NCT07374315Not yet recruiting
Weight Gain in Pediatric Leukemia Survivors
A Family-based Intervention Approach to Address Weight Gain in Pediatric Leukemia Survivors
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 16 Jan 2026
- Start date
- 30 Nov 2026
- Primary completion date
- 31 Aug 2029
- Lead sponsor
- Washington University School of Medicine
- NCT number
- NCT07374315
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 30 Nov 2026 to the primary completion date, 31 Aug 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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.
Age in the registry: 6 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.