Home › Acute Lymphoblastic Leukemia › NCT05963971

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

Who can join

Ages 5 to 21 · All sexes

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

About the study

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).

What is being tested

• PEDALL (behavioral)
• Standard of care (other)

Sponsor: Columbia University · Participants: 376 · Started: Mar 19, 2024

Contact the study team

• Pooja Vyas, MPH · Phone: 2123052631
• Elena J. Ladas, PhD, RD · Phone: 212-305-7835

Official record on ClinicalTrials.gov — NCT05963971

Locations in the U.S.

Conditions

• Acute Lymphoblastic Leukemia
• Obesity
• Cancer (all types)

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.