Clinical Trial Details
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Phase N/AInterventional
A Bilingual Virtually-based Intervention (PEDALL) for the Prevention of Weight Gain in Childhood ALL Patients Considering Key Genetic and Sociodemographic Risk Factors
Protocol: STUDY00007682NCT: NCT05963971
Overview
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
| Ages | 5 Years - 21 Years |
| Sex | All |
| Healthy Volunteers | No |
| Age Groups | Child, Adult |
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