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Preventing Weight Gain in Children with ALL: The PEDALL Study

This study is testing an intervention called PEDALL, a six-month nutrition education program delivered online, to help prevent children and adolescents with acute lymphoblastic leukemia (ALL) from becoming overweight or obese during their maintenance chemotherapy. Many children with ALL gain weight during treatment, which can lead to health problems later. The PEDALL program, offered in English and Spanish, aims to teach families about healthy eating. You could be eligible if you are 5 to 21 years old, are receiving or will receive maintenance chemotherapy for ALL, and can start the program within the first month of this treatment phase. The study will measure if PEDALL is more effective than standard nutrition care at preventing overweight or obesity over 3.5 years.

Study design
This interventional study plans to enroll 376 participants. Participants will be randomly assigned to either receive the PEDALL intervention or standard nutrition education.
What's involved
If you are in the PEDALL group, you will receive 26 hours of specialized nutrition education and counseling online over six months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 3.5 years to see the long-term effects of the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05963971

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

Recruiting
NAAges 5–21InterventionalPrevention
Columbia University
~376 participants
Updated 2025-10-07 on ClinicalTrials.gov
What's tested:PEDALLStandard of care

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over 3.5 years

Conditions

Acute Lymphoblastic Leukemia
Obesity

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Acute Lymphoblastic Leukemia

NCT05963971

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Columbia University Medical Center

    New York, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

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

Who to contact

Pooja Vyas, MPH
[email protected]
2123052631
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • 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.3.5 years

    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.