Lifestyle Intervention for Obesity and Eating Disorder Prevention in Transgender Adolescents

Sponsor
University of Sao Paulo
Study ID
NCT07466069
Status
Recruiting
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Conditions

  • Body Image Disturbance
  • Eating Disorders
  • Gender Diverse Populations
  • Obesity & Overweight

Eligibility Criteria

Sex
ALL
Age
10 Years - 14 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Mar 12, 2026
Start date
Mar 31, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.

Primary Outcome Measure

Quality of Life (World Health Organization Quality of Life - BREF) [ Time Frame: Baseline and 6 months ]

Central Contacts

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