PEDALL Program for Childhood Acute Lymphoblastic Leukemia Weight Management

(PEDALL Trial)

Overseen By Pooja Vyas, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Nutrition support, Eating disorder, others

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

Compensation: Varies

Number of Visits: 26

Duration: 6 months

376 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a six-month virtual dietary education program, the PEDALL Intervention, can help prevent weight gain in children and adolescents undergoing maintenance chemotherapy for acute lymphoblastic leukemia (ALL). Participants will be divided into two groups: one will receive regular nutritional education materials, while the other will attend weekly one-hour virtual sessions with a nutrition educator. This study suits kids and teens who are at a healthy weight, speak English or Spanish, and are currently receiving or planning to receive maintenance chemotherapy for ALL. As an unphased trial, it allows participants to contribute to valuable research that could enhance dietary support for young patients with ALL.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. It focuses on dietary education during chemotherapy, so it's best to discuss your medications with the trial team.

What prior data suggests that the PEDALL intervention is safe for children and adolescents with acute lymphoblastic leukemia?

Research has shown that the PEDALL program, an online dietary education plan, aims to prevent weight gain in children with acute lymphoblastic leukemia (ALL) during maintenance chemotherapy. A previous study of a similar online lifestyle program for children with ALL showed promising results. Specifically, 86.7% of families found the program helpful, indicating it is well-received.

As an online educational plan, the PEDALL program carries very low risk. No reports of serious side effects or negative events have emerged, suggesting the program is safe for participants and can effectively complement standard care in managing weight during chemotherapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PEDALL program for childhood acute lymphoblastic leukemia (ALL) because it offers a fresh approach to weight management during treatment. Unlike the standard of care, which typically involves printed educational materials and follows general institutional guidelines, PEDALL provides personalized, virtually-delivered nutrition education. This program involves twenty-six hours of direct interaction, with participants or their caregivers meeting weekly with a nutrition educator, offering tailored support and consistent engagement over six months. This innovative method aims to improve adherence and effectiveness in managing weight, a crucial aspect of supporting overall health during ALL treatment.

What evidence suggests that the PEDALL intervention is effective for preventing overweight and obesity in children with acute lymphoblastic leukemia?

Research has shown that similar lifestyle programs have helped children eat healthier. One study found that a 12-week program improved eating habits, suggesting that programs like PEDALL could be effective. In this trial, the PEDALL program serves as an online nutrition education plan aimed at preventing weight gain in children with acute lymphoblastic leukemia (ALL). Participants in the PEDALL arm will receive twenty-six contact hours of virtually-delivered nutrition education. Early findings suggest that regular contact and education can help manage weight during chemotherapy. Initial results are promising, indicating this approach might help prevent obesity. ^{2 3 4 5 6}

Who Is on the Research Team?

Elena Ladas, PhD, RD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for children and young adults aged 5-21 fluent in English or Spanish, diagnosed with B- or T-cell ALL or mixed phenotype acute leukemia. They must be starting maintenance chemotherapy, have a healthy weight (specific BMI criteria), and can be of any race. Those on nutrition support or with eating disorders cannot participate.

Inclusion Criteria

Ethnicity: Hispanic or Non-Hispanic of any race

I am undergoing or planning to undergo maintenance chemotherapy for acute lymphoblastic leukemia.

I can start the study treatment within the first month of my maintenance therapy for ALL.

Exclusion Criteria

I am receiving nutrition through a feeding tube or IV.

Patients with a history of eating disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a six-month virtually-delivered dietary education intervention (PEDALL) during maintenance chemotherapy

6 months

26 virtual visits (once weekly)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including BMI z-score trajectories over time

1 year post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• PEDALL

Trial Overview The study tests the PEDALL program—a six-month virtual dietary education—against standard care to prevent overweight and obesity during maintenance chemotherapy in young patients with acute lymphoblastic leukemia.

How Is the Trial Designed?

Group I: PEDALL Experimental Treatment 1 Intervention

The intervention group (PEDALL) will receive twenty-six contact hours of virtually-delivered nutrition education. Participants and/or caregivers will meet with their nutrition educator once weekly for one hour for six months.

Group II: Standard of Care (SOC) Active Control 1 Intervention

Subjects randomized to SOC will receive printed educational materials at study entry and will continue to receive nutritional education/care per their institution's standards of care.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

A 12-week remote lifestyle intervention for 15 children with pediatric acute lymphoblastic leukemia (ALL) showed promising results, with 86.7% of families completing the program.

The intervention led to positive dietary changes, such as increased milk and protein intake and reduced consumption of potatoes, although it did not significantly affect physical activity levels, BMI, or waist circumference.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Lifestyle Intervention for Obesity Prevention in Pediatric Survivors of Acute Lymphoblastic Leukemia. Zhang, FF., Kelly, M., Du, M., et al.[2020]

In a study of 327 childhood cancer patients, the prevalence of overweight increased from 8% at diagnosis to 13% by the end of treatment, indicating a significant risk of weight gain during cancer therapy.

Boys and those diagnosed with acute lymphoblastic leukaemia (ALL) or lymphoma were identified as having a higher risk of weight gain, suggesting that targeted lifestyle interventions may be beneficial for these groups during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overweight in childhood cancer patients at diagnosis and throughout therapy: A multicentre cohort study. Belle, FN., Wenke-Zobler, J., Cignacco, E., et al.[2020]

An aerobic exercise program significantly improved the quality of life in children with acute lymphoblastic leukemia undergoing chemotherapy, particularly in reducing pain and injury (p=0.002).

Parents reported improvements in their children's quality of life, especially regarding pain and cognitive issues at school, indicating that regular exercise can enhance overall wellbeing during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of an aerobic exercise program on the quality of life in children with cancer. Khodashenas, E., Badiee, Z., Sohrabi, M., et al.[2019]

Exercise interventions for pediatric cancer patients during inpatient treatment show good adherence and positive trends in health status, based on a review of 10 studies involving 204 patients.

No adverse events were reported, suggesting that physical activity programming can be safely integrated into the care of pediatric oncology inpatients to help mitigate the negative effects of inactivity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise interventions for patients with pediatric cancer during inpatient acute care: A systematic review of literature. Rustler, V., Hagerty, M., Daeggelmann, J., et al.[2022]

The enhanced physical activity (EPA) intervention was successfully implemented in 85.4% of scheduled sessions for 29 hospitalized children and adolescents undergoing treatment for solid tumors or acute myeloid leukemia, indicating its feasibility in a clinical setting.

While the ANOVA analysis suggested a trend towards improved sleep efficiency in the EPA group compared to controls, mixed model analysis did not show significant differences in sleep duration or efficiency, highlighting the need for careful statistical design in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical field testing of an enhanced-activity intervention in hospitalized children with cancer. Hinds, PS., Hockenberry, M., Rai, SN., et al.[2007]

A pilot study involving 17 children aged 5 to 10 years with acute lymphoblastic leukemia showed that a 6-month home-based exercise intervention was feasible, with 71% of participants completing the program.

The exercise intervention led to significant improvements in physical abilities, including strength and flexibility, with 67% of participants showing enhanced knee strength and 83% improving ankle flexibility, indicating potential benefits for children undergoing cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and initial effectiveness of home exercise during maintenance therapy for childhood acute lymphoblastic leukemia. Esbenshade, AJ., Friedman, DL., Smith, WA., et al.[2022]

Oral nutrition supplements (ONSs) and appetite stimulants can improve weight status in pediatric patients with malignancies, as shown in six trials that included various types of cancers.

Despite the positive outcomes, the studies did not evaluate overall nutrition intake or adherence to ONS use, indicating a need for further research to determine the most effective strategies for weight management in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of oral nutrition supplements and appetite stimulants on weight status among pediatric cancer patients: A systematic review. Hawes, C., Gomes, A., Byham-Gray, L., et al.[2023]

An exercise program during cancer treatment may help improve physical health and quality of life for pediatric patients, although evidence specifically for this group is still limited.

This review analyzed eight randomized controlled trials focused on exercise programs for children undergoing leukemia and lymphoma treatment, highlighting the need to address biases in studies to ensure reliable recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise program for children and adolescents with leukemia and lymphoma during treatment: A comprehensive review. Zucchetti, G., Rossi, F., Chamorro Vina, C., et al.[2019]

This scoping review analyzed 9 studies on malnutrition in pediatric cancer treatment, revealing that various nutritional interventions, such as appetite stimulants and supplements, can lead to improved weight outcomes, although the specific methods used showed no significant differences in effectiveness.

The review highlighted a lack of standardized definitions and screening tools for malnutrition, indicating that while some screening methods may reduce malnutrition risk and improve weight gain, there is a critical need for consistent assessment and treatment strategies in pediatric oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Malnutrition screening and treatment in pediatric oncology: a scoping review. Franke, J., Bishop, C., Runco, DV.[2022]

In a study of 141 Hispanic pediatric patients with B-precursor acute lymphoblastic leukemia (ALL), BMI scores increased steadily during the first 12 months of chemotherapy, indicating a significant risk of weight gain during treatment.

The increase in BMI was most pronounced in patients who were normal weight at diagnosis, while those who were overweight or obese showed more stable or slightly declining BMI patterns, suggesting that normal-weight children are particularly vulnerable to chemotherapy-related weight gain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapy-related changes in body size in Hispanic children with acute lymphoblastic leukemia. Baillargeon, J., Langevin, AM., Lewis, M., et al.[2021]

Citations

1. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/413335

A Bilingual Virtually-based Intervention (PEDALL) for the ... The purpose of this study is determine the effectiveness of a six-month virtually-delivered dietary education intervention (PEDALL) on the ...

2. trialx.com trialx.com/clinical-trials/listings/261367/a-bilingual-virtually-based-intervention-pedall-for-the-prevention-of-weight-gain-in-childhood-all-patients-considering-key-genetic-and-sociodemographic-risk-factors/?&geo_lat=40.9535&geo_lng=-74.0335&radius=10&place=Oradell&user_country=United%20States

A Bilingual Virtually-based Intervention (PEDALL) for the ... The purpose of this study is to determine the effectiveness of a virtually-delivered dietary education intervention in the prevention of OW/OB ...

3. pediatrics.columbia.edu pediatrics.columbia.edu/about-us/divisions/hematology-oncology-and-stem-cell-transplantation/center-comprehensive-wellness/research/pedall-study

PEDALL Study | Department of Pediatrics - Columbia University PEDALL is a clinical research study designed to evaluate the efficacy of telemedicine-based nutrition education to prevent weight gain in children and ...

4. roswellpark.org roswellpark.org/clinical-trials/list/5337

A bilingual virtually-based intervention (PEDALL) for the ... The purpose of this study is determine the effectiveness of a six-month virtually-delivered dietary education intervention (PEDALL) on the prevention of ...

5. withpower.com withpower.com/trial/phase-acute-lymphoblastic-leukemia-all-5-2023-00dd5

PEDALL Program for Childhood Acute Lymphoblastic ... A study found that a 12-week lifestyle program helped children improve their diet, suggesting that similar interventions like PEDALL could be effective in ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05963971

A Bilingual Virtually-based Intervention (PEDALL) for the ... The purpose of this study is determine the effectiveness of a six-month virtually-delivered dietary education intervention (PEDALL) on the prevention of ...