Lifestyle Intervention for Obesity and Eating Disorder Prevention in Transgender Adolescents
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TransForm Health Program.
- Who it may be relevant to
- Registry conditions: Obesity & Overweight, Eating Disorders, Body Image Disturbance, Gender Diverse Populations. Basic parameters: 10 years — 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Lifestyle Intervention to Prevent Obesity and Eating Disorders in Transgender and Gender-Diverse Adolescents: A Randomized Controlled Trial
Overview
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.
Detailed description
This study is a parallel-group randomized controlled trial conducted at the Lifestyle Medicine Center, Faculty of Medicine, University of São Paulo (FMUSP), Brazil.
Participants will be recruited from the Gender Identity and Sexual Orientation Outpatient Clinic (AMTIGOS) at the Institute of Psychiatry, Hospital das Clínicas, University of São Paulo. Eligible transgender and gender-diverse adolescents aged 10 to 14 years receiving care at AMTIGOS will be invited to participate.
After baseline assessments, participants will be randomly assigned (1:1), in blocks of six, to either:
1. an interdisciplinary lifestyle intervention plus usual outpatient care; or 2. usual outpatient care plus a single session of general health recommendations.
The 6-month intervention is grounded in Social Cognitive Theory and incorporates gender-affirmative principles and an intersectional framework. The intervention includes:
* Monthly group sessions for adolescents * Monthly educational group sessions for caregivers * Weekly reinforcement messages
The program focuses on promoting healthy eating behaviors, increasing physical activity, reducing sedentary behavior, preventing unhealthy weight-control practices, and fostering positive body image and body appreciation.
The control group will receive standard outpatient follow-up at AMTIGOS and a single individual session including general recommendations regarding healthy eating, physical activity, body acceptance, and avoidance of unhealthy weight-control behaviors.
Outcomes will be assessed at baseline and after 6 months. The primary outcome is quality of life measured by the WHOQOL-BREF. Secondary outcomes include eating disorder symptoms, body image, dietary quality, physical activity, sedentary behavior, body composition, and anthropometric measures.
Interventions
- Behavioral TransForm Health Program
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 outcome measures
- Quality of Life (World Health Organization Quality of Life - BREF) [Time frame: Baseline and 6 months]
Secondary outcome measures (12)
- Body fat [Time frame: Baseline and 6 months]
- Muscle mass [Time frame: Baseline and 6 months]
- Bone density [Time frame: Baseline and 6 months]
- Body mass index (BMI) [Time frame: Baseline and 6 months]
- Food consumption [Time frame: Baseline and 6 months]
- Food insecurity [Time frame: Baseline and 6 months]
- Diet quality (Diet Quality Scale - ESQUADA) [Time frame: Baseline and 6 months]
- Diet quality (Health Eating Index-2020) [Time frame: Baseline and 6 months]
- Food choice motives [Time frame: Baseline and 6 months]
- Screening for eating disorders [Time frame: Baseline and 6 months]
- Eating disorders symptoms [Time frame: Baseline and 6 months]
- Body image dissatisfaction [Time frame: Baseline and 6 months.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Brazil · 1 center
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo — São Paulo
Identifiers
NCT: NCT07466069 · TRANSCEND study >10 years RCT