Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:28 PM
Study NCT ID:
NCT07466069
Status:
RECRUITING
Last Update Posted:
2026-03-12
First Post:
2026-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lifestyle Intervention for Obesity and Eating Disorder Prevention in Transgender Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': "Assessors of post-intervention body composition (DEXA) will be blinded to participants' group allocation."}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Experimental group and no intervention group (usual care group)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-06', 'studyFirstSubmitDate': '2026-03-02', 'studyFirstSubmitQcDate': '2026-03-06', 'lastUpdatePostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life (World Health Organization Quality of Life - BREF)', 'timeFrame': 'Baseline and 6 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Body fat', 'timeFrame': 'Baseline and 6 months', 'description': 'Body fat will be measured by dual-energy X-ray absorptiometry (DEXA).'}, {'measure': 'Muscle mass', 'timeFrame': 'Baseline and 6 months', 'description': 'Muscle mass will be measured by dual-energy X-ray absorptiometry (DEXA).'}, {'measure': 'Bone density', 'timeFrame': 'Baseline and 6 months', 'description': 'Bone density will be measured by dual-energy X-ray absorptiometry (DEXA).'}, {'measure': 'Body mass index (BMI)', 'timeFrame': 'Baseline and 6 months', 'description': '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.'}, {'measure': 'Food consumption', 'timeFrame': 'Baseline and 6 months', 'description': 'Food consumption will be assessed by three 24h food records.'}, {'measure': 'Food insecurity', 'timeFrame': 'Baseline and 6 months', 'description': '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.'}, {'measure': 'Diet quality (Diet Quality Scale - ESQUADA)', 'timeFrame': 'Baseline and 6 months', 'description': '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.'}, {'measure': 'Diet quality (Health Eating Index-2020)', 'timeFrame': 'Baseline and 6 months', 'description': '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.'}, {'measure': 'Food choice motives', 'timeFrame': 'Baseline and 6 months', 'description': '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.'}, {'measure': 'Screening for eating disorders', 'timeFrame': 'Baseline and 6 months', 'description': '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.'}, {'measure': 'Eating disorders symptoms', 'timeFrame': 'Baseline and 6 months', 'description': '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'}, {'measure': 'Body image dissatisfaction', 'timeFrame': 'Baseline and 6 months.', 'description': '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.'}, {'measure': 'Body image appreciation', 'timeFrame': 'Baseline and 6 months.', 'description': "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."}, {'measure': 'Physical activity level and sedentary behavior', 'timeFrame': 'Baseline and 6 months', 'description': '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.'}, {'measure': "Participant's perception of the intervention", 'timeFrame': '6 months', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transgender', 'Adolescent', 'Gender-diverse', 'Lifestyle', 'Eating disorders', 'Obesity'], 'conditions': ['Obesity & Overweight', 'Eating Disorders', 'Body Image Disturbance', 'Gender Diverse Populations']}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.\n\nThe 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.', 'detailedDescription': 'This study is a parallel-group randomized controlled trial conducted at the Lifestyle Medicine Center, Faculty of Medicine, University of São Paulo (FMUSP), Brazil.\n\nParticipants 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.\n\nAfter baseline assessments, participants will be randomly assigned (1:1), in blocks of six, to either:\n\n1. an interdisciplinary lifestyle intervention plus usual outpatient care; or\n2. usual outpatient care plus a single session of general health recommendations.\n\nThe 6-month intervention is grounded in Social Cognitive Theory and incorporates gender-affirmative principles and an intersectional framework. The intervention includes:\n\n* Monthly group sessions for adolescents\n* Monthly educational group sessions for caregivers\n* Weekly reinforcement messages\n\nThe 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.\n\nThe 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.\n\nOutcomes 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '10 Years', 'genderBased': True, 'genderDescription': 'Transgender and gender-diverse individuals.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 10-14 years\n* Self-identified as transgender or gender-diverse\n\nExclusion Criteria:\n\n* Current diagnosis of eating disorder requiring specialized treatment\n* Severe psychiatric instability\n* Cognitive impairment limiting participation'}, 'identificationModule': {'nctId': 'NCT07466069', 'briefTitle': 'Lifestyle Intervention for Obesity and Eating Disorder Prevention in Transgender Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Lifestyle Intervention to Prevent Obesity and Eating Disorders in Transgender and Gender-Diverse Adolescents: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'TRANSCEND study >10 years RCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TransForm Health group', 'description': 'A group intervention focused on promoting health lifestyle behaviors for preventing obesity and eating disorders in transgender and gender-diverse adolescents.', 'interventionNames': ['Behavioral: TransForm Health Program']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Usual care and general health lifestyle behaviors recommendations.'}], 'interventions': [{'name': 'TransForm Health Program', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['TransForm Health group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403010', 'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Bruno Gualano, PhD', 'role': 'CONTACT', 'email': 'gualano@usp.br', 'phone': '+551126618022'}], 'facility': 'Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Bruno Gualano, PhD', 'role': 'CONTACT', 'email': 'gualano@usp.br', 'phone': '+551130618789'}, {'name': 'Bruna Caruso Mazzolani, PhD', 'role': 'CONTACT', 'email': 'bruna.mazzolani@usp.br'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'timeFrame': 'After the analysis is completed', 'ipdSharing': 'YES', 'description': '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.', 'accessCriteria': 'Having been a participant in the RCT'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Bruno Gualano', 'investigatorAffiliation': 'University of Sao Paulo'}}}}