~216 spots leftby Dec 2026

PEDALL Program for Childhood Acute Lymphoblastic Leukemia Weight Management

(PEDALL Trial)

EC
EJ
PV
Overseen ByPooja Vyas, MPH
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Columbia University
Disqualifiers: Nutrition support, Eating disorder, others
No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests an online nutrition education program called PEDALL for children and teens with acute lymphoblastic leukemia (ALL) who are undergoing maintenance chemotherapy. The goal is to prevent them from becoming overweight or obese, which is a common issue during treatment. By teaching healthy eating habits and providing regular support, the program aims to help these young patients maintain a healthy weight.

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 data supports the effectiveness of the PEDALL treatment for weight management in children with acute lymphoblastic leukemia?

Research shows that lifestyle interventions, including exercise and dietary changes, can help manage weight in children with acute lymphoblastic leukemia. A study found that a 12-week lifestyle program helped children improve their diet, suggesting that similar interventions like PEDALL could be effective in preventing weight gain.12345

Is the PEDALL Program for Childhood Acute Lymphoblastic Leukemia Weight Management safe for children?

Exercise interventions for pediatric cancer patients, including those with leukemia, have shown good adherence and no adverse events, suggesting they are generally safe for children.13678

How is the PEDALL treatment different from other treatments for childhood acute lymphoblastic leukemia?

The PEDALL treatment is unique because it focuses on preventing weight gain in children with acute lymphoblastic leukemia through a bilingual, virtually-based lifestyle intervention, which includes web-based sessions and phone calls with a lifestyle coach. This approach is different from traditional treatments that primarily focus on medical interventions, as it emphasizes early lifestyle changes to manage weight and improve long-term health outcomes.123910

Research Team

EL

Elena Ladas, PhD, RD

Principal Investigator

Columbia University

Eligibility Criteria

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

I am undergoing or planning to undergo maintenance chemotherapy for acute lymphoblastic leukemia.
Ethnicity: Hispanic or Non-Hispanic of any race
I can start the study treatment within the first month of my maintenance therapy for ALL.
See 3 more

Exclusion Criteria

I am receiving nutrition through a feeding tube or IV.
Patients with a history of eating disorder

Trial Timeline

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

Treatment Details

Interventions

  • PEDALL (Behavioral Intervention)
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: PEDALLExperimental Treatment1 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 Control1 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.

Find a Clinic Near You

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+

Findings from Research

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.
Feasibility and initial effectiveness of home exercise during maintenance therapy for childhood acute lymphoblastic leukemia.Esbenshade, AJ., Friedman, DL., Smith, WA., et al.[2022]
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.
Early Lifestyle Intervention for Obesity Prevention in Pediatric Survivors of Acute Lymphoblastic Leukemia.Zhang, FF., Kelly, M., Du, M., et al.[2020]
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.
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]

References

Feasibility and initial effectiveness of home exercise during maintenance therapy for childhood acute lymphoblastic leukemia. [2022]
Early Lifestyle Intervention for Obesity Prevention in Pediatric Survivors of Acute Lymphoblastic Leukemia. [2020]
Exercise program for children and adolescents with leukemia and lymphoma during treatment: A comprehensive review. [2019]
Therapy-related changes in body size in Hispanic children with acute lymphoblastic leukemia. [2021]
Overweight in childhood cancer patients at diagnosis and throughout therapy: A multicentre cohort study. [2020]
Exercise interventions for patients with pediatric cancer during inpatient acute care: A systematic review of literature. [2022]
The effect of oral nutrition supplements and appetite stimulants on weight status among pediatric cancer patients: A systematic review. [2023]
Clinical field testing of an enhanced-activity intervention in hospitalized children with cancer. [2007]
Malnutrition screening and treatment in pediatric oncology: a scoping review. [2022]
The effect of an aerobic exercise program on the quality of life in children with cancer. [2019]