Status:
RECRUITING
A Bilingual Virtually-based Intervention (PEDALL) for the Prevention of Weight Gain in Childhood ALL Patients Considering Key Genetic and Sociodemographic Risk Factors
Lead Sponsor:
Columbia University
Collaborating Sponsors:
United States Department of Defense
Conditions:
Acute Lymphoblastic Leukemia
Obesity
Eligibility:
All Genders
5-21 years
Phase:
NA
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 maintenan...
Detailed Description
Acute lymphoblastic leukemia (ALL) has been referred to as a "pre-obese state", with many studies describing the onset of obesity during treatment. Weight gain typically begins within the first month ...
Eligibility Criteria
Inclusion
- 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
- Patients on nutrition support (enteral or parenteral nutrition)
- Patients with a history of eating disorder
Key Trial Info
Start Date :
March 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 23 2027
Estimated Enrollment :
376 Patients enrolled
Trial Details
Trial ID
NCT05963971
Start Date
March 19 2024
End Date
June 23 2027
Last Update
October 7 2025
Active Locations (1)
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1
Columbia University Medical Center
New York, New York, United States, 10032