Pilot Trial of the Body Image Program to Prevent Eating Disorders in Female University Students in Mexico
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-25
SponsorComenzar de Nuevo, AC
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Female undergraduate students
Age 18-25 years
Currently enrolled at participating universities in northeastern Mexico
Able to provide written informed consent
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Body Image Program (BIP)
BehavioralThe 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Body Image Program (BIP) InterventionExperimental treatment 1 intervention
Group B: Waitlist ControlNo intervention 0 interventions
Trial outcomes
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.
Time frame
Baseline (Week 0), Post-Intervention (Week 2), and 4-Week Follow-Up (Week 6)Secondary outcomes
1
Body Dissatisfaction (BSQ-8)
Body Shape Questionnaire-8 item (self-report). Total score (8-48); higher scores indicate greater body dissatisfaction.
Time frame
Baseline (Week 0), Post-Intervention (Week 2), and 4-Week Follow-Up (Week 6)2
Body Appreciation (BAS-2)
ody Appreciation Scale-2 (self-report, 10 items). Scores range from 1 to 5; higher scores indicate greater body appreciation.
Time frame
Baseline (Week 0), Post-Intervention (Week 2), and 4-Week Follow-Up (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.
Time frame
Baseline (Week 0), Post-Intervention (Week 2), and 4-Week Follow-Up (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.
Time frame
Baseline (Week 0), Post-Intervention (Week 2), and 4-Week Follow-Up (Week 6)Other outcomes
1
Recruitment Rate
Proportion of eligible students who consent and are randomized (feasibility indicator; target ≥70%)
Time frame
During the active recruitment period, up to first participant enrollment.2
Retention Rate
Proportion of randomized participants who complete T2 and T3 assessments (feasibility indicator; target ≥80%)
Time frame
T2 (week 2) and T3 (week 6)3
Session Adherence
Attendance categorized per participant as full (2/2 sessions), partial (1/2), or none (0/2); target ≥70% full adherence.
Time frame
Across the 2-week intervention period.4
Acceptability (Participant Satisfaction)
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.
Time frame
T2 (post-intervention, week 2)Sponsors and contacts
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Source ClinicalTrials.gov
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