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

NCT ID: NCT07193043

Last Updated: 2025-09-25

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-01

Study Completion Date

2026-01-01

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 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.

Detailed Description

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

This study is a pilot randomized controlled trial designed to test the Body Image Program (BIP) with female university students in northeastern Mexico. Eating disorders and body dissatisfaction are common among young women and often begin during the university years. Most prevention programs have been evaluated only in Western countries. This study will evaluate whether the BIP, adapted for Mexico, is practical and acceptable to deliver in this setting.

The Body Image Program is a dissonance-based group intervention that encourages participants to challenge cultural pressures for thinness and to build healthier body image attitudes. In this study, participants in the intervention group will attend two sessions, each 120 minutes in duration, held once per week. Each session will include group discussions and exercises, and participants will complete short homework assignments between sessions. Sessions will be led by trained health professionals with experience in eating disorders.

A total of 30 students will be recruited and randomly assigned to either the intervention group or a waitlist control group. The intervention group will be divided into small groups of about 7-8 participants to maintain interactive discussions. Students in the waitlist control group will be offered the program after the final follow-up assessment.

The main outcomes of this study are feasibility and acceptability, including the number of eligible students who consent to participate, the proportion who complete both sessions and assessments, and whether participants find the program useful and relevant. Questionnaires will also assess body dissatisfaction, eating disorder symptoms, body appreciation, social physique anxiety, thin-ideal internalization, and appearance-based social comparisons. Assessments will take place at baseline, immediately after the program, and at 1-month follow-up.

This pilot study will provide information about whether the Body Image Program can be delivered effectively in Mexican universities and will inform the design of a larger clinical trial in the future.

Conditions

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

Eating Disorders Body Dissatisfaction

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

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

PREVENTION

Blinding Strategy

NONE

Study Groups

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

Body Image Program (BIP) Intervention

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.

Group Type EXPERIMENTAL

Body Image Program (BIP)

Intervention Type 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.

Waitlist Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Body Image Program (BIP)

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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

Comenzar de Nuevo, AC

OTHER

Sponsor Role lead

Responsible Party

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

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Eva Trujillo-ChiVacuán, MD

Role: PRINCIPAL_INVESTIGATOR

Comenzar de Nuevo, AC

Locations

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

Comenzar de Nuevo, A.C.

Monterrey, Nuevo León, Mexico

Site Status

Countries

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

Mexico

Central Contacts

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

Emilio J. Compte, PhD

Role: CONTACT

+52811340.0275

Anid Cortés, MD

Role: CONTACT

+52811340.0275

Facility Contacts

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

Emilio J. Compte, PhD

Role: primary

+52(81)1340.0275

Eva Trujillo-ChiVacuán, MD

Role: backup

+52(81)1340.0275

References

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

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.

Reference Type BACKGROUND
PMID: 32796186 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23958445 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26650961 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26363936 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38060957 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38828520 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12711261 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26641854 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19803563 (View on PubMed)

Other Identifiers

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

BIP-MX-Pilot-2025

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

The BEET Diabetes Feasibility Trial
NCT06247514 ENROLLING_BY_INVITATION NA