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A Virtual Dietary Education Intervention (PEDALL) for the Prevention of Weight Gain During Maintenance Chemotherapy in Children and Adolescents with Acute Lymphoblastic Leukemia
Trial Status: active
This clinical trial evaluates a virtual dietary education intervention, Pediatric Diet Intervention for Children with Acute Lymphoblastic Leukemia (PEDALL), for the prevention of weight gain during maintenance chemotherapy in children and adolescents with acute lymphoblastic leukemia (ALL). A significant proportion of children and adolescents gain weight during treatment for childhood ALL, which can have negative effects on treatment outcomes. PEDALL may be an effective method to help people learn about healthy foods and reduce obesity-promoting foods. This may reduce weight gain and improve well-being and quality of life in children and adolescents with ALL during chemotherapy.
Inclusion Criteria
PATIENTS: 5-21 years old at enrollment
PATIENTS: Plan to receive or are receiving maintenance or continuation chemotherapy for B- or T-cell ALL, or mixed phenotype acute leukemia
PATIENTS: Patient is eligible for entry only if ±30 days of the beginning of the maintenance phase of ALL therapy
PATIENTS: Fluency in English or Spanish
PATIENTS: Healthy weight at baseline as determined by BMI z-score < 1.04 and > -1.65 for those under 5-18, and BMI between 19 and 25 for those > 18
PATIENTS: Hispanic or non-Hispanic of any race
STUDY SITE DESIGNATE: The site principal investigator/study site designate
STUDY SITE DESIGNATE: Age 18 or older
STUDY SITE DESIGNATE: Fluency in English
Exclusion Criteria
PATIENTS: Patients on nutrition support (enteral or parenteral nutrition)
PATIENTS: Patients with a history of eating disorder
STUDY SITE DESIGNATE: Unwilling to provide consent
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05963971.
I. To prevent the development of overweight and obesity (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.
EXPLORATORY OBJECTIVE:
I. To assess the effect of intervention on body mass index (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.
ANCILLARY STUDY OBJECTIVES:
I. To examine 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 for the prevention of OW/OB in children and adolescents undergoing treatment for ALL.
II. To examine 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.
III. To understand the effect of intervention on reported lifestyle behaviors as measured by World Cancer Research Foundation/American Institute for Cancer Research lifestyle guidelines.
IV. To 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 their site including resource, training and technological needs using a one-time, brief structured survey at the end of the study with study site designate.
V. To 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.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients and caregivers receive printed nutrition education materials and attend virtually-delivered educational instruction sessions with a registered dietician (RD) over 1-1.5 hours once a week (QW) for 6 months. Patients undergo blood sample collection during a routine blood draw on study.
ARM II: Patients receive printed nutrition education materials at study entry and then per standard of care. Patients also undergo blood sample collection during a routine blood draw on study.
After completion of study intervention, patients are followed up at months 9, 12, and 24.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationNYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
