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

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT05963971
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
5 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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).

Key Dates

Start date
Mar 19, 2024
Status verified
Oct 2025
Primary completion
Dec 23, 2026
Completion
Jun 23, 2027

Study Design

Enrollment
376 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: PEDALL
    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.
  • Active Comparator: Standard of Care (SOC)
    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.

Primary Outcome Measure

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. [ Time Frame: 3.5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Medical CenterNew YorkNew York10032
Pooja Vyas, MPH
[email protected]
212-305-2631
Elena Ladas, PhD, RD
[email protected]
212-305-7835
Elena Ladas, PhD, RD (PRINCIPAL_INVESTIGATOR)
Justine Kahn, MD (SUB_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Leukemia (other)Obesity / overweight
By specialty
OncologyBlood cancerEndocrinologyMetabolic healthWeight loss
By research site
Columbia University Medical Center· New York, NY

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