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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
No Placebo-Only Group
Summary
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.
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3.5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Dietary education interventions, such as those studied in the PEDALL trial, work by promoting healthy eating habits and increasing awareness of nutritional choices. These interventions typically focus on reducing the intake of high-calorie, low-nutrient foods while encouraging the consumption of fruits, vegetables, whole grains, and lean proteins.
By educating patients on portion control, meal planning, and the importance of balanced nutrition, these programs aim to create sustainable lifestyle changes that can prevent weight gain and promote weight loss. This approach is crucial for obesity patients as it addresses the root causes of obesity, helps improve overall health, and reduces the risk of obesity-related complications such as diabetes, hypertension, and cardiovascular diseases.
Effectiveness of interventions to improve lifestyle behaviors among socially disadvantaged children in Europe.Improving diet and physical activity to reduce population prevalence of overweight and obesity: an overview of current evidence.
Effectiveness of interventions to improve lifestyle behaviors among socially disadvantaged children in Europe.Improving diet and physical activity to reduce population prevalence of overweight and obesity: an overview of current evidence.
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Who is running the clinical trial?
United States Department of DefenseFED
901 Previous Clinical Trials
332,589 Total Patients Enrolled
5 Trials studying Obesity
955 Patients Enrolled for Obesity
Columbia UniversityLead Sponsor
1,482 Previous Clinical Trials
2,629,575 Total Patients Enrolled
43 Trials studying Obesity
5,709 Patients Enrolled for Obesity
Elena Ladas, PhD, RDPrincipal InvestigatorColumbia University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am undergoing or planning to undergo maintenance chemotherapy for acute lymphoblastic leukemia.I am receiving nutrition through a feeding tube or IV.I can start the study treatment within the first month of my maintenance therapy for ALL.I am between 5 and 21 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care (SOC)
- Group 2: PEDALL
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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