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Eating DisordersPilot-BIP-MXNCT07193043

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

A study testing Body Image Program (BIP) in people with Eating Disorders and Body Dissatisfaction, run by Comenzar de Nuevo, AC at 1 site in Mexico.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 25 years, women onlyHealthy volunteers can take part
Conditions the study is for
Eating Disorders, Body Dissatisfaction
What is being tested?
Body Image Program (BIP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteMexico
Study dates
26 Aug 2026to 15 Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 25 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Female undergraduate students
  • Age 18-25 years
  • Currently enrolled as an undergraduate student at a university in northern Mexico
  • Able to provide written informed consent
  • Sufficient Spanish language proficiency to complete the intervention and assessments

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Mexico1 site
  • Comenzar de Nuevo, A.C.

    Monterrey, Nuevo León, 66220

Other trials in Mexico

About this study

Official title: A Pilot Randomized Controlled Trial of the Body Image Program (BIP) for Eating Disorder Prevention in Female University Students in Northern Mexico

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?
Read more

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 (T1), 2 weeks (T2), and 6 weeks (T3).
Read the detailed description

This study is a pilot randomized controlled trial designed to test the Body Image Program (BIP) with female university students in northern 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 feasible and acceptable to deliver among female university students in northern Mexico.

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 completing the T3 assessment at 6 weeks.

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, and thin-ideal internalization. Assessments will take place at baseline (T1, Week 0), 2 weeks (T2), and 6 weeks (T3).

This pilot study will provide information about whether the Body Image Program can be delivered effectively among female university students in northern Mexico and will inform the design of a larger clinical trial in the future.

Being tested
Body Image Program (BIP)
Keywords
Eating Disorders Prevention, Body Image Program (BIP), Body Dissatisfaction, Dissonance-Based Intervention, Pilot Randomized Controlled Trial, University Students
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.

  • Body Image Program (BIP)Behavioural

    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 and are offered the BIP after completing the T3 assessment at 6 weeks.

Study groups in NCT07193043
Study groupRoleWhat they receive
Body Image Program (BIP) InterventionExperimentalParticipants 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.
Receives: Behavioral: Body Image Program (BIP)
Waitlist ControlNo interventionParticipants in this arm will not receive the Body Image Program (BIP) during the initial study period. They will complete the same assessments as the intervention group at baseline (T1), 2 weeks (T2), and 6 weeks (T3). After completing the T3 assessment, they will be offered the opportunity to participate in the BIP.

What is being measured

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

  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.

    Measured: Baseline (T1, Week 0), T2 (Week 2), and T3 (Week 6)

Secondary outcomes (4)
  1. Body Dissatisfaction (BSQ-8)

    Body Shape Questionnaire-8 item (self-report). Total score (8-48); higher scores indicate greater body dissatisfaction.

    Measured: Baseline (T1, Week 0), T2 (Week 2), and T3 (Week 6)

  2. Body Appreciation (BAS-2)

    Body Appreciation Scale-2 (self-report, 10 items). Scores range from 1 to 5; higher scores indicate greater body appreciation.

    Measured: Baseline (T1, Week 0), T2 (Week 2), and T3 (Week 6)

  3. Social Physique Anxiety (SPAS)

    Social Physique Anxiety Scale-7 (self-report, 7 items). Scores range from 1 to 5; higher scores indicate greater anxiety about appearance in social settings.

    Measured: Baseline (T1, Week 0), T2 (Week 2), and T3 (Week 6)

  4. Internalization of Sociocultural Ideals (SATAQ-4)

    Internalization of Sociocultural Ideals (Thin-Ideal Internalization Subscale of the Sociocultural Attitudes Toward Appearance Questionnaire-4) Self-report, 5 items. Each item rated on a 1-5 Likert scale. Total score is calculated as the mean of all items, with possible values ranging from 1 to 5. Higher scores indicate stronger internalization of thinness ideals.

    Measured: Baseline (T1, Week 0), T2 (Week 2), and T3 (Week 6)

Timeline

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

  1. First posted25 Sep 2025
  2. Study start26 Aug 2026
  3. Primary completion8 Oct 2026 (estimated)
  4. Study completion15 Oct 2026 (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
Model description
Two-arm parallel assignment pilot randomized controlled trial, with participants allocated in a 1:1 ratio to the intervention (BIP) or waitlist control group.
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07193043
Sponsor's protocol ID
BIP-MX-Pilot-2025
Acronym
Pilot-BIP-MX
Status last verified
Aug 2026
First submitted
16 Sep 2025
Last updated
1 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data underlying the results reported in the primary publication will be shared. Direct personal identifiers will be removed prior to data sharing.

Publications

  • 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.

    PubMed 41614095
  • 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.

    PubMed 32796186
  • 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.

    PubMed 23958445
  • 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.

    PubMed 26650961
  • 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.

    PubMed 26363936
  • 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.

    PubMed 38060957
  • 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.

    PubMed 38828520
  • 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.

    PubMed 12711261
  • 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.

    PubMed 26641854
  • 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.

    PubMed 19803563

Questions about this trial

What is this clinical trial studying?

A study testing Body Image Program (BIP) in people with Eating Disorders and Body Dissatisfaction, run by Comenzar de Nuevo, AC at 1 site in Mexico.

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 5 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 1 Sep 2026. 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 Mexico. 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?

This study is still under way. Results are not available in the source record yet.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Eating Disorder Symptoms (ED-15 Total Score) (time frame: Baseline (T1, Week 0), T2 (Week 2), and T3 (Week 6)). 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 NCT07193043, which also lists 10 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 1 Sep 2026.

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