A Bilingual Virtually-based Intervention (PEDALL) for the Prevention of Weight Gain in Childhood ALL Patients Considering Key Genetic and Sociodemographic Risk Factors
Recruiting · NCT05963971 · Interventional (participants receive a specific treatment) · Lead sponsor: Columbia University
View the official record on ClinicalTrials.gov →Interventions studied
PEDALLStandard of care
What this trial is about
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 take part
Age range
5 Years to 21 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed across 1 US state.
- Columbia University Medical Center - New York, New York, United States