Weight Maintenance Programs for Childhood Leukemia

Overseen By Margaret Ferris, MD, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Must be taking: Maintenance chemotherapy

Disqualifiers: Severe developmental delay, significant mental illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Margaret Ferris, MD, PhD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for children aged 6-18 with acute lymphoblastic leukemia (ALL), either on maintenance chemotherapy or within 6 months post-treatment. Participants must speak English, have a caregiver involved, and be able to do some exercise. Those with severe developmental delays, significant mental illness, or signs of disordered eating are excluded.

Inclusion Criteria

I am between 6 and 18 years old.

I have been diagnosed with acute lymphoblastic leukemia (ALL).

I am currently on, or have recently finished, standard chemotherapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants and caregivers are randomized to either an educational intervention using NIH resources or a Modified Guided Self-Help Family Intervention for leukemia survivors

6-9 months

Monthly clinic appointments

Follow-up

Participants are monitored for changes in weight, BMI, cholesterol, HbA1c, and other health metrics

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Modified Guided Self-Help Family Intervention
• NIH Educational Resources

Trial Overview

The study compares two weight maintenance programs: one uses NIH educational resources for kids and teens; the other is a family intervention program (mL-GSH). Both groups will use activity trackers and undergo obesity biometrics along with nutrition and physical activity assessments.

How Is the Trial Designed?

Group I: Arm B: Modified Guided Self-Help Family Intervention (mL-GSH) Experimental Treatment 3 Interventions

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).

Group II: Arm A: Educational Resources Active Control 3 Interventions

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.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+