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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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:

Первичные конечные точки

• Eating Disorder Symptoms (ED-15 Total Score) [Срок оценки: Baseline (Week 0), Post-Intervention (Week 2), and 4-Week Follow-Up (Week 6)]

Вторичные конечные точки (4)

• Body Dissatisfaction (BSQ-8) [Срок оценки: Baseline (Week 0), Post-Intervention (Week 2), and 4-Week Follow-Up (Week 6)]
• Body Appreciation (BAS-2) [Срок оценки: Baseline (Week 0), Post-Intervention (Week 2), and 4-Week Follow-Up (Week 6)]
• Social Physique Anxiety (SPAS) [Срок оценки: Baseline (Week 0), Post-Intervention (Week 2), and 4-Week Follow-Up (Week 6)]
• Internalization of Sociocultural Ideals (SATAQ-4) [Срок оценки: Baseline (Week 0), Post-Intervention (Week 2), and 4-Week Follow-Up (Week 6)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Мексика · 1 центр

• Comenzar de Nuevo, A.C. — Monterrey

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07193043 · BIP-MX-Pilot-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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