A Bilingual Virtually-based Intervention (PEDALL) for the Prevention of Weight Gain in Chi
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).
| Condition(s) | Acute Lymphoblastic Leukemia, Obesity |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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). |
| Who can participate | 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 |
| Ages | 5 Years to 21 Years |
| Sex | All |
| Lead sponsor | Columbia University |
| Locations | New York, New York, United States |
| Start date | 2024-03-19 |
| NCT ID | NCT05963971 |
| Official listing | https://clinicaltrials.gov/study/NCT05963971 |