Lifestyle Intervention for Obesity and Eating Disorder Prevention in Transgender Adolescents
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: TransForm Health Program.
- Кому может быть актуально
- Состояния в реестре: Obesity & Overweight, Eating Disorders, Body Image Disturbance, Gender Diverse Populations. Базовые параметры: 10 лет — 14 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Бразилия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Lifestyle Intervention to Prevent Obesity and Eating Disorders in Transgender and Gender-Diverse Adolescents: A Randomized Controlled Trial
Обзор
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.
Подробное описание
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.
Вмешательства
- Поведенческое 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.
Первичные конечные точки
- Quality of Life (World Health Organization Quality of Life - BREF) [Срок оценки: Baseline and 6 months]
Вторичные конечные точки (12)
- Body fat [Срок оценки: Baseline and 6 months]
- Muscle mass [Срок оценки: Baseline and 6 months]
- Bone density [Срок оценки: Baseline and 6 months]
- Body mass index (BMI) [Срок оценки: Baseline and 6 months]
- Food consumption [Срок оценки: Baseline and 6 months]
- Food insecurity [Срок оценки: Baseline and 6 months]
- Diet quality (Diet Quality Scale - ESQUADA) [Срок оценки: Baseline and 6 months]
- Diet quality (Health Eating Index-2020) [Срок оценки: Baseline and 6 months]
- Food choice motives [Срок оценки: Baseline and 6 months]
- Screening for eating disorders [Срок оценки: Baseline and 6 months]
- Eating disorders symptoms [Срок оценки: Baseline and 6 months]
- Body image dissatisfaction [Срок оценки: Baseline and 6 months.]
Критерии участия
Критерии включения
- Aged 10-14 years
- Self-identified as transgender or gender-diverse
Критерии исключения
- Current diagnosis of eating disorder requiring specialized treatment
- Severe psychiatric instability
- Cognitive impairment limiting participation
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Профилактика
Центры проведения
Бразилия · 1 центр
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo — São Paulo
Идентификаторы
NCT: NCT07466069 · TRANSCEND study >10 years RCT