A virtual dietary education program to prevent weight gain in children with leukemia
A Bilingual Virtually-based Intervention (PEDALL) for the Prevention of Weight Gain in Childhood ALL Patients Considering Key Genetic and Sociodemographic Risk Factors
NA · Columbia University · NCT05963971
This study is testing a virtual nutrition program to see if it can help children with leukemia avoid gaining weight while they are receiving treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 376 (estimated) |
| Ages | 5 Years to 21 Years |
| Sex | All |
| Sponsor | Columbia University (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05963971 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a six-month virtually delivered dietary education intervention called PEDALL aimed at preventing overweight and obesity in children and adolescents undergoing maintenance chemotherapy for acute lymphoblastic leukemia (ALL). Participants will be randomized to receive either the PEDALL intervention or standard care, with the PEDALL group receiving 26 hours of specialized nutrition education and counseling in English or Spanish. The study focuses on children and adolescents who are healthy weight at diagnosis, as they are at the highest risk for weight gain during treatment. The intervention seeks to address the significant clinical ramifications associated with obesity in this population.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 5-21 years with a diagnosis of acute lymphoblastic leukemia who are healthy weight at baseline and fluent in English or Spanish.
Not a fit: Patients on nutrition support or with a history of eating disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the incidence of obesity in childhood cancer survivors, improving long-term health outcomes.
How similar studies have performed: Other studies have shown success with dietary interventions in similar populations, indicating potential for positive outcomes with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
New York, New York
- Columbia University Medical Center — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Elena Ladas, PhD, RD — Columbia University
- Study coordinator: Pooja Vyas, MPH
- Email: psv2103@cumc.columbia.edu
- Phone: 2123052631
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Lymphoblastic Leukemia, Obesity, Childhood Cancer