NCT05963971 A Bilingual Virtually-based Intervention (PEDALL) for the Prevention of Weight Gain in Childhood ALL Patients Considering Key Genetic and Sociodemographic Risk Factors
| NCT ID | NCT05963971 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | Acute Lymphoblastic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 376 participants |
| Start Date | 2024-03-19 |
| Primary Completion | 2026-12-23 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 376 participants in total. It began in 2024-03-19 with a primary completion date of 2026-12-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
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
Contact & Investigator
Elena Ladas, PhD, RD
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT05963971 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 21 Years, studying Acute Lymphoblastic Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05963971 currently recruiting?
Yes, NCT05963971 is actively recruiting participants. Contact the research team at psv2103@cumc.columbia.edu for enrollment information.
Where is the NCT05963971 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05963971 clinical trial?
NCT05963971 is sponsored by Columbia University. The principal investigator is Elena Ladas, PhD, RD at Columbia University. The trial plans to enroll 376 participants.
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