Clinical trial

Lifestyle Intervention for Obesity and Eating Disorder Prevention in Transgender Adolescents

Recruiting now · Not applicable · 1 countries · Registry ID NCT07466069

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age10 Years to 14 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity & Overweight, Eating Disorders, Body Image Disturbance, Gender Diverse Populations

Full registry 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

Treatments and study arms

TransForm Health Program

Behavioral

A 6-month structured intervention including monthly adolescent group sessions, monthly caregiver sessions, monthly individual goal-setting meetings, and weekly reinforcement messages focused on healthy eating, physical activity, body appreciation, and prevention of unhealthy weight-control behaviors.

Primary outcomes

Quality of Life (World Health Organization Quality of Life - BREF)Baseline and 6 months

Quality of life will be measured using the World Health Organization Quality of Life - BREF (WHOQOL-BREF) questionnaire. The WHOQOL-BREF consists of 26 items covering four domains (physical health, psychological health, social relationships, and environment). Domain scores are transformed to a scale ranging from 0 to 100, with higher scores indicating better quality of life.

Study locations

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Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo🇧🇷 São Paulo, São Paulo, Brazil

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Bruno Gualano, PhDContact

Email · Call +551126618022