Actively Recruiting
Lifestyle Intervention to Prevent Obesity and Eating Disorders in Transgender and Gender-Diverse Adolescents: A Randomized Controlled Trial
Led by University of Sao Paulo · Updated on 2026-03-12
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Transgender and gender-diverse adolescents face higher risks of obesity, disordered eating, body dissatisfaction, and lower quality of life due to social stress and inequalities. This randomized controlled trial is evaluating a 6-month interdisciplinary lifestyle program to prevent obesity and eating disorders in transgender and gender-diverse youth aged 10 to 14 years. The study measures quality of life as the main outcome, along with symptoms of eating disorders, body image, diet, activity levels, and body composition. Participants will be randomly assigned to either the TransForm Health Program or a control group. The TransForm Health Program includes monthly group sessions for adolescents and caregivers separately, individual goal-setting meetings, and weekly supportive messages focusing on healthy eating, physical activity, positive body image, and avoiding unhealthy weight control. The control group receives usual outpatient care plus one session with general health advice. Participants will be assessed at the start and end of the 6-month period using questionnaires, body measurements, and evaluations of diet and activity. Researchers will track changes in quality of life, eating disorder symptoms, physical health, and body image. The study will provide insight into how tailored lifestyle support may impact health and well-being in transgender and gender-diverse adolescents.
CONDITIONS
Brief Title
Lifestyle Intervention for Obesity and Eating Disorder Prevention in Transgender Adolescents
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 10-14 years
- Self-identified as transgender or gender-diverse
You will not qualify if you...
- Current diagnosis of eating disorder requiring specialized treatment
- Severe psychiatric instability
- Cognitive impairment limiting participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive a 6-month lifestyle intervention including monthly group sessions for adolescents and caregivers, monthly individual goal-setting meetings, and weekly reinforcement messages focused on healthy eating, physical activity, body appreciation, and prevention of unhealthy weight-control behaviors. The control group receives usual outpatient care plus a single session of general health recommendations.
Monthly group sessions for adolescents and caregivers, weekly reinforcement messages, and monthly individual meetings
Duration - 1 visit at 6 months post-baseline
Outcomes are assessed at the end of the 6-month intervention to evaluate quality of life, eating disorder symptoms, body image, dietary quality, physical activity, sedentary behavior, body composition, and anthropometric measures.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil, 05403010
Actively Recruiting
Research Team
B
Bruno Gualano, PhD
B
Bruna Caruso Mazzolani, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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