Lifestyle program to prevent obesity and eating disorders in transgender and gender-diverse adolescents
Official title: Lifestyle Intervention to Prevent Obesity and Eating Disorders in Transgender and Gender-Diverse Adolescents: A Randomized Controlled Trial
Run by University of Sao Paulo · NCT07466069 · Data updated 2026-11-12
This project will test whether a 6-month gender-affirming lifestyle program with monthly group sessions for adolescents and caregivers plus weekly support messages helps transgender and gender-diverse 10–14-year-olds prevent obesity and eating disorders and improve quality of life.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 10 Years to 14 Years |
| Sex | All |
| Enrollment | 24 (estimated) |
| Sponsor | University of Sao Paulo Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Status | Recruiting |
| Started | March 2026 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | March 12, 2026 |
| Trial ID | NCT07466069 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are transgender or gender-diverse adolescents aged 10–14 who receive care at the AMTIGOS clinic and do not have an eating disorder requiring specialized treatment or severe psychiatric instability.
✕Probably not a fit
Patients with an active eating disorder that needs specialized treatment, severe psychiatric instability, significant cognitive impairment, those outside the 10–14 age range, or those not receiving care at AMTIGOS are unlikely to benefit from this program.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized parallel-group trial at the University of São Paulo enrolls transgender and gender-diverse adolescents aged 10–14 receiving care at the AMTIGOS clinic. Participants are randomized 1:1 to a 6-month interdisciplinary lifestyle intervention (monthly adolescent group sessions, monthly caregiver sessions, and weekly reinforcement messages) plus usual care or to usual care plus a single general-health session. The intervention is grounded in Social Cognitive Theory and uses gender-affirming and intersectional principles to promote healthy eating, increase physical activity, reduce sedentary behavior, support positive body image, and prevent unhealthy weight-control practices. The primary outcome is quality of life (WHOQOL-BREF) with secondary outcomes including eating-disorder symptoms, body image, diet quality, and physical activity.
Why it matters
Potential benefit: If successful, the program could improve quality of life and reduce risk factors for obesity and disordered eating among transgender adolescents by providing tailored, gender-affirming lifestyle support.
How similar studies have gone: Structured, tailored lifestyle interventions for transgender adolescents are largely novel, although general lifestyle programs for adolescents have shown benefits for diet, activity, and body image in non–gender-diverse populations.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 10-14 years * Self-identified as transgender or gender-diverse Exclusion Criteria: * Current diagnosis of eating disorder requiring specialized treatment * Severe psychiatric instability * Cognitive impairment limiting participation
Where it's running
-
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil Recruiting
Study contacts
- Study coordinator: Bruno Gualano, PhD
- Email: gualano@usp.br
- Phone: +551130618789
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.