAL

The Body Image Program (BIP) is a culturally adapted, dissonance-based group intervention derived from the Body Project. It is delivered in two weekly sessions of 120 minutes each, in small groups of 7-10 participants, by trained health professionals with experience in eating disorders. Activities include verbal, written, and behavioral exercises to critique sociocultural appearance ideals, reduce thin-ideal internalization, and promote more adaptive body image. Each session ends with homework: after Session 1, tasks include a behavioral challenge and reflective writing; after Session 2, a commitment activity (e.g., self-affirmation or body activism) is completed within one week and submitted by email. Participants in the waitlist control arm complete the same assessments but receive the BIP between weeks 6 and 8, after the final follow-up.

Body Image Program (BIP) Intervention

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female undergraduate students
• Age 18-25 years
• Currently enrolled at participating universities in northeastern Mexico
• Able to provide written informed consent
• Sufficient Spanish language proficiency to complete the intervention and assessments

You may not qualify if:

• Current diagnosis of a severe eating disorder requiring specialized treatment
• Current engagement in intensive psychiatric or psychological treatment
• Insufficient availability to attend the two scheduled intervention sessions

Sponsors & Collaborators

• Comenzar de Nuevo, AC: lead

Study Sites (1)

Comenzar de Nuevo, A.C.

Monterrey, Nuevo León, 66220, Mexico

Location

Related Publications (10)

• van Hoeken D, Hoek HW. Review of the burden of eating disorders: mortality, disability, costs, quality of life, and family burden. Curr Opin Psychiatry. 2020 Nov;33(6):521-527. doi: 10.1097/YCO.0000000000000641.

  PMID: 32796186 BACKGROUND

• Cabassa LJ, Baumann AA. A two-way street: bridging implementation science and cultural adaptations of mental health treatments. Implement Sci. 2013 Aug 19;8:90. doi: 10.1186/1748-5908-8-90.

  PMID: 23958445 BACKGROUND

• Shaw H, Stice E. The implementation of evidence-based eating disorder prevention programs. Eat Disord. 2016;24(1):71-8. doi: 10.1080/10640266.2015.1113832. Epub 2015 Dec 9. No abstract available.

  PMID: 26650961 BACKGROUND

• Tavolacci MP, Grigioni S, Richard L, Meyrignac G, Dechelotte P, Ladner J. Eating Disorders and Associated Health Risks Among University Students. J Nutr Educ Behav. 2015 Sep-Oct;47(5):412-20.e1. doi: 10.1016/j.jneb.2015.06.009.

  PMID: 26363936 BACKGROUND

• Villalobos-Hernandez A, Bojorquez-Chapela I, Hernandez-Serrato MI, Unikel-Santoncini C. Prevalencia de conductas alimentarias de riesgo en adolescentes mexicanos: Ensanut Continua 2022. Salud Publica Mex. 2023 Jun 12;65:s96-s101. doi: 10.21149/14800. Spanish.

  PMID: 38060957 BACKGROUND

• Trujillo-ChiVacuan E, Winterman-Hemilson B, Compte EJ, Rodriguez G, Perez M, Black Becker C. Adaptation and implementation of body project as a universal body image program in Mexico and Latin America. Eat Disord. 2024 Nov-Dec;32(6):644-665. doi: 10.1080/10640266.2024.2360256. Epub 2024 Jun 3.

  PMID: 38828520 BACKGROUND

• Fairburn CG, Cooper Z, Shafran R. Cognitive behaviour therapy for eating disorders: a "transdiagnostic" theory and treatment. Behav Res Ther. 2003 May;41(5):509-28. doi: 10.1016/s0005-7967(02)00088-8.

  PMID: 12711261 BACKGROUND

• Stice E, Yokum S, Waters A. Dissonance-Based Eating Disorder Prevention Program Reduces Reward Region Response to Thin Models; How Actions Shape Valuation. PLoS One. 2015 Dec 7;10(12):e0144530. doi: 10.1371/journal.pone.0144530. eCollection 2015.

  PMID: 26641854 BACKGROUND

• Stice E, Rohde P, Gau J, Shaw H. An effectiveness trial of a dissonance-based eating disorder prevention program for high-risk adolescent girls. J Consult Clin Psychol. 2009 Oct;77(5):825-34. doi: 10.1037/a0016132.

  PMID: 19803563 BACKGROUND

• Trujillo-ChiVacuan EM, Winterman-Hemilson B, Trujillo-Valdes EY, Cortes-Morales A, Compte EJ. Culturally adapted body image program for Mexican university women: feasibility, acceptability, and cultural relevance in a Pilot RCT protocol. Front Psychiatry. 2026 Jan 14;16:1717786. doi: 10.3389/fpsyt.2025.1717786. eCollection 2025.

  PMID: 41614095 DERIVED

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Eva Trujillo-ChiVacuán, MD

  Comenzar de Nuevo, AC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilio J. Compte, PhD

CONTACT

+52811340.0275; emilio.compte@comenzardenuevo.net

Anid Cortés, MD

CONTACT

+52811340.0275; anid.cortes@comenzardenuevo.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm parallel assignment pilot randomized controlled trial, with participants allocated in a 1:1 ratio to the intervention (BIP) or waitlist control group.

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 25, 2025
• Study Start: November 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

ME (1)