Lifestyle Intervention for Obesity and Eating Disorder Prevention in Transgender Adolescents

NCT07466069 | Recruiting

• 1 other identifier: TRANSCEND study >10 years RCT
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity & Overweight; Eating Disorders; Body Image Disturbance; Gender Diverse Populations

Keywords

Transgender; Adolescent; Gender-diverse; Lifestyle; Eating disorders; Obesity

Outcome Measures

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.

  Baseline and 6 months

Secondary Outcomes (15)

• 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

Study Arms (2)

TransForm Health group

EXPERIMENTAL

A group intervention focused on promoting health lifestyle behaviors for preventing obesity and eating disorders in transgender and gender-diverse adolescents.

Behavioral: TransForm Health Program

Control group

NO INTERVENTION

Usual care and general health lifestyle behaviors recommendations.

Interventions

TransForm Health Program BEHAVIORAL

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.

TransForm Health group

Eligibility Criteria

• Age: 10 Years - 14 Years
• Gender Eligibility Details: Transgender and gender-diverse individuals.
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged 10-14 years
• Self-identified as transgender or gender-diverse

You may not qualify if:

• Current diagnosis of eating disorder requiring specialized treatment
• Severe psychiatric instability
• Cognitive impairment limiting participation

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, 05403010, Brazil

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Mental Disorders

Central Study Contacts

Bruno Gualano, PhD

CONTACT

+551130618789; gualano@usp.br

Bruna Caruso Mazzolani, PhD

CONTACT

bruna.mazzolani@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors of post-intervention body composition (DEXA) will be blinded to participants' group allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Experimental group and no intervention group (usual care group)

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 12, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: After the analysis is completed
• Access Criteria: Having been a participant in the RCT

Locations

BR (1)