Clinical trial

A Bilingual Virtually-based Intervention (PEDALL) for the Prevention of Weight Gain in Childhood ALL Patients Considering Key Genetic and Sociodemographic Risk Factors

Recruiting now · Not applicable · 1 countries · Registry ID NCT05963971

Recruiting nowNot applicableInterventional

What this study is about

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).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age5 Years to 21 Years

SexAll

Healthy volunteersNot accepted

ConditionAcute Lymphoblastic Leukemia, Obesity

Full registry 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

Treatments and study arms

PEDALL

Behavioral

Twenty-six hour nutrition education intervention delivered virtually over a six month period

Standard of care

Other

Nutrition education per institutional standard of care

Primary outcomes

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.3.5 years

Number of participants with overweight or obesity as assessed by body mass index (BMI) for age z-scores \>1 will change from baseline following 6 month virtual diet education intervention. BMI z-score will be evaluated at the end of 6-month intervention in the maintenance phase of ALL therapy. BMI z-scores will be classified by comparing age, sex, height and weight to CDC growth charts. OW is defined as BMI z-score ≥ +1.04 , and OB is defined as BMI z-score ≥ +1.645 . For participants ≥20 years of age, adult classifications will be used to determine weight status as recommended by the CDC and include BMI \< 19 underweight; BMI 19-\<25 healthy weight; BMI ≥ 25 - \<30 overweight; BMI ≥ 30 obese.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Columbia University Medical Center🇺🇸 New York, New York, United States

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Pooja Vyas, MPHContact

Email · Call 212-305-2631

Elena Ladas, PhD, RDContact

Email · Call 212-305-7835

Elena Ladas, PhD, RDPrincipal Investigator