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HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

Phase Not Applicable
Age: 5Years - 21Years
All Genders
ID05963971

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 institutions 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

Age: 5Years - 21Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

You will not qualify if you...

  • Currently receiving nutrition support such as enteral or parenteral nutrition
  • History of eating disorder

Research Team

P

Pooja Vyas, MPH

E

Elena J. Ladas, PhD, RD

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