Low GI Diet in Children and Adolescents With ALL

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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Acute lymphoblastic leukemia (ALL) is the most common childhood malignancy with survival exceeding 90%. However, treatment-related toxicity remains a clinical challenge during and after treatment. Evidence-based, nutritional interventions may minimize the development of nutrition-related toxicities, such as bone morbidities, hypertriglyceridemia, and obesity. To date, no effective interventions are available to prevent nutrition-related morbidities in children with ALL. Clinical studies evaluating the glycemic indices in other pediatric conditions have been encouraging. It is plausible that reducing the glycemic indices of diets during cancer treatment may have a profound clinical effect in this vulnerable pediatric population. Prior to the design and implementation of randomized, controlled trials, epidemiological data describing the Glycemic Index (GI) and Glycemic Load (GL) and the association with clinically important outcomes is needed. Additionally, the feasibility of a dietary intervention must also be explored within the setting of pediatric cancer. This study aims to determine the feasibility, measured by compliance to a low-GI diet, of a 6-month low glycemic dietary intervention in children and adolescents undergoing treatment for ALL. The proposed work will be used for the design and implementation of a multi-center nutritional intervention aimed at improving dietary intake during treatment and its effect on clinically important outcomes. Importantly, the information will be used to drive the formation of evidence-based nutritional guidelines for children with cancer, which will expand into the emerging field of individualized medicine for patients with cancer.

Conditions

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Acute Lymphoblastic Leukemia, Pediatric Obesity, Pediatric

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Low Glycemic Index Diet

Following a low glycemic index diet verses a standard american diet.

Group Type OTHER

Low Glycemic Index Diet

Intervention Type 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.

Interventions

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Low Glycemic Index Diet

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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