Weight Gain in Pediatric Leukemia Survivors

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

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.

Sponsors & Collaborators

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• Margaret Ferris, MD, PhD · Washington University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-31

Primary Completion

2029-02-28

Completion

2029-02-28

Countries

• United States

Study Locations