Weight Maintenance Programs for Childhood Leukemia

MF
Overseen ByMargaret Ferris, MD, PhD
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Washington University School of Medicine
Must be taking: Maintenance chemotherapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two programs aimed at helping children with acute lymphoblastic leukemia (ALL) and their caregivers maintain a healthy weight. One program uses educational materials from the National Institutes of Health, while the other involves a modified guided self-help family intervention. The researchers aim to determine which program more effectively improves nutrition, physical activity, and other health habits. Children with ALL who are undergoing maintenance chemotherapy or have recently completed it, and who can engage in some exercise, might be suitable participants. As an unphased trial, this study provides a unique opportunity for families to contribute to research that could enhance health outcomes for children with ALL.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It seems likely that you can continue your standard chemotherapy treatment, as the trial is for those receiving or recently finished with maintenance chemotherapy.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that family-based programs for children with leukemia, such as the Modified Guided Self-Help Family Intervention (mL-GSH), are generally well-received. Studies indicate that parents often view these programs positively and actively participate, suggesting these interventions are safe.

One study on support for parents of children with acute lymphoblastic leukemia (ALL) found this approach effective, highlighting the safety and usefulness of similar family-focused programs.

Additionally, the NIH Educational Resources are popular programs designed to improve lifestyle habits. These have been available for a long time and are considered safe and effective for guiding families toward healthier living.

Both treatments in this trial are non-invasive and focus on education and support, making them safe options for children and their families dealing with leukemia.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments for weight maintenance in childhood leukemia survivors because they offer unique, family-centered approaches to improving health. Unlike traditional methods that might focus solely on diet or exercise, the Modified Guided Self-Help Family Intervention (mL-GSH) involves a comprehensive, six-session program targeting lifestyle changes within a family context, providing personalized support during clinic visits. On the other hand, the NIH Educational Resources arm offers accessible, online materials aimed at improving nutrition, physical activity, and sleep habits. These treatments are distinctive as they integrate easily into daily family life and provide ongoing support, potentially leading to better long-term health outcomes for young leukemia survivors.

What evidence suggests that this trial's weight maintenance programs could be effective for children with acute lymphoblastic leukemia?

Research has shown that family-based programs can help children lose weight, including those who have survived acute lymphoblastic leukemia (ALL). One study found that specially designed programs for children with ALL are practical and can lead to healthier weight. Another study discovered that self-help programs are as effective as group sessions for treating childhood obesity, offering families more flexibility. In this trial, participants in Arm B will complete the Modified Guided Self-Help Family Intervention (mL-GSH), which uses these findings to help children with ALL maintain a healthy weight through structured family support. Meanwhile, participants in Arm A will receive NIH Educational Resources, which provide guidance to improve nutrition, increase physical activity, limit screen time, and enhance sleep.26789

Who Is on the Research Team?

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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.
See 7 more

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?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Arm B: Modified Guided Self-Help Family Intervention (mL-GSH)Experimental Treatment3 Interventions
Group II: Arm A: Educational ResourcesActive Control3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials
2,027
Recruited
2,353,000+

Citations

Fit4Life: A Weight Loss Intervention for Children who ... - PMC

We demonstrated acceptable feasibility of a WMI tailored for overweight and obese children surviving ALL utilizing a multimodal technology approach.

Weight Maintenance Programs for Childhood Leukemia

This is a trial assessing the efficacy of two weight maintenance programs for children with acute lymphoblastic leukemia (ALL) and the patients' caregivers.

Family-Based Behavioral Treatment for Childhood Obesity ...

Family-based treatment can be successfully implemented in pediatric primary care settings and leads to improved weight loss outcomes.

Adaptation of Family-Based Healthy Weight Program ... - PMC

A pilot trial of FBT for children who survived ALL and their parents is underway to evaluate acceptability, feasibility, and preliminary efficacy.

Guided Self-Help vs Group Treatment for Children With Obesity

This study demonstrated that a guided self-help version of FBT is noninferior to a group-based 6-month FBT program for weight loss among ...

Knowledge, attitude, and practice toward family-based ... - PMC

Parents of children with leukemia demonstrated inadequate knowledge, but positive attitudes and proactive practices toward family-based treatment for leukemia.

Nursing interventions for pediatric patients with cancer and ...

This scoping review found that nursing interventions hold a potential to support families with childhood cancer across the cancer continuum.

Study Details | NCT05410574 | Family-Based Behavioral ...

A single-arm, non-randomized four-month trial of the adapted family-based behavioral weight loss treatment (FBT) intervention will be conducted.

mHealth Supportive Care Intervention for Parents of Children ...

The mHealth intervention in supporting parents of children with ALL is effective. This study is informative for other future studies on ...