NCT07374315

Weight Gain in Pediatric Leukemia Survivors

A Family-based Intervention Approach to Address Weight Gain in Pediatric Leukemia Survivors

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Leukemia
• Pediatric Acute Lymphoblastic Leukemia
• Pediatric Acute Lymphoblastic Leukemia in Remission
• Pediatric Obesity

Interventions

Type	Name	Description
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.
BEHAVIORAL	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
BEHAVIORAL	FitBit Ace	Patients will be provided with a FitBit Ace. FitBit Ace will be worn by patients to track physical activity.
BEHAVIORAL	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.

Timeline

• Start date: 2026-03-31
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2026-01-28
• Last updated: 2026-02-12

Locations

1 site across 1 country: United States