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 |
Trial Parameters
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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
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