Obesity & OverweightNCT07466069
Lifestyle Intervention for Obesity and Eating Disorder Prevention in Transgender Adolescents
A study testing TransForm Health Program in people with Obesity & Overweight and Eating Disorders, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 14 years
- Conditions the study is for
- Obesity & Overweight, Eating Disorders, Body Image Disturbance
- What is being tested?
- TransForm Health Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 10-14 years
- Self-identified as transgender or gender-diverse
Who cannot join
- Current diagnosis of eating disorder requiring specialized treatment
- Severe psychiatric instability
- Cognitive impairment limiting participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bruna Caruso Mazzolani, PhD contact
Brazil1 site, 1 recruiting
- Recruiting
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, 05403010
Bruno Gualano, PhD, +551126618022, gualano@usp.br
About this study
Official title: Lifestyle Intervention to Prevent Obesity and Eating Disorders in Transgender and Gender-Diverse Adolescents: A Randomized Controlled 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.
Read the 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:
- 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:
- 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.
- Conditions
- Obesity & Overweight, Eating Disorders, Body Image Disturbance, Gender Diverse Populations
- Being tested
- TransForm Health Program
- Keywords
- Transgender, Adolescent, Gender-diverse, Lifestyle, Eating disorders, Obesity
- Medical subject headings
- Obesity, Overweight, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TransForm Health ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: TransForm Health Program |
| Control group | No intervention | Usual care and general health lifestyle behaviors recommendations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 months
Secondary outcomes (15)
Body fat
Body fat will be measured by dual-energy X-ray absorptiometry (DEXA).
Measured: Baseline and 6 months
Muscle mass
Muscle mass will be measured by dual-energy X-ray absorptiometry (DEXA).
Measured: Baseline and 6 months
Bone density
Bone density will be measured by dual-energy X-ray absorptiometry (DEXA).
Measured: Baseline and 6 months
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.
Measured: Baseline and 6 months
Food consumption
Food consumption will be assessed by three 24h food records.
Measured: Baseline and 6 months
Food insecurity
Food insecurity will be assessed using the Brazilian Food Insecurity Scale (EBIA), a 14-item questionnaire assessing household access to food in the previous 90 days. The total score ranges from 0 to 14, with higher scores indicating greater food insecurity.
Measured: Baseline and 6 months
Diet quality (Diet Quality Scale - ESQUADA)
Diet quality will be assessed using the Diet Quality Scale (ESQUADA - Escala de Qualidade da Dieta), a questionnaire based on the Brazilian Dietary Guidelines. The total score ranges from 0 to 100, with higher scores indicating better diet quality.
Measured: Baseline and 6 months
Diet quality (Health Eating Index-2020)
Diet quality will also be assessed using the Healthy Eating Index-2020 (HEI-2020), a measure of adherence to the Dietary Guidelines for Americans. The total score ranges from 0 to 100, with higher scores indicating better diet quality.
Measured: Baseline and 6 months
Food choice motives
Determinants of food choice will be assessed using the Eating Motivation Survey - Brief Version (TEMS), a questionnaire assessing motivations underlying food choices across multiple domains. Items are rated on a 5-point Likert scale ranging from 1 to 5, with higher scores indicating stronger endorsement of the respective eating motivation.
Measured: Baseline and 6 months
Screening for eating disorders
Screening for eating disorders will be conducted using the SCOFF questionnaire, a 5-item screening tool with yes/no responses. Scores range from 0 to 5, with higher scores indicating greater likelihood of an eating disorder. A score of 2 or more positive responses suggests a possible eating disorder and indicates the need for further assessment.
Measured: Baseline and 6 months
Eating disorders symptoms
Eating disorder symptoms will be assessed using the Eating Disorder Examination Questionnaire (EDE-Q), a 28-item self-report instrument assessing eating disorder psychopathology over the previous 28 days. Items are rated on a 7-point scale ranging from 0 to 6, with higher scores indicating greater eating disorder psychopathology. The global score ranges from 0 to 6, representing the mean of four subscale scores
Measured: Baseline and 6 months
Body image dissatisfaction
Body dissatisfaction will be assessed using the Body Shape Questionnaire (BSQ), a 34-item questionnaire measuring concerns about body shape. Items are rated on a 6-point Likert scale, with total scores ranging from 34 to 204, where higher scores indicate greater body dissatisfaction.
Measured: Baseline and 6 months.
Body image appreciation
Body image apprciation will be assessed using the Body Appreciation Scale-2 (BAS-2), a 10-item questionnaire evaluating body appreciation and respect for one's body. Items are rated on a 5-point Likert scale, with total scores ranging from 10 to 50, where higher scores indicate greater body appreciation.
Measured: Baseline and 6 months.
Physical activity level and sedentary behavior
Physical activity and sedentary behavior will be assessed using the Physical Activity Questionnaire from the 2015 follow-up of the 1993 Pelotas Birth Cohort, which includes questions on leisure-time physical activity, active transportation, screen time, and sedentary behavior. Outcomes will be reported as time spent in physical activity and sedentary behaviors (minutes per week or hours per day), with higher physical activity indicating healthier behavior and higher sedentary time indicating less favorable behavior.
Measured: Baseline and 6 months
Participant's perception of the intervention
Participants' perceptions of the intervention will be assessed through post-intervention semi-structured focus groups. Audio-recorded discussions will be transcribed and analyzed using thematic qualitative analysis to identify key themes related to participants' experiences, perceived benefits, and challenges of the intervention.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental group and no intervention group (usual care group)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Gualano, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466069
- Sponsor's protocol ID
- TRANSCEND study >10 years RCT
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results produced will be shared as requested by participants. All those who wish to be included will be included in a specific category in publications where this is possible.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Intervention to Prevent Obesity and Eating Disorders in Transgender and Gender-Diverse Adolescents: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07466069
- Acronym / sponsor ID
- TRANSCEND study >10 years RCT
- Conditions
- Obesity & Overweight, Eating Disorders, Body Image Disturbance, Gender Diverse Populations
- Keywords
- Transgender, Adolescent, Gender-diverse, Lifestyle, Eating disorders, Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental group and no intervention group (usual care group)
| Arm | Type | Receives |
|---|---|---|
| TransForm Health group | Experimental | Behavioral: TransForm Health ProgramA group intervention focused on promoting health lifestyle behaviors for preventing obesity and eating disorders in transgender and gender-diverse adolescents. |
| Control group | No intervention | –Usual care and general health lifestyle behaviors recommendations. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Aged 10-14 years
- Self-identified as transgender or gender-diverse
Key exclusion criteria (3 listed)
- Current diagnosis of eating disorder requiring specialized treatment
- Severe psychiatric instability
- Cognitive impairment limiting participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TransForm Health ProgramA 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. | Behavioural | TransForm Health group |
Primary outcome
Quality of Life (World Health Organization Quality of Life - BREF)
Time frame: 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.
15 secondary outcomes
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.
Body image appreciation
Time frame: Baseline and 6 months.
Physical activity level and sedentary behavior
Time frame: Baseline and 6 months
Participant's perception of the intervention
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: Yes. The results produced will be shared as requested by participants. All those who wish to be included will be included in a specific category in publications where this is possible.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bruna Caruso Mazzolani, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TransForm Health Program in people with Obesity & Overweight and Eating Disorders, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bruno Gualano, PhD (+551130618789, gualano@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (World Health Organization Quality of Life - BREF) (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.