What side effects are associated with this type of intervention?

Common treatments for obesity, particularly dietary and lifestyle interventions like those in the PEDALL trial, generally have minimal side effects. These interventions focus on promoting healthy eating habits, increasing physical activity, and behavioral modifications. Potential side effects may include temporary gastrointestinal discomfort, such as bloating or constipation, as the body adjusts to a new diet. In contrast, pharmacological treatments can have more significant side effects, including increased heart rate, insomnia, and gastrointestinal issues, while surgical options may involve risks such as infections, nutrient deficiencies, and complications from anesthesia.

What prior FDA approvals exist?

The FDA has approved several pharmacological treatments for obesity that complement dietary and lifestyle interventions. Notable examples include GLP-1 receptor agonists like liraglutide and semaglutide, which aid in weight loss by promoting satiety and reducing appetite. Additionally, combination drugs such as phentermine-topiramate and bupropion-naltrexone have been approved for their efficacy in weight management. These treatments are often recommended alongside comprehensive dietary education and lifestyle modifications, similar to the approach taken in the PEDALL trial, which emphasizes healthy eating habits to prevent overweight and obesity.

What other types of research exist?

Promising alternatives to PEDALL for obesity patients include: 1) The Staged Transitional Eating Plan (STEP), which is a ketogenic diet option designed for patients unresponsive to standard dietary changes. 2) Bariatric procedures such as Roux-en-Y gastric bypass and laparoscopic gastric bypass, which have shown long-term efficacy in weight loss and obesity management. 3) Pharmacological treatments like GLP-1 agonists and SGLT2 inhibitors, which are associated with moderate weight loss and can be considered for patients with obesity and type 2 diabetes.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3.5 years for reporting.

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 more

Awards & 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.

Do I qualify?Apply below to find out

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.