A Bilingual Virtually-based Intervention (PEDALL) for the Prevention of Weight Gain in Childhood ALL Patients Considering Key Genetic and Sociodemographic Risk Factors

Launched by COLUMBIA UNIVERSITY · Jul 19, 2023

Keywords

ClinConnect Summary

This clinical trial, called PEDALL, is looking at a new way to help prevent weight gain in children and teenagers with acute lymphoblastic leukemia (ALL) who are undergoing maintenance chemotherapy. The study involves a six-month program delivered online, where participants will learn about healthy eating habits. By focusing on both diet and lifestyle, the researchers hope to help these young patients maintain a healthy weight during their treatment.

To be eligible for this study, participants need to be between 5 and 21 years old and currently receiving or planning to receive maintenance chemotherapy for ALL. They should also have a healthy weight based on their body measurements at the start of the trial. Additionally, participants must be fluent in either English or Spanish. The trial is currently recruiting, and those who join can expect support and resources to help them manage their health during this important time.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age: 5-21 years old at enrollment
• • Diagnosis and Treatment: Plan to receive or are receiving maintenance or continuation chemotherapy for B- or T-cell ALL, or mixed phenotype acute leukemia.
• • Timing: Patient is eligible for entry only if it is feasible to start the study intervention during the first month of the maintenance phase of ALL therapy.
• • Language: Fluency in English or Spanish
• • Weight Status: Healthy weight at baseline as determined by BMI z-score \< 1.04 and \>-1.04 for those under 5-18, and BMI between 19 and 25 for those \>18.
• • Ethnicity: Hispanic or Non-Hispanic of any race.
• Exclusion Criteria:
• • Patients on nutrition support (enteral or parenteral nutrition)
• • Patients with a history of eating disorder