[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04997473":3,"trial-entities:NCT04997473":87,"trial-summary:NCT04997473":91},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":13,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":34,"secondary_outcomes":39,"sex":43,"minimum_age":44,"maximum_age":45,"healthy_volunteers":46,"eligibility_criteria":47,"std_ages":59,"locations":62,"central_contacts":78,"overall_officials":80,"references":85,"see_also_links":86},"NCT04997473","UCLA BWL001","Behavioral Weight Loss Intervention Utilizing Mobile Health Technology in Hematopoietic Stem Cell Transplant Patients","RECRUITING","2027-01-09","2026-01","2026-01-28","2021-08-15","University of California, Los Angeles","OTHER",false,"Pilot study enrolling obese post HSCT (hematopoietic stem cell transplantation) patients at the hematology\u002Foncology clinic at the Mattel Children's Hospital, University of California, Los Angeles. Parameters include percent over the 95th percentile (%BMIp95), zBMI, fasting metabolic metrics, addictive eating habits, and motivation for change.","This is a pilot study enrolling obese patients, age 13-30, in an addiction model based smartphone mobile health (mHealth) weight loss intervention with coaching at a minimum of 100 days after hematopoietic stem cell transplantation. Patients will be screened and enrolled by the study coordinator, who will collect\u002Fsubmit biospecimens in addition to patient demographic characteristics and clinical outcomes. At the initial visit and enrollment, equipment will be disbursed to patients along with a schedule that outlines the 4-month intervention plan. After the initial visit, participants will participate in two additional in-clinic visits at 2 months and at the conclusion of the study at 4 months. Participants will also be involved in weekly phone calls and daily weekday texts to discuss their status for the 4 month duration.\n\nThis study will then correlate the results in change of BMI with patient characteristics, adherence to intervention, changes in metabolic parameters, physical activity levels, and addictive eating behaviors. Investigators are aiming to recruit a total of 20 adolescents\u002Fyoung adults total. No pilot group is necessary since the feasibility of this intervention has been validated in prior published studies.\n\nThe proposed model of delivery makes it possible to: 1) intervene with the participant and provide autonomy, 2) deliver the material over an extended period of time in a more convenient platform for the participant and families, 3) reduce many access barriers common in conventional outpatient obesity interventions, such as transportation or missed days of school and work, and 4) help youth develop skills to overcome their addictive eating behaviors.",[18,19],"Obesity","Stem Cell Transplant",[],"INTERVENTIONAL",[23],"NA",{"count":25,"type":26},20,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"BEHAVIORAL","W8L2G mobile health (mHealth) app","Weight loss phone app based on addiction principles. This intervention has been validated in two prior studies. Participants will also interact with coaches throughout the intervention",[33],"App Group",[35],{"measure":36,"description":37,"timeFrame":38},"BMI","To evaluate the effectiveness of an addiction-based weight loss intervention, embodied as a smartphone app with telephone coaching, on weight (weight and height will be combined to report BMI in kg\u002Fm\\^2) outcomes of overweight and obese post HSCT adolescents and young adults.","4 months",[40],{"measure":41,"description":42,"timeFrame":38},"Behavioral changes, metabolic parameters, feasibility of app","To evaluate the changes in metabolic parameters and physical activity levels, in addition to modifications in addictive eating behaviors, motivation, and self-regulatory behaviors. To evaluate the feasibility, adherence, and satisfaction of this intervention.","ALL","13 Years","30 Years",true,{"inclusion":48,"exclusion":53,"raw_text":58},[49,50,51,52],"Patients ≥ 13 and ≤ 30 years old with a history of HSCT of any type, at least 100 days post-transplant at initial consultation of the study, will be eligible for the study.","Both male and female patients will be eligible.","Patients must classify as obese, represented as Body mass index \\[BMI\\] ≥85th percentile for age and gender.","Patients must also be able to read English since the app intervention is only available in English form.",[54,55,56,57],"Patients who are ≤ 13 or ≥ 30 years old are not eligible for the study.","Patients who are \\\u003C 100 days post-transplant at initial consultation will not be eligible for the study, but may become eligible if they are \\>100 days post-transplant at their next consultation that falls within the enrollment window.","Patients whose BMI does not fall under the obese category will be excluded.","No patients will be excluded for any specific underlying medical condition, but decisions will be made on a case by case basis if a patient's functioning is deemed to significantly interfere with intervention participation.","Inclusion Criteria:\n\n* Patients ≥ 13 and ≤ 30 years old with a history of HSCT of any type, at least 100 days post-transplant at initial consultation of the study, will be eligible for the study.\n* Both male and female patients will be eligible.\n* Patients must classify as obese, represented as Body mass index \\[BMI\\] ≥85th percentile for age and gender.\n* Patients must also be able to read English since the app intervention is only available in English form.\n\nExclusion Criteria:\n\n* Patients who are ≤ 13 or ≥ 30 years old are not eligible for the study.\n* Patients who are \\\u003C 100 days post-transplant at initial consultation will not be eligible for the study, but may become eligible if they are \\>100 days post-transplant at their next consultation that falls within the enrollment window.\n* Patients whose BMI does not fall under the obese category will be excluded.\n* No patients will be excluded for any specific underlying medical condition, but decisions will be made on a case by case basis if a patient's functioning is deemed to significantly interfere with intervention participation.",[60,61],"CHILD","ADULT",[63],{"facility":64,"status":7,"city":65,"state":66,"zip":67,"country":68,"contacts":69,"geoPoint":75},"UCLA Mattel Children's Hospital","Los Angeles","California","90095","United States",[70],{"name":71,"role":72,"phone":73,"email":74},"Belen Ramirez","CONTACT","3102670425","belenramirez@mednet.ucla.edu",{"lat":76,"lon":77},34.05223,-118.24368,[79],{"name":71,"role":72,"phone":73,"email":74},[81],{"name":82,"affiliation":83,"role":84},"Theodore B Moore, MD","UCLA Health","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":88,"biomarkers":90},[89,18],"Hematopoietic Cell Transplantation",[],{"nct_id":4,"found":46,"summary":92,"prompt_version":102},{"design":93,"status":94,"heading":95,"summary":96,"follow_up":97,"word_count":98,"commitments":99,"compensation":100,"drugs_mentioned":101},"This is a pilot study with 20 participants. It is an interventional study, meaning participants will receive the W8L2G mobile health app and coaching.","completed","Weight Loss Study for Young Stem Cell Transplant Patients","This study is testing a mobile health (mHealth) app called W8L2G to help young people (ages 13-30) who have had a stem cell transplant and are obese. The app uses ideas from addiction principles to help with weight loss, and you'll also work with coaches. The main goal is to see if the app helps reduce Body Mass Index (BMI) after 4 months. This is a small pilot study aiming to enroll 20 participants. You can join if you are between 13 and 30 years old, have had a stem cell transplant at least 100 days ago, and are classified as obese.","The primary endpoint is measured at 4 months, which is the conclusion of the study.",102,"You will have an initial visit, followed by two in-clinic visits at 2 and 4 months. You will also have weekly phone calls and daily weekday texts for 4 months.","Not stated in the trial record.",[],"v2"]