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Lifestyle Intervention to Prevent Obesity and Eating Disorders in Transgender and Gender-Diverse Adolescents: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Transgender and gender-diverse adolescents are at increased risk for obesity, disordered eating behaviors, body dissatisfaction, and reduced quality of life due to minority stress and structural inequities. However, no structured lifestyle interventions specifically tailored to this population have been developed. This randomized controlled trial aims to evaluate the effectiveness of a 6-month interdisciplinary lifestyle intervention designed to prevent obesity and eating disorders in transgender and gender-diverse adolescents aged 10-14 years. Participants will be randomized (1:1) to either an intervention group receiving monthly group sessions (for adolescents and caregivers separately) and weekly supportive messages, or a control group receiving standard outpatient care and general health recommendations. The primary outcome is quality of life measured by the WHOQOL-BREF. Secondary outcomes include eating disorder symptoms, body image, diet quality, physical activity levels, sedentary behavior, body composition, and anthropometric measures.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 14
Healthy Volunteers: f
View:

• Aged 10-14 years

• Self-identified as transgender or gender-diverse

Locations
Other Locations
Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
RECRUITING
São Paulo
Contact Information
Primary
Bruno Gualano, PhD
gualano@usp.br
+551130618789
Backup
Bruna Caruso Mazzolani, PhD
bruna.mazzolani@usp.br
Time Frame
Start Date: 2026-03
Estimated Completion Date: 2026-12
Participants
Target number of participants: 24
Treatments
Experimental: TransForm Health group
A group intervention focused on promoting health lifestyle behaviors for preventing obesity and eating disorders in transgender and gender-diverse adolescents.
No_intervention: Control group
Usual care and general health lifestyle behaviors recommendations.
Related Therapeutic Areas
Sponsors
Leads: University of Sao Paulo

This content was sourced from clinicaltrials.gov