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

Recruiting now · Not applicable

Conditions studied: Acute Lymphoblastic Leukemia, Obesity

In brief

The purpose of this study is determine the effectiveness of a six-month virtually-delivered dietary education intervention (PEDALL) on the prevention of overweight and obesity (OW/OB) during maintenance chemotherapy in children and adolescents with acute lymphoblastic leukemia (ALL).

Key facts

Study ID

NCT05963971

Run by

Columbia University

People needed

376

Starts

2024-03-19

Expected to finish

2027-06-23

Last updated by the study team

2025-10-07

Who can join

Age: 5 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patients on nutrition support (enteral or parenteral nutrition)
• Patients with a history of eating disorder

Where it is running

• Columbia University Medical Center — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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