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Trial Title:
A Bilingual Virtually-based Intervention (PEDALL) for the Prevention of Weight Gain in Childhood ALL Patients Considering Key Genetic and Sociodemographic Risk Factors
NCT ID:
NCT05963971
Condition:
Acute Lymphoblastic Leukemia
Obesity
Conditions: Official terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Weight Gain
Conditions: Keywords:
Acute Lymphoblastic Leukemia
Obesity
Childhood Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
All participants who are randomized to the intervention group will receive the same
virtually-delivered nutrition educational intervention.
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
PEDALL
Description:
twenty-six hour nutrition education intervention delivered virtually over a six month
period
Arm group label:
PEDALL
Intervention type:
Other
Intervention name:
Standard of care
Description:
Nutrition education per institutional standard of care
Arm group label:
Standard of Care (SOC)
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).
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
5 Years
Maximum age:
21 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Columbia University Medical Center
Address:
City:
New York
Zip:
10032
Country:
United States
Status:
Recruiting
Contact:
Last name:
Pooja Vyas, MPH
Phone:
212-305-2631
Email:
psv2103@cumc.columbia.edu
Contact backup:
Last name:
Elena Ladas, PhD, RD
Phone:
212-305-7835
Email:
ejd14@cumc.columbia.edu
Investigator:
Last name:
Elena Ladas, PhD, RD
Email:
Principal Investigator
Investigator:
Last name:
Justine Kahn, MD
Email:
Sub-Investigator
Start date:
March 19, 2024
Completion date:
June 23, 2027
Lead sponsor:
Agency:
Columbia University
Agency class:
Other
Collaborator:
Agency:
United States Department of Defense
Agency class:
U.S. Fed
Source:
Columbia University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05963971
