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Low GI Diet in Children and Adolescents With ALL

Primary Purpose

Acute Lymphoblastic Leukemia, Pediatric, Obesity, Pediatric

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low Glycemic Index Diet
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Lymphoblastic Leukemia, Pediatric focused on measuring Glycemic Index, Acute Lymphoblastic Leukemia, Dietary Change, Pediatric Oncology

Eligibility Criteria

5 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Connecticut Children's Medical CenterRecruiting
  • Children's National HospitalRecruiting
  • Roswell Park Cancer InstituteRecruiting
  • Columbia UniversityRecruiting
  • Children's Hospital of PhiladelphiaRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Low Glycemic Index Diet

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 6, 2017
Last Updated
June 10, 2019
Sponsor
Columbia University
Collaborators
American Cancer Society, Inc., Gabrielle's Angel Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03157323
Brief Title
Low GI Diet in Children and Adolescents With ALL
Official Title
Implementing a Low Glycemic Diet in Children and Adolescents Undergoing Treatment for Acute Lymphoblastic Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
American Cancer Society, Inc., Gabrielle's Angel Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia, Pediatric, Obesity, Pediatric
Keywords
Glycemic Index, Acute Lymphoblastic Leukemia, Dietary Change, Pediatric Oncology

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low Glycemic Index Diet
Arm Type
Other
Arm Description
Following a low glycemic index diet verses a standard american diet.
Intervention Type
Behavioral
Intervention Name(s)
Low Glycemic Index Diet
Intervention Description
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 Outcome Measure Information:
Title
Feasibility of a 6-month low glycemic dietary intervention in children and adolescents undergoing treatment for ALL.
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Walters, MS, RD
Phone
6463172080
Email
mw3328@cumc.columbia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Elena Ladas, PhD
Phone
2123057835
Email
ejd14@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena Ladas, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Connecticut Children's Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Orsey, MD
Facility Name
Children's National Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacobs Shana, MD
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kara Kelly, MD
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Walters, MS, RD
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tracey Jubelirer, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33590674
Citation
Walters M, Mowbray C, Jubelirer T, Jacobs S, Kelly KM, Smith K, Yao Y, Jin Z, Ladas EJ. A bilingual dietary intervention early in treatment is feasible and prevents weight gain in childhood acute lymphoblastic leukemia. Pediatr Blood Cancer. 2021 May;68(5):e28910. doi: 10.1002/pbc.28910. Epub 2021 Feb 15.
Results Reference
derived

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Low GI Diet in Children and Adolescents With ALL

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