Lifestyle Intervention to Prevent Obesity and Eating Disorders in Transgender and Gender-Diverse Adolescents: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Quality of Life (World Health Organization Quality of Life - BREF)
研究概览
简要总结
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.
详细描述
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:
- an interdisciplinary lifestyle intervention plus usual outpatient care; or
- 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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessors of post-intervention body composition (DEXA) will be blinded to participants' group allocation.
入排标准
- 年龄范围
- 10 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 10-14 years
- •Self-identified as transgender or gender-diverse
排除标准
- •Current diagnosis of eating disorder requiring specialized treatment
- •Severe psychiatric instability
- •Cognitive impairment limiting participation
研究组 & 干预措施
TransForm Health group
A group intervention focused on promoting health lifestyle behaviors for preventing obesity and eating disorders in transgender and gender-diverse adolescents.
干预措施: TransForm Health Program (Behavioral)
Control group
Usual care and general health lifestyle behaviors recommendations.
结局指标
主要结局
Quality of Life (World Health Organization Quality of Life - BREF)
时间窗: 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.
次要结局
- Body fat(Baseline and 6 months)
- Muscle mass(Baseline and 6 months)
- Bone density(Baseline and 6 months)
- Body mass index (BMI)(Baseline and 6 months)
- Food consumption(Baseline and 6 months)
- Food insecurity(Baseline and 6 months)
- Diet quality (Diet Quality Scale - ESQUADA)(Baseline and 6 months)
- Diet quality (Health Eating Index-2020)(Baseline and 6 months)
- Food choice motives(Baseline and 6 months)
- Screening for eating disorders(Baseline and 6 months)
- Eating disorders symptoms(Baseline and 6 months)
- Body image dissatisfaction(Baseline and 6 months.)
- Body image appreciation(Baseline and 6 months.)
- Physical activity level and sedentary behavior(Baseline and 6 months)
- Participant's perception of the intervention(6 months)
研究者
Bruno Gualano
Professor
University of Sao Paulo