Weight Gain in Pediatric Leukemia Survivors

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07374315
Status
Not Yet Recruiting

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Conditions

  • Leukemia
  • Pediatric Acute Lymphoblastic Leukemia
  • Pediatric Acute Lymphoblastic Leukemia in Remission
  • Pediatric Obesity

Eligibility Criteria

Sex
ALL
Age
6 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Modified Guided Self-Help Family Intervention — BEHAVIORAL
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    Patients will be provided with a FitBit Ace. FitBit Ace will be worn by patients to track physical activity.
  • WashU Extended Learning Canvas — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
Feb 28, 2029
Completion
Feb 28, 2029

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Arm A: Educational Resources
    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.
  • Experimental: Arm B: Modified Guided Self-Help Family Intervention (mL-GSH)
    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).

Primary Outcome Measure

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Margaret Ferris, MD, PhD
[email protected]
314-454-6018
Margaret Ferris, M.D., PhD (PRINCIPAL_INVESTIGATOR)
Mary Claire McGlynn, M.D. (SUB_INVESTIGATOR)
Jessica Cooke, PhD (SUB_INVESTIGATOR)
Feng Gao, PhD (SUB_INVESTIGATOR)

Find similar trials in St Louis, MO

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Washington University School of Medicine· St Louis, MO

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