Lifestyle Intervention for Obesity and Eating Disorder Prevention in Transgender Adolescents
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-14
SponsorUniversity of Sao Paulo
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 10-14 years
Self-identified as transgender or gender-diverse
Disqualifiers
Current diagnosis of eating disorder requiring specialized treatment
Severe psychiatric instability
Cognitive impairment limiting participation
Trial design
Design model
Parallel
Treatments tested in this trial
TransForm Health Program
BehavioralA 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.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: TransForm Health groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Quality of Life (World Health Organization Quality of Life - BREF)
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.
Time frame
Baseline and 6 monthsSecondary outcomes
1
Body fat
Body fat will be measured by dual-energy X-ray absorptiometry (DEXA).
Time frame
Baseline and 6 months2
Muscle mass
Muscle mass will be measured by dual-energy X-ray absorptiometry (DEXA).
Time frame
Baseline and 6 months3
Bone density
Bone density will be measured by dual-energy X-ray absorptiometry (DEXA).
Time frame
Baseline and 6 months4
Body mass index (BMI)
BMI Z-score will be assessed by weight (kg) and height (m) that will be combined to report BMI in kg/m\^2 Z-score according to the World Health Organization growth curves.
Time frame
Baseline and 6 monthsSponsors and contacts
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Source ClinicalTrials.gov