A virtual dietary education program to prevent weight gain in children with leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of a six-month virtually delivered dietary education intervention called PEDALL aimed at preventing overweight and obesity in children and adolescents undergoing maintenance chemotherapy for acute lymphoblastic leukemia (ALL). Participants will be randomized to receive either the PEDALL intervention or standard care, with the PEDALL group receiving 26 hours of specialized nutrition education and counseling in English or Spanish. The study focuses on children and adolescents who are healthy weight at diagnosis, as they are at the highest risk for weight gain during treatment. The intervention seeks to address the significant clinical ramifications associated with obesity in this population.

Why it matters

Who can join: the full rules

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

Where it's running

• Columbia University Medical Center
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Elena Ladas, PhD, RD — Columbia University
• Study coordinator: Pooja Vyas, MPH
• Email: psv2103@cumc.columbia.edu
• Phone: 2123052631

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.