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Behavioral Intervention

PEDALL Program for Childhood Acute Lymphoblastic Leukemia Weight Management (PEDALL Trial)

N/A

Recruiting

Led By Elena Ladas, PhD, RD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3.5 years

Awards & highlights

PEDALL Trial Summary

This trial will test if a 6-month nutrition education program can help prevent overweight/obesity in kids/teens on chemo for ALL.

Who is the study for?

This trial is for children and young adults aged 5-21 fluent in English or Spanish, diagnosed with B- or T-cell ALL or mixed phenotype acute leukemia. They must be starting maintenance chemotherapy, have a healthy weight (specific BMI criteria), and can be of any race. Those on nutrition support or with eating disorders cannot participate.Check my eligibility

What is being tested?

The study tests the PEDALL program—a six-month virtual dietary education—against standard care to prevent overweight and obesity during maintenance chemotherapy in young patients with acute lymphoblastic leukemia.See study design

What are the potential side effects?

Since this trial involves educational intervention rather than medication, there are no direct medical side effects. However, participants may experience changes in lifestyle habits due to new dietary practices.

PEDALL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome 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.

Secondary outcome measures

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.

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

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

+3 more

PEDALL Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PEDALLExperimental Treatment1 Intervention

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.

Group II: Standard of Care (SOC)Active Control1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,433 Previous Clinical Trials

2,446,883 Total Patients Enrolled

40 Trials studying Obesity

5,618 Patients Enrolled for Obesity

Elena Ladas, PhD, RDPrincipal InvestigatorColumbia University

Media Library

PEDALL (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05963971 — N/A

Obesity Research Study Groups: Standard of Care (SOC), PEDALL

Obesity Clinical Trial 2023: PEDALL Highlights & Side Effects. Trial Name: NCT05963971 — N/A

PEDALL (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05963971 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial have an age restriction, and if so, what is it?

"Those who are between 5 and 21 years old can be considered for enrolment into this clinical trial."

Answered by AI

How many individuals are projected to join this trial before its completion?

"Affirmative, the clinicaltrials.gov page for this trial indicates that recruitment is ongoing - it was posted on June 23rd 2023 and last edited on July 19th 2023. 376 participants must be enrolled from a single site."

Answered by AI

Could I become a participant in this trial?

"The parameters for inclusion in this trial necessitate that patients have acute lymphoblastic leukemia, and are aged between 5 and 21. At present, 376 participants are eligible to join the study."

Answered by AI

Is enrollment open for this experiment at present?

"According to clinicaltrials.gov, the trial is actively seeking participants and was first advertised on June 23rd 2023 with a recent update made on July 19th 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Elena Ladas 2023. "A Bilingual Virtually-based Intervention (PEDALL) for the Prevention of Weight Gain in Childhood ALL Patients Considering Key Genetic and Sociodemographic Risk Factors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05963971.

All > Weight Gain