Recruiting

PEDALL

Sponsor:

Columbia University

Code:

NCT05963971

Conditions

Acute Lymphoblastic Leukemia

Obesity

Eligibility Criteria

Sex: All

Age: 5 - 21

Healthy Volunteers: Not accepted

Interventions

PEDALL

Standard of care

Study Details

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 maintenance chemotherapy in children and adolescents with acute lymphoblastic leukemia (ALL).

Conditions

Acute Lymphoblastic Leukemia

Obesity

Study ID

NCT05963971

Start date

Mar 19, 2024

Status verified date

Oct, 2025

Completion date

Jun 23, 2027

Anticipated

Primary completion date

Dec 23, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 21

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

376 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: PEDALL

The intervention group (PEDALL) will receive twenty-six contact hours of virtually-delivered nutrition education. Participants and/or caregivers will meet with their nutrition educator once weekly for one hour for six months.

active comparator: Standard of Care (SOC)

Subjects randomized to SOC will receive printed educational materials at study entry and will continue to receive nutritional education/care per their institution's standards of care.

Interventions

PEDALL

Twenty-six hour nutrition education intervention delivered virtually over a six month period

Standard of care

Nutrition education per institutional standard of care

Primary outcome measure

  • To prevent the development of OW/OB during maintenance chemotherapy using a six-month virtually delivered dietary education intervention (PEDALL) in English and Spanish speaking families of children and adolescents undergoing treatment for ALL. [ Time Frame: 3.5 years ]

Central Contacts and Locations

Central contacts

Pooja Vyas, MPH

2123052631psv2103@cumc.columbia.edu

Elena J. Ladas, PhD, RD

212-305-7835ejd14@cumc.columbia.edu

Locations

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Pooja Vyas, MPH

212-305-2631psv2103@cumc.columbia.edu

Elena Ladas, PhD, RD

212-305-7835ejd14@cumc.columbia.edu

Principal Investigator:

Elena Ladas, PhD, RD

More Information

Sponsor

Columbia University

Last update posted

Oct 7, 2025

Last verified

Oct, 2025

Keywords

  • Acute Lymphoblastic Leukemia
  • Obesity
  • Childhood Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Columbia University on 2025-10-07.