Weight Gain in Pediatric Leukemia Survivors
A Family-based Intervention Approach to Address Weight Gain in Pediatric Leukemia Survivors
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 6 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
Patient Eligibility Criteria: * Must have a diagnosis of ALL (T or B cell). * Must be receiving standard of care maintenance chemotherapy or be within 6 months of having concluded maintenance chemotherapy at the time of enrollment. * Must be at least 6 years of age and no older than 18 years of age at time of enrollment. * Must be able to speak and understand English. * Must have a caregiver who is participating in this study. * Must be able to perform some level of exercise (e.g., a brisk walk for at least five minutes) as determined by self-report. * Must not have severe developmental delay/intellectual 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). * 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) * 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. Caregiver Eligibility Criteria: * Self-reported as the primary caregiver of a pediatric patient diagnosed with ALL who is also participating in this study. * Must be at least 18 years of age. * Must be able to speak and understand English. * Must be able to perform some level of exercise (e.g., a brisk walk for at least five minutes) as determined by self-report * Must be able to understand willing to sign an Institutional Review Board (IRB)-approved written informed consent document.
Study sites (1)
MO
- Washington University School of Medicine · St Louis, MO 63110Margaret Ferris, MD, PhD · Study contact · 314-454-6018 · youngm@wustl.eduMargaret Ferris, M.D., PhD · Principal investigatorMary Claire McGlynn, M.D. · Sub-investigatorJessica Cooke, PhD · Sub-investigatorMore trials in St Louis