PEDALL Program for Childhood Acute Lymphoblastic Leukemia Weight Management
(PEDALL Trial)
Recruiting in Palo Alto (17 mi)
Overseen byElena Ladas, PhD, RD
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Columbia University
Disqualifiers: Nutrition support, Eating disorder, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
This trial tests an online nutrition education program called PEDALL for children and teens with acute lymphoblastic leukemia (ALL) who are undergoing maintenance chemotherapy. The goal is to prevent them from becoming overweight or obese, which is a common issue during treatment. By teaching healthy eating habits and providing regular support, the program aims to help these young patients maintain a healthy weight.
Will I have to stop taking my current medications?
The trial does not specify whether you need to stop taking your current medications. It focuses on dietary education during chemotherapy, so it's best to discuss your medications with the trial team.
What data supports the effectiveness of the PEDALL treatment for weight management in children with acute lymphoblastic leukemia?
Research shows that lifestyle interventions, including exercise and dietary changes, can help manage weight in children with acute lymphoblastic leukemia. A study found that a 12-week lifestyle program helped children improve their diet, suggesting that similar interventions like PEDALL could be effective in preventing weight gain.12345
Is the PEDALL Program for Childhood Acute Lymphoblastic Leukemia Weight Management safe for children?
How is the PEDALL treatment different from other treatments for childhood acute lymphoblastic leukemia?
The PEDALL treatment is unique because it focuses on preventing weight gain in children with acute lymphoblastic leukemia through a bilingual, virtually-based lifestyle intervention, which includes web-based sessions and phone calls with a lifestyle coach. This approach is different from traditional treatments that primarily focus on medical interventions, as it emphasizes early lifestyle changes to manage weight and improve long-term health outcomes.123910
Eligibility Criteria
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.Inclusion Criteria
I am undergoing or planning to undergo maintenance chemotherapy for acute lymphoblastic leukemia.
Ethnicity: Hispanic or Non-Hispanic of any race
I can start the study treatment within the first month of my maintenance therapy for ALL.
See 3 more
Exclusion Criteria
I am receiving nutrition through a feeding tube or IV.
Patients with a history of eating disorder
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive a six-month virtually-delivered dietary education intervention (PEDALL) during maintenance chemotherapy
6 months
26 virtual visits (once weekly)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including BMI z-score trajectories over time
1 year post-treatment
Treatment Details
Interventions
- PEDALL (Behavioral Intervention)
Trial OverviewThe 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.
Participant Groups
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Columbia University Medical CenterNew York, NY
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Who Is Running the Clinical Trial?
Columbia UniversityLead Sponsor
United States Department of DefenseCollaborator
References
Feasibility and initial effectiveness of home exercise during maintenance therapy for childhood acute lymphoblastic leukemia. [2022]Children with acute lymphoblastic leukemia (ALL) are at increased risk of obesity and deconditioning from cancer therapy. This pilot study assessed feasibility/initial efficacy of an exercise intervention for patients with ALL undergoing maintenance therapy.
Early Lifestyle Intervention for Obesity Prevention in Pediatric Survivors of Acute Lymphoblastic Leukemia. [2020]Patients with pediatric acute lymphoblastic leukemia (ALL) experience rapid weight gain during treatment and increases in weight are maintained throughout treatment and beyond. Without prompt interventions, altered dietary and physical activity behaviors may become difficult to reverse, contributing to obesity risk long-term. Fifteen children, aged 3-9 years, diagnosed with pediatric ALL who were on maintenance therapy or within two years of treatment completion (mean BMI percentile: 70.4th) and one parent from each family, were enrolled into a 12-week lifestyle intervention delivered remotely through web-based sessions and phone calls with a lifestyle coach. Outcomes were assessed at baseline and end of the intervention. Thirteen of the 15 enrolled families (86.7%) completed the intervention. Parents reduced the "pressure to eat" feeding practice (change in mean score: -0.60, 95% CI: -1.12 to -0.07; p-value = 0.03) post intervention. Children increased the consumption of milk (0.54 serving/d, 0.02 to 1.07; p-value = 0.04) and percent of calories from protein (2.54%, 0.22 to 4.87%; p-value = 0.04) and reduced the consumption of potatoes (-0.16 serving/d, -0.30 to -0.03; p-value = 0.02). No significant changes were observed for children's levels of physical activity, BMI, or waist circumference. Results from this pilot support the feasibility and preliminary efficacy of early lifestyle intervention among pediatric ALL survivors.
Exercise program for children and adolescents with leukemia and lymphoma during treatment: A comprehensive review. [2019]An exercise program (EP) during cancer treatment seems to be a valid strategy against physiological and quality-of-life impairments, but scientific evidence of benefits among pediatric patients is still limited. This review summarizes the literature focused on randomized controlled trials of EP offered to patients during leukemia and lymphoma treatment. Studies published up to June 2017 were selected from multiple databases and assessed by three independent reviewers for methodological validity. The review identified eight studies, but several types of bias have to be avoided to provide evidence-based recommendations accessible to patients, families, and professionals.
Therapy-related changes in body size in Hispanic children with acute lymphoblastic leukemia. [2021]The objective of this study was to examine changes over time in body mass index (BMI) from diagnosis through chemotherapy for pediatric patients with B-precursor acute lymphoblastic leukemia (ALL).
Overweight in childhood cancer patients at diagnosis and throughout therapy: A multicentre cohort study. [2020]Childhood cancer patients (CCP) have been reported to be at increased risk of becoming overweight during treatment. We assessed prevalence of overweight in CCP at diagnosis and at the end of treatment, determined risk factors, and identified weight change during treatment by type of cancer.
Exercise interventions for patients with pediatric cancer during inpatient acute care: A systematic review of literature. [2022]Physical inactivity has been shown to exacerbate negative side effects experienced by pediatric patients undergoing cancer therapy. Exercise interventions are being created in response. This review summarizes current exercise intervention data in the inpatient pediatric oncology setting. Two independent reviewers collected literature from three databases, and analyzed data following the PRISMA statement for systematic reviews and meta-analyses. Ten studies were included, representing 204 patients. Good adherence, positive trends in health status, and no adverse events were noted. Common strategies included individual, supervised, combination training with adaptability to meet fluctuating patient abilities. We recommend that general physical activity programming be offered to pediatric oncology inpatients.
The effect of oral nutrition supplements and appetite stimulants on weight status among pediatric cancer patients: A systematic review. [2023]The objective of this study was to identify the use and impact of oral nutrition supplements (ONSs) and appetite stimulants on weight status among pediatric patients diagnosed with malignancy. We performed a literature search of trials using Medline PubMed, CINAHL, Web of Science Core Collection, Scopus, and Cochrane Database of Systematic Reviews and included all prospective studies except review articles and case-reports/series that assessed ONSs or appetite stimulants among patients (0-20 years old) diagnosed with a pediatric malignancy. Databases were searched through May 17, 2022. There were six trials included with three studies related to ONS and the remaining on appetite stimulants. No studies that compared both ONS and appetite stimulants were found. To assess quality, we used the Risk of Bias in Nonrandomized Studies of Interventions and the Revised Cochrane Risk of Bias Tool for Randomized Trials depending on the study design. The studies all had pediatric patients diagnosed with a variety of malignancy types. All studies demonstrated improvement of weight status in the treatment group across various malignancy types. However, none of the studies addressed nutrition intakes outside of ONS consumption, compliance to ONSs, or frequency of ONS use. Despite the short durations (3-6 months) and significant differences in the timing of intervention initiation (ONS or appetite stimulants), these treatment modalities can improve weight status. Further research is needed to identify the best intervention for improving weight status.
Clinical field testing of an enhanced-activity intervention in hospitalized children with cancer. [2007]This prospective, two-site, randomized, controlled pilot study assessed the feasibility of an enhanced physical activity (EPA) intervention in hospitalized children and adolescents receiving treatment for a solid tumor or for acute myeloid leukemia (AML), and assessed different statistical techniques to detect the intervention's sleep and fatigue outcomes. Twenty-nine patients (25 with a solid tumor and 4 with AML) participated. Data were collected from actigraph; patient, parent, and staff nurse reports of patient fatigue; parent sleep diaries; and patient charts. The intervention was successfully implemented 85.4% of the scheduled times. We used two different statistical methods to analyze the longitudinal data. Using an ANOVA model, sleep was significantly more efficient in the experimental arm than in the control arm when daily differences from baseline sleep efficiency values were averaged and compared (F=4.17, P=0.053). However, in a mixed model (repeated measures) analysis, sleep duration (F=0.54, P=0.47) and sleep efficiency (F=0.04, P=0.85) were not seen to differ between study arms. We conclude that an inpatient intervention of EPA can be delivered to children and adolescents receiving chemotherapy. Our findings identify design and statistical considerations for a future effectiveness study of the EPA intervention in hospitalized pediatric oncology patients.
Malnutrition screening and treatment in pediatric oncology: a scoping review. [2022]Malnutrition and cachexia during pediatric cancer treatment worsen toxicity and quality-of-life. Clinical practice varies with lack of standard malnutrition definition and nutrition interventions. This scoping review highlights available malnutrition screening and intervention data in childhood cancer and the need for standardizing assessment and treatment.
The effect of an aerobic exercise program on the quality of life in children with cancer. [2019]Khodashenas E, Badiee Z, Sohrabi M, Ghassemi A, Hosseinzade V. The effect of an aerobic exercise program on the quality of life in children with cancer. Turk J Pediatr 2017; 59: 678-683. Aerobic exercise such as physical activity plays an essential role for a healthy development for children undergoing chemotherapy and radiation therapy. The aim of this study was to examine the effectiveness of an aerobic exercise program on quality of life in children undergoing cancer treatment. Patients diagnosed with acute lymphoblastic leukemia (ALL), undergoing chemotherapy, were divided into two groups; the control group received the routine treatment with activities of daily living and the interventional group received routine treatment in addition to an aerobic exercise program. Data was collected using the pediatric quality of life questionnaires (PedsQL version 4) before and after the training program. We enrolled 20 cancer patients, who were referred to Dr. Sheikh Children`s Hospital in Mashhad, Iran; 8 (40%) and 12 (60%) of the patients were female and male, respectively. The results show a significant association in the pain and injury subscale (p=0.002), improving in interventional groups after test compared to the control groups. The reports of parents of the children`s quality of life showed significant association in the pain and injury subscale (P=0.002), and cognitive problems subscale at school (P=0.039). The regular exercise and psychosocial program intervention can improve wellbeing and thereby enhance efficacy of the children during treatment.