[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621722":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":43,"centralContacts":47,"locations":52,"responsibleParty":76,"collaborators":34,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":34,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":34,"enrollmentInfo":87,"targetDuration":34,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":99,"overallStatus":105,"whyStopped":34,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Washington University School of Medicine","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A: Educational Resources","ACTIVE_COMPARATOR","Participants will be provided direction to NIH educational resources over the course of the intervention. Both programs provide resources to improve nutrition, increase physical activity, limit screen time, and improve sleep and consist of online, free, assessable educational materials. Patients and caregivers will be reminded of this resource at their monthly clinic appointments for 6 months after their first study visit.",[13,14,15],"Behavioral: NIH Educational Resources","Behavioral: FitBit Ace","Behavioral: WashU Extended Learning Canvas",{"label":17,"type":18,"description":19,"interventionNames":20},"Arm B: Modified Guided Self-Help Family Intervention (mL-GSH)","EXPERIMENTAL","Participants will complete the Modified Guided Self-Help Family Intervention for survivors of leukemia (mL-GSH). ML-GSH is a six-session intervention to be delivered during appointments. Patients will have 6 months to complete the curriculum (may be up to 9 months to account for scheduling concerns).",[21,14,15],"Behavioral: Modified Guided Self-Help Family Intervention",[23,30,35,39],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"BEHAVIORAL","Modified Guided Self-Help Family Intervention","Patients and their caregivers will be led through mL-GSH in six sessions over the course of 6-9 months. Content is informed by priorities of caregivers and survivors of pediatric leukemia. The curriculum relies on participants identifying habits to monitor independently and supplementing their engagement with additional materials.",[17],[29],"mL-GSH",{"type":24,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"NIH Educational Resources","Patients and their caregivers will be provided education materials from the NIH. The educational resources are We Can! a National Institute of Health educational resource designed for parents, caregivers, and communities to help children ages 8 through 13 improve their health and Take Charge of Your Health which is designed to provide education to teenagers to improve their health",[9],null,{"type":24,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"FitBit Ace","Patients will be provided with a FitBit Ace. FitBit Ace will be worn by patients to track physical activity.",[9,17],{"type":24,"name":40,"description":41,"armGroupLabels":42,"otherNames":34},"WashU Extended Learning Canvas","All caregivers will be provided access to WashU Extended Learning Canvas. The WashU Extended Learning Canvas will have an online support group for caregivers to engage in with other caregivers in the trial.",[9,17],[44],{"name":45,"affiliation":5,"role":46},"Margaret Ferris, MD, PhD","PRINCIPAL_INVESTIGATOR",[48],{"name":45,"role":49,"phone":50,"phoneExt":34,"email":51},"CONTACT","314-454-6018","youngm@wustl.edu",[53],{"facility":5,"status":34,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"St Louis","Missouri","63110","United States","US",{"type":60,"coordinates":61},"Point",[62,63],-90.19789,38.62727,{"lat":63,"lon":62},[66,67,69,72,74],{"name":45,"role":49,"phone":50,"phoneExt":34,"email":51},{"name":68,"role":46,"phone":34,"phoneExt":34,"email":34},"Margaret Ferris, M.D., PhD",{"name":70,"role":71,"phone":34,"phoneExt":34,"email":34},"Mary Claire McGlynn, M.D.","SUB_INVESTIGATOR",{"name":73,"role":71,"phone":34,"phoneExt":34,"email":34},"Jessica Cooke, PhD",{"name":75,"role":71,"phone":34,"phoneExt":34,"email":34},"Feng Gao, PhD",{"type":77,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100621722","weight-gain-in-pediatric-leukemia-survivors-100621722",false,"NCT07374315","Weight Gain in Pediatric Leukemia Survivors","A Family-based Intervention Approach to Address Weight Gain in Pediatric Leukemia Survivors","Patient Eligibility Criteria:\n\n* Must have a diagnosis of ALL (T or B cell).\n* Must be receiving standard of care maintenance chemotherapy or be within 6 months of having concluded maintenance chemotherapy at the time of enrollment.\n* Must be at least 6 years of age and no older than 18 years of age at time of enrollment.\n* Must be able to speak and understand English.\n* Must have a caregiver who is participating in this study.\n* Must be able to perform some level of exercise (e.g., a brisk walk for at least five minutes) as determined by self-report.\n* Must not have severe developmental delay\u002Fintellectual disabilities (such as Trisomy32, severe presentations of autism spectrum disorder) or significant mental illness (such as active suicidal ideation, psychotic symptoms, manic or hypomanic episodes, or severe substance use disorder) that may interfere with ability to participate in modified Family Based Therapy (FBT).\n* Patients 10 and older must have a negative SCOFF screen for disordered eating (Score of 2 or more would disqualify the patient and require discussion with primary team)\n* Must be able to understand and willing to sign an IRB-approved written informed consent document or be able to provide verbal assent along with written consent provided by a legally authorized representative.\n\nCaregiver Eligibility Criteria:\n\n* Self-reported as the primary caregiver of a pediatric patient diagnosed with ALL who is also participating in this study.\n* Must be at least 18 years of age.\n* Must be able to speak and understand English.\n* Must be able to perform some level of exercise (e.g., a brisk walk for at least five minutes) as determined by self-report\n* Must be able to understand willing to sign an Institutional Review Board (IRB)-approved written informed consent document.","ALL","6 Years",{"count":88,"type":89},80,"ESTIMATED","INTERVENTIONAL",[92],"NA","This is a trial assessing the efficacy of two weight maintenance programs for children with acute lymphoblastic leukemia (ALL) and the patients' caregivers. Patients and their caregivers will be randomized 1:1 to Arm A, a non-intensive educational intervention using National Institute of Health (NIH) Educational Resources (We Can! for children 8-13 and Take Charge of Your Health for teenagers 14-18), or Arm B, a Modified Guided Self-Help Family Intervention for Leukemia patients (mL-GSH). Outcomes will be assessed through activity trackers, obesity biometrics, and nutrition and physical activity assessments.",[95,96,97,98],"Leukemia","Pediatric Acute Lymphoblastic Leukemia","Pediatric Acute Lymphoblastic Leukemia in Remission","Pediatric Obesity",[95,100,101,102,103,104],"Lymphoblastic Leukemia","Weight Management","Late Effects","Health Behaviors","Healthy Habits","NOT_YET_RECRUITING","2026-04-23",{"date":108,"type":109},"2026-04-28","ACTUAL",{"date":111,"type":89},"2026-05-31",{"date":113,"type":89},"2029-02-28",{"name":5,"class":6},1]