RECRUITING

A Bilingual Virtually-based Intervention (PEDALL) for the Prevention of Weight Gain in Childhood ALL Patients Considering Key Genetic and Sociodemographic Risk Factors

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Conditions

Acute Lymphoblastic LeukemiaObesityChildhood Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Bilingual Virtually-based Intervention (PEDALL) for the Prevention of Weight Gain in Childhood ALL Patients Considering Key Genetic and Sociodemographic Risk Factors

Quick Facts

Study Start:2024-03-19
Study Completion:2027-06-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05963971

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age: 5-21 years old at enrollment
  2. * Diagnosis and Treatment: Plan to receive or are receiving maintenance or continuation chemotherapy for B- or T-cell ALL, or mixed phenotype acute leukemia.
  3. * 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.
  4. * Language: Fluency in English or Spanish
  5. * 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.
  6. * Ethnicity: Hispanic or Non-Hispanic of any race.
  1. * Patients on nutrition support (enteral or parenteral nutrition)
  2. * Patients with a history of eating disorder

Contacts and Locations

Study Contact

Pooja Vyas, MPH
CONTACT
2123052631
psv2103@cumc.columbia.edu
Elena J. Ladas, PhD, RD
CONTACT
212-305-7835
ejd14@cumc.columbia.edu

Principal Investigator

Elena Ladas, PhD, RD
PRINCIPAL_INVESTIGATOR
Columbia University

Study Locations (Sites)

Columbia University Medical Center
New York, New York, 10032
United States

Collaborators and Investigators

Sponsor: Columbia University

  • Elena Ladas, PhD, RD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-19
Study Completion Date2027-06-23

Study Record Updates

Study Start Date2024-03-19
Study Completion Date2027-06-23

Terms related to this study

Keywords Provided by Researchers

  • Acute Lymphoblastic Leukemia
  • Obesity
  • Childhood Cancer

Additional Relevant MeSH Terms

  • Acute Lymphoblastic Leukemia
  • Obesity