Clinical trial
Weight Gain in Pediatric Leukemia Survivors
Opening soon · Not applicable · 1 countries · Registry ID NCT07374315
What this study is about
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.
Basic eligibility
Full registry criteria
Treatments and study arms
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.
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
FitBit Ace
Patients will be provided with a FitBit Ace. FitBit Ace will be worn by patients to track physical activity.
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.
Primary outcomes
Participant's weight Z score is a statistical value that indicates how the participant's weight for their age and sex compares to the average weight for that population which is obtained from Center for Disease Control (CDC) growth Charts
Participant's weight Z score is a statistical value that indicates how the participant's weight for their age and sex compares to the average weight for that population which is obtained from CDC growth Charts. Changes in weight Z score from start to end of the study will be analyzed by changes in summary statistics (mean, median, and standard deviation) across timepoints.
Participant's BMI Z score is a statistical value that indicates how the participant's BMI for their age and sex compares to the average BMI for that population which is obtained from CDC growth Charts
Participant's BMI Z score is a statistical value that indicates how the participant's BMI for their age and sex compares to the average BMI for that population which is obtained from CDC growth Charts. Changes in BMI Z score from start to end of the study will be analyzed by changes summary statistics (mean, median, and standard deviation) across timepoints.
Changes in cholesterol (total, LDL, and HDL levels) will be analyzed via summary statistics (means, medians, and standard deviation) at each of the endpoints.
Changes in HbA1c will be analyzed via summary statistics (means, medians, and standard deviation) at each of the endpoints.
Changes in albumin will be analyzed via summary statistics (means, medians, and standard deviation) at each of the endpoints.
Study locations
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