TrialGlobe

Clinical trial

Low GI Diet in Children and Adolescents With ALL

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT03157323

Active, not recruitingNot applicableInterventional

What this study is about

The study aims to determine the feasibility of a 6-month low glycemic dietary intervention in children and adolescents undergoing treatment for acute lymphoblastic leukemia.

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, Pediatric, Obesity, Pediatric

Full registry criteria

Inclusion Criteria: * Diagnosis of Acute Lymphoblastic Leukemia (B-Cell, T-Cell, or Mixed Phenotype) * Within 3 days of starting the induction phase of treatment for Acute Lymphoblastic Leukemia * Proficient in English or Spanish Exclusion Criteria: * Diagnosis of relapsed Acute Lymphoblastic Leukemia * Not meeting all of the inclusion criteria

Treatments and study arms

Low Glycemic Index Diet

Behavioral

The nutritional intervention is theory-based and will provide nutritional education and counseling to children and their families. Nutritional counseling will be provided by the institutional designate and will focus on increasing patients' understanding of the benefits of a low GI diet, increase knowledge of low GI diet, overcoming barriers, and establishing expectations of the diet.

Primary outcomes

Feasibility of a 6-month low glycemic dietary intervention in children and adolescents undergoing treatment for ALL.6 months

Feasibility will be measured by compliance to a low glycemic index diet, which will be measured via 24 dietary recall, using the Automated Self-Administered 24-Hour Dietary Assessment Tool. A dietary recall will be taken at 7 timepoints from diagnosis to end of treatment; each recall will be defined categorically as high compliance (GI score \<55), moderate compliance (GI score 56-69) and low compliance (GI score \>70). Change in glycemic index score will show compliance.

Study locations

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

Roswell Park Cancer Institute🇺🇸 Buffalo, New York, United States
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Connecticut Children's Medical Center🇺🇸 Hartford, Connecticut, United States
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Columbia University🇺🇸 New York, New York, United States
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Children's Hospital of Philadelphia🇺🇸 Philadelphia, Pennsylvania, United States
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Children's National Hospital🇺🇸 Washington D.C., District of Columbia, United States
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