A Family-based Intervention Approach to Address Weight Gain in Pediatric Leukemia Survivors
Washington University School of Medicine
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.
Eligibility
- Age range
- 6+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- BehavioralModified 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.
- BehavioralNIH 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
- BehavioralFitBit Ace
Patients will be provided with a FitBit Ace. FitBit Ace will be worn by patients to track physical activity.
- BehavioralWashU 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.
Location
- Washington University School of MedicineSt Louis, Missouri