Acute Lymphoblastic LeukemiaPEDALLNCT05963971
A Bilingual Virtually-based Intervention (PEDALL) for the Prevention of Weight Gain in Childhood ALL Patients Considering Key Genetic and Sociodemographic Risk Factors
A study testing PEDALL in people with Acute Lymphoblastic Leukemia and Obesity, run by Columbia University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 5 to 21 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Obesity
- What is being tested?
- PEDALL
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 376 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2024to 23 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Patients on nutrition support (enteral or parenteral nutrition)
- Patients with a history of eating disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Medical Center
New York, New York, 10032
Pooja Vyas, MPH, 212-305-2631, psv2103@cumc.columbia.edu
Elena Ladas, PhD, RD, 212-305-7835, ejd14@cumc.columbia.edu
About this study
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).
Read the detailed description
Acute lymphoblastic leukemia (ALL) has been referred to as a "pre-obese state", with many studies describing the onset of obesity during treatment. Weight gain typically begins within the first month of ALL diagnosis, stabilizes, and then resumes at the beginning of maintenance and continues into survivorship. Children and adolescents with healthy weight at diagnosis are the most vulnerable to weight gain; up to 70% develop overweight/obesity (OW/OB) by the end of treatment (EOT). Weight gain during treatment is one of the most consistently reported risk factors for weight gain in survivorship and is associated with an increased odds of being OW/OB 5-years post-EOT. Significant clinical ramifications are associated with being OW/OB. A meta-analysis led by the Children's Oncology Group nutrition committee found that OW/OB is associated with a 31% increased risk of mortality in ALL.
The objective of the study team is 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. Once enrolled, subjects will be randomized to PEDALL or standard of care (SOC). Subjects in the PEDALL group will receive 26 contact hours of specialized nutrition education and counseling via a virtual platform.
The purpose of this study is to determine the effectiveness of a virtually-delivered dietary education intervention in the prevention of OW/OB compared to SOC during maintenance chemotherapy. The clinical impact of this study will improve the understanding of pre-treatment factors predictive of the efficacy of intervention to prevent unhealthy weight gain among patients treated for ALL. Study findings may lead to the allocation of limited clinical resources to individuals most susceptible to OW/OB. Information obtained from this study may also direct the refinement of counseling techniques to enhance the likelihood of success over the course of treatment for ALL and into survivorship. The long-term goal is to enhance the likelihood of success of weight maintenance during therapy thereby mitigating excess toxicities during treatment and reducing nutrition-related late-effects associated with OW/OB among survivors of childhood ALL.
- Conditions
- Acute Lymphoblastic Leukemia, Obesity
- Being tested
- PEDALL, Standard of care
- Keywords
- Acute Lymphoblastic Leukemia, Obesity, Childhood Cancer
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Obesity, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEDALLBehavioural
Twenty-six hour nutrition education intervention delivered virtually over a six month period
Standard of careOther
Nutrition education per institutional standard of care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
The proportion of OW/OB based on BMI (measured in kilograms per meters squared) at the end of treatment (EOT) for ALL and at one-year post-EOT for ALL will be analyzed as the exploratory outcomes measure of interest. The change in outcome at EOT to 1-year post EOT using a similar analytical approach to the Primary Objective will be analyzed also.
Measured: 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
The modifying effect of GPS score will be calculated based on an algorithm optimized for trans-ethnic application both as a continuous variable and a dichotomized variable (<median value vs ≥ median value based on PEDALL cohort), on the efficacy of PEDALL for the prevention of OW/OB at EOT and at one-year post EOT, as well as the change in outcome between the two timepoints using repeated measure ANOVA and generalized estimating equation (GEE) modeling.
Measured: 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.
Multi-level modeling will be used to examine the modifying effect of variables known to influence dietary behaviors on the efficacy of PEDALL for the prevention of the primary outcome. Social demographic variables to be considered for this objective are self-reported race (white vs other) and ethnicity (Hispanic vs non-Hispanic), foreign-born status (yes/no), food security (0-1 high or marginal food security vs 2-4 low food security vs 5-6 very low food security), and home food environments measured at study entry using a social demographic survey.
Measured: 4 years
The effect of intervention on reported lifestyle behaviors as measured by World Cancer Research Foundation/American Institute for Cancer Research lifestyle guidelines.
Data will be collected from 24 hour diet recalls and PROMIS® survey responses and dietary and lifestyle indices will be operationalized based on the WCRF/AICR recommendations. The adapted WCRF/AICR score ranges from 0-7 and is based on 7 dietary components. Participants will receive 1 point, 0.5 points, or 0 points when the recommendation is met, partially met, or not met, respectively, within each group, with a higher score indicating greater adherence. Overall adherence scores will be analyzed by comparing the distribution of scores across arms using Wilcoxon ranked sign tests and the van Elteren test to adjust for the stratification factors.
Measured: 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
Directed content analysis will be used to analyzed open-ended survey responses to code a priori domains of interest (guided by research questions and CFIR domains) and to inductively explore any emergent themes. This list will then be used to develop a coding dictionary and apply it to subset of the data. Inter-rater reliability will be measured to document and improve coding consistency. Once high reliability is achieved (kappa >0.8), the full coding dictionary will be applied to the interview data using NVivo, and produce thematic reports summarizing the findings. Qualitative data will then be used to expand upon and triangulate quantitative patterns identified in trial and structured data. Survey Data will be analyzed descriptively and coded dichotomously or categorically as appropriate.
Measured: 4 years
Understand individual factors and site-specific factors that shaped both experience with and response to the intervention using a one-time, brief open-ended questionnaire to patients and caregivers.
Directed content analysis will be used to analyzed open-ended survey responses to code a priori domains of interest (guided by research questions and CFIR domains) and to inductively explore any emergent themes. This list will then be used to develop a coding dictionary and apply it to subset of the data. Inter-rater reliability will be measured to document and improve coding consistency. Once high reliability is achieved (kappa >0.8), the full coding dictionary will be applied to the interview data using NVivo, and produce thematic reports summarizing the findings. Qualitative data will then be used to expand upon and triangulate quantitative patterns identified in trial and structured data. Survey Data will be analyzed descriptively and coded dichotomously or categorically as appropriate.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start19 Mar 2024
- Primary completion23 Dec 2026 (estimated)
- Study completion23 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All participants who are randomized to the intervention group will receive the same virtually-delivered nutrition educational intervention.
- Masking
- None (open label)
- Enrolment
- 376 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Elena Ladas, PhD, RD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963971
- Sponsor's protocol ID
- AAAU5938
- Other IDs
- W81XWH2210452
- Acronym
- PEDALL
- Status last verified
- Oct 2025
- First submitted
- 29 Jun 2023
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05963971
- Acronym / sponsor ID
- PEDALL / AAAU5938
- Conditions
- Acute Lymphoblastic Leukemia, Obesity
- Keywords
- Acute Lymphoblastic Leukemia, Obesity, Childhood Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 376 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 23 Dec 2026 (estimated)
- Study completion
- 23 Jun 2027 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Acute lymphoblastic leukemia (ALL) has been referred to as a "pre-obese state", with many studies describing the onset of obesity during treatment. Weight gain typically begins within the first month of ALL diagnosis, stabilizes, and then resumes at the beginning of maintenance and continues into survivorship. Children and adolescents with healthy weight at diagnosis are the most vulnerable to weight gain; up to 70% develop overweight/obesity (OW/OB) by the end of treatment (EOT). Weight gain during treatment is one of the most consistently reported risk factors for weight gain in survivorship and is associated with an increased odds of being OW/OB 5-years post-EOT. Significant clinical ramifications are associated with being OW/OB. A meta-analysis led by the Children's Oncology Group nutrition committee found that OW/OB is associated with a 31% increased risk of mortality in ALL.
The objective of the study team is 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. Once enrolled, subjects will be randomized to PEDALL or standard of care (SOC). Subjects in the PEDALL group will receive 26 contact hours of specialized nutrition education and counseling via a virtual platform.
The purpose of this study is to determine the effectiveness of a virtually-delivered dietary education intervention in the prevention of OW/OB compared to SOC during maintenance chemotherapy. The clinical impact of this study will improve the understanding of pre-treatment factors predictive of the efficacy of intervention to prevent unhealthy weight gain among patients treated for ALL. Study findings may lead to the allocation of limited clinical resources to individuals most susceptible to OW/OB. Information obtained from this study may also direct the refinement of counseling techniques to enhance the likelihood of success over the course of treatment for ALL and into survivorship. The long-term goal is to enhance the likelihood of success of weight maintenance during therapy thereby mitigating excess toxicities during treatment and reducing nutrition-related late-effects associated with OW/OB among survivors of childhood ALL.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All participants who are randomized to the intervention group will receive the same virtually-delivered nutrition educational intervention.
| Arm | Type | Receives |
|---|---|---|
| PEDALL | Experimental | Behavioral: PEDALLThe 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. |
| Standard of Care (SOC) | Active comparator | Other: Standard of careSubjects 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. |
Who may qualify
- Ages
- 5 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients on nutrition support (enteral or parenteral nutrition)
- Patients with a history of eating disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEDALLTwenty-six hour nutrition education intervention delivered virtually over a six month period | Behavioural | PEDALL |
| Standard of careNutrition education per institutional standard of care | Other | Standard of Care (SOC) |
Primary outcome
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
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.
6 secondary outcomes
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.
Time frame: 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
Time frame: 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.
Time frame: 4 years
The effect of intervention on reported lifestyle behaviors as measured by World Cancer Research Foundation/American Institute for Cancer Research lifestyle guidelines.
Time frame: 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
Time frame: 4 years
Understand individual factors and site-specific factors that shaped both experience with and response to the intervention using a one-time, brief open-ended questionnaire to patients and caregivers.
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elena Ladas, PhD, RD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEDALL in people with Acute Lymphoblastic Leukemia and Obesity, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pooja Vyas, MPH (2123052631, psv2103@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.