Weight Gain in Pediatric Leukemia Survivors

The Washington University

Status: Not yet enrolling

Conditions: Pediatric Acute Lymphoblastic Leukemia in Remission; Pediatric Acute Lymphoblastic Leukemia; Pediatric Obesity; Leukemia

Treatments: Behavioral: FitBit Ace; Behavioral: Modified Guided Self-Help Family Intervention; Behavioral: WashU Extended Learning Canvas; Behavioral: NIH Educational Resources

Study type: Interventional

Funder types: Other

Identifiers

NCT07374315

202512147

Details and patient eligibility

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

80 participants in 2 patient groups

Arm A: Educational Resources

Active Comparator group

Description:

Participants will be provided direction to NIH educational resources over the course of the intervention. Both programs provide resources to improve nutrition, increase physical activity, limit screen time, and improve sleep and consist of online, free, assessable educational materials. Patients and caregivers will be reminded of this resource at their monthly clinic appointments for 6 months after their first study visit.

Treatment:

Behavioral: NIH Educational Resources

Behavioral: WashU Extended Learning Canvas

Behavioral: FitBit Ace

Arm B: Modified Guided Self-Help Family Intervention (mL-GSH)

Experimental group

Description:

Participants will complete the Modified Guided Self-Help Family Intervention for survivors of leukemia (mL-GSH). ML-GSH is a six-session intervention to be delivered during appointments. Patients will have 6 months to complete the curriculum (may be up to 9 months to account for scheduling concerns).

Treatment:

Behavioral: WashU Extended Learning Canvas

Behavioral: Modified Guided Self-Help Family Intervention

Behavioral: FitBit Ace