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Active, not recruiting

NCT Number: NCT07193043

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

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).

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Eating Disorders Body Dissatisfaction Feeding and Eating Disorders Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Comenzar de Nuevo, A.C.

Monterrey, Nuevo León, 66220, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

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

Primary outcomes

  1. Eating Disorder Symptoms (ED-15 Total Score)

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

    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.

Secondary outcomes

  1. Body Dissatisfaction (BSQ-8)

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

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

  2. Body Appreciation (BAS-2)

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

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

  3. Social Physique Anxiety (SPAS)

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

    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.

  4. Internalization of Sociocultural Ideals (SATAQ-4)

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

    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.

Other outcomes

  1. Recruitment Rate

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

    Proportion of eligible students who consent and are randomized (feasibility indicator; target ≥70%)

  2. Retention Rate

    Time frame: T2 (week 2) and T3 (week 6)

    Proportion of randomized participants who complete T2 and T3 assessments (feasibility indicator; target ≥80%)

  3. Session Adherence

    Time frame: Across the 2-week intervention period.

    Attendance categorized per participant as full (2/2 sessions), partial (1/2), or none (0/2); target ≥70% full adherence.

  4. Acceptability (Participant Satisfaction)

    Time frame: After completion of the BIP: at T2 for the intervention group and after completion of the delayed BIP for the waitlist control group.

    Brief ad hoc survey developed for this study. Three single-item questions assess perceived usefulness, clarity, and relevance of the program. Each item will be summarized descriptively as mean ratings and percentage of favorable responses. No standardized scale is used.

Sponsors and collaborators

Lead sponsor

Comenzar de Nuevo, AC

Other

Registry information

Official study title

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

Acronym: Pilot-BIP-MX

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 25, 2025
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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