Weight Gain in Pediatric Leukemia Survivors

Official title

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

Overview

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.

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.

Primary outcome measures

• Weight Z score [Time frame: Enrollment, during intervention (4 months after enrollment), end of intervention (6 months after enrollment (may be up to 9 months)), and 6 months after end of intervention (estimated total time frame of 12-15 months)]
• Changes in weight Z score [Time frame: From start of study through end of study (estimated total time frame 12-15 months)]
• BMI Z Score [Time frame: Enrollment, during intervention (4 months after enrollment), end of intervention (6 months after enrollment (may be up to 9 months)), and 6 months after end of intervention (estimated total time frame of 12-15 months)]
• Changes in BMI Z Score [Time frame: From start of study through end of study (estimated total time frame 12-15 months)]
• Changes in Cholesterol [Time frame: Enrollment, during intervention (4 months after enrollment), end of intervention (6 months after enrollment (may be up to 9 months)), and 6 months after end of intervention (estimated total time frame of 12-15 months)]
• Changes in HbA1c [Time frame: Enrollment, during intervention (4 months after enrollment), end of intervention (6 months after enrollment (may be up to 9 months)), and 6 months after end of intervention (estimated total time frame of 12-15 months)]
• Changes in Albumin [Time frame: Enrollment, during intervention (4 months after enrollment), end of intervention (6 months after enrollment (may be up to 9 months)), and 6 months after end of intervention (estimated total time frame of 12-15 months)]

Secondary outcome measures (7)

• Changes in activity intensity assessed by Fitbit Ace Smartwatch using the Freedson age-adjusted equation [Time frame: Enrollment, during intervention (4 months after enrollment), end of intervention (6 months after enrollment (may be up to 9 months)), and 6 months after end of intervention (estimated total time frame of 12-15 months)]
• Changes in activity levels as measured by PAQ-C assessments [Time frame: Enrollment, during intervention (4 months after enrollment), end of intervention (6 months after enrollment (may be up to 9 months)), and 6 months after end of intervention (estimated total time frame of 12-15 months)]
• Changes in activity levels as measured by PAQ-A assessments [Time frame: Enrollment, during intervention (4 months after enrollment), end of intervention (6 months after enrollment (may be up to 9 months)), and 6 months after end of intervention (estimated total time frame of 12-15 months)]
• Changes in health behaviors as measured by the Health Behaviors Survey [Time frame: Enrollment, during intervention (4 months after enrollment), end of intervention (6 months after enrollment (may be up to 9 months)), and 6 months after end of intervention (estimated total time frame of 12-15 months)]
• Changes in 24-hour dietary recall as measured by ASA24 [Time frame: Enrollment, during intervention (4 months after enrollment), end of intervention (6 months after enrollment (may be up to 9 months)), and 6 months after end of intervention. Estimated total time frame of 12-15 months.]
• Changes in health behaviors as measured by Childhood Feeding Questionnaire [Time frame: Enrollment, during intervention (4 months after enrollment), end of intervention (6 months after enrollment (may be up to 9 months)), and 6 months after end of intervention (estimated total time frame of 12-15 months)]
• Changes in Health Habits Survey [Time frame: Enrollment, during intervention (4 months after enrollment), end of intervention (6 months after enrollment (may be up to 9 months)), and 6 months after end of intervention (estimated total time frame of 12-15 months)]

Eligibility criteria

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/intellectual disabilities (such as Trisomy32, severe presentations of autism spectrum disorder) or significant mental illness (such as active suicidal ideation, psychotic symptoms, manic or hypomanic episodes, or severe substance use disorder) that may interfere with ability to participate in modified Family Based Therapy (FBT).
• Patients 10 and older must have a negative SCOFF screen for disordered eating (Score of 2 or more would disqualify the patient and require discussion with primary team)
• Must be able to understand and willing to sign an IRB-approved written informed consent document or be able to provide verbal assent along with written consent provided by a legally authorized representative.

Caregiver Eligibility Criteria:

• Self-reported as the primary caregiver of a pediatric patient diagnosed with ALL who is also participating in this study.
• Must be at least 18 years of age.
• Must be able to speak and understand English.
• 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 be able to understand willing to sign an Institutional Review Board (IRB)-approved written informed consent document.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 1 center

• Washington University School of Medicine — St Louis

Identifiers

NCT: NCT07374315 · 202512147

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗