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

NCT05963971 | Recruiting DMC

• 2 other identifiers: AAAU5938W81XWH2210452
• Study Type: interventional
• Target: 376
• Locations: 1 country
• Sites: 1

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

Keywords

Acute Lymphoblastic Leukemia; Obesity; Childhood Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Number of participants with overweight or obesity as assessed by body mass index (BMI) for age z-scores \>1 will change from baseline following 6 month virtual diet education intervention. BMI z-score will be evaluated at the end of 6-month intervention in the maintenance phase of ALL therapy. BMI z-scores will be classified by comparing age, sex, height and weight to CDC growth charts. OW is defined as BMI z-score ≥ +1.04 , and OB is defined as BMI z-score ≥ +1.645 . For participants ≥20 years of age, adult classifications will be used to determine weight status as recommended by the CDC and include BMI \< 19 underweight; BMI 19-\<25 healthy weight; BMI ≥ 25 - \<30 overweight; BMI ≥ 30 obese.

  3.5 years

Secondary Outcomes (6)

• The effect of intervention on BMI z-score trajectories over time (from time zero to one-year post-completion of treatment for ALL) and modification of this effect by genetic and sociodemographic factors.

  4 years

• The modifying effect of genetic predisposition to OW/OB, defined by a genome-wide polygenic score (GPS) for obesity optimized for Hispanic and Non-Hispanic application, on the efficacy of PEDALL intervention

  4 years

• The modifying effect of multi-level sociodemographic factors on the efficacy of PEDALL for the prevention of OW/OB in children and adolescents undergoing treatment for ALL.

  4 years

• The effect of intervention on reported lifestyle behaviors as measured by World Cancer Research Foundation/American Institute for Cancer Research lifestyle guidelines.

  4 years

• Understand contextual factors that shaped the recruitment and retainment of participants and to identify strategies that may hinder or support implementation within routine care at sites

  4 years

Study Arms (2)

PEDALL

EXPERIMENTAL

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.

Behavioral: PEDALL

Standard of Care (SOC)

ACTIVE COMPARATOR

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.

Other: Standard of care

Interventions

PEDALL BEHAVIORAL

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

PEDALL

Standard of care OTHER

Nutrition education per institutional standard of care

Standard of Care (SOC)

Eligibility Criteria

• Age: 5 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patients on nutrition support (enteral or parenteral nutrition)
• Patients with a history of eating disorder

Sponsors & Collaborators

• Columbia University: lead
• United States Department of Defense: collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Obesity; Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Elena Ladas, PhD, RD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pooja Vyas, MPH

CONTACT

2123052631; psv2103@cumc.columbia.edu

Elena J. Ladas, PhD, RD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants who are randomized to the intervention group will receive the same virtually-delivered nutrition educational intervention.

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: July 27, 2023
• Study Start: March 19, 2024
• Primary Completion (Estimated): December 23, 2026
• Study Completion (Estimated): June 23, 2027
• Last Updated: October 7, 2025

Record last verified: 2025-10

Locations

US (1)