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.
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.
None
Parallel
Modified Guided Self-Help Family Intervention
BehavioralPatients 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
BehavioralPatients 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
BehavioralPatients will be provided with a FitBit Ace. FitBit Ace will be worn by patients to track physical activity.
WashU Extended Learning Canvas
BehavioralAll 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.
Weight Z score
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
Changes in weight Z score
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.
BMI Z Score
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
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 activity intensity assessed by Fitbit Ace Smartwatch using the Freedson age-adjusted equation
The Freedson age-adjusted equation is used to estimate maximum heart rate based on age and then is used to classify activity intensity by the heart rate of the activity.
Changes in activity levels as measured by PAQ-C assessments
Activity levels will be assessed by participants' changes in scores across different timepoints on Physical Activity Questionnaire for Older Children (PAQ-C). The PAQ-C is a self-administered, 7 day recall questionnaire designed to assess physical activity of children by proving a summary score of moderate to vigorous physical activity (MVPA). The mean PAQ-C score is interpreted as follows: 1.0-1.9 low physical activity, 2.0-2.9 moderate-low activity, 3.0-3.9 moderate activity, and 4.0-5.0 high activity. A higher score indicates a higher activity level.
Changes in activity levels as measured by PAQ-A assessments
Activity levels will be assessed by participants' changes in scores across different timepoints on Physical Activity Questionnaire for Adolescents (PAQ-A). The PAQ-A is a self-administered, 7 day recall questionnaire designed to assess physical activity of adolescents by proving a summary score of moderate to vigorous physical activity (MVPA). The mean PAQ-A score is interpreted as follows: 1.0-1.9 low physical activity, 2.0-2.9 moderate-low activity, 3.0-3.9 moderate activity, and 4.0-5.0 high activity. A higher score indicates a higher activity level.
Changes in health behaviors as measured by the Health Behaviors Survey
The health behaviors survey assesses average daily activity level, screen time, sweetened beverage consumption, and fruit and vegetables consumption to determine if patients are compliant with American Academy of Pediatrics Recommendation. 44% of childhood cancer survivors are active more than 60 minutes a day, 40% engage in less than 1 hour of screen time, 34% consume sweetened beverages and 4% consume more than one serving of fruits and vegetables.
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