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Recruiting NCT07466069

Lifestyle Intervention for Obesity and Eating Disorder Prevention in Transgender Adolescents

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Trial Parameters

Condition Obesity & Overweight
Sponsor University of Sao Paulo
Study Type INTERVENTIONAL
Phase N/A
Enrollment 24
Sex ALL
Min Age 10 Years
Max Age 14 Years
Start Date 2026-03
Completion 2026-12
Interventions
TransForm Health Program

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Brief 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 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

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