Actively Recruiting
A Bilingual Virtually-based Intervention (PEDALL) for the Prevention of Weight Gain in Childhood ALL Patients Considering Key Genetic and Sociodemographic Risk Factors
Led by Columbia University · Updated on 2025-10-07
376
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of a six-month virtually-delivered dietary education program called PEDALL to prevent overweight and obesity during maintenance chemotherapy in children and adolescents with acute lymphoblastic leukemia (ALL). The study focuses on English and Spanish speaking families and considers key genetic and sociodemographic risk factors that may affect weight gain during treatment. Participants will be randomly assigned to one of two groups: the PEDALL intervention group or the standard of care (SOC) group. The PEDALL group will receive 26 contact hours of specialized nutrition education through weekly one-hour virtual sessions over six months. The SOC group will receive printed educational materials and nutritional care according to their institution's usual practices. During the study, participants and their caregivers will engage in nutrition education and counseling sessions. Researchers will assess weight status, body mass index trajectories, lifestyle behaviors, and the influence of genetic and sociodemographic factors over time. The main goal is to prevent unhealthy weight gain during maintenance chemotherapy and improve long-term health outcomes for childhood ALL survivors. The study will last up to 3.5 years for primary outcomes, with additional follow-up extending to four years.
CONDITIONS
Brief Title
A Bilingual Virtually-based Intervention (PEDALL) for the Prevention of Weight Gain in Childhood ALL Patients Considering Key Genetic and Sociodemographic Risk Factors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 5 and 21 years old at enrollment
- Plan to receive or currently receiving maintenance or continuation chemotherapy for B- or T-cell acute lymphoblastic leukemia or mixed phenotype acute leukemia
- Able to start the study intervention during the first month of the maintenance phase of ALL therapy
- Fluent in English or Spanish
- Healthy weight at baseline based on BMI z-score between -1.04 and 1.04 for ages 5-18, or BMI between 19 and 25 for those over 18
- Hispanic or Non-Hispanic of any race
You will not qualify if you...
- Currently receiving nutrition support such as enteral or parenteral nutrition
- History of eating disorder
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 months
Participants receive a six-month virtually delivered dietary education intervention or standard nutritional education during maintenance chemotherapy for ALL.
Weekly virtual nutrition education sessions for 6 months
Duration - Up to 1 year post-treatment
Participants are monitored for weight and lifestyle changes up to one year after completing treatment for ALL.
Trial Site Locations
Total: 1 location
1
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
Research Team
P
Pooja Vyas, MPH
E
Elena J. Ladas, PhD, RD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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