Low GI Diet in Children and Adolescents With ALL
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ClinicalTrials.gov Identifier: NCT03157323 |
Recruitment Status : Unknown
Verified June 2019 by Elena Ladas, Columbia University.
Recruitment status was: Recruiting
First Posted : May 17, 2017
Last Update Posted : June 12, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Lymphoblastic Leukemia, Pediatric Obesity, Pediatric | Behavioral: Low Glycemic Index Diet | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Implementing a Low Glycemic Diet in Children and Adolescents Undergoing Treatment for Acute Lymphoblastic Leukemia |
Actual Study Start Date : | June 1, 2017 |
Estimated Primary Completion Date : | June 2020 |
Estimated Study Completion Date : | June 2020 |

Arm | Intervention/treatment |
---|---|
Low Glycemic Index Diet
Following a low glycemic index diet verses a standard american diet.
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Behavioral: 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. |
- Feasibility of a 6-month low glycemic dietary intervention in children and adolescents undergoing treatment for ALL. [ Time Frame: 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.

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Ages Eligible for Study: | 5 Years to 21 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03157323
Contact: Michelle Walters, MS, RD | 6463172080 | mw3328@cumc.columbia.edu | |
Contact: Elena Ladas, PhD | 2123057835 | ejd14@cumc.columbia.edu |
United States, Connecticut | |
Connecticut Children's Medical Center | Recruiting |
Hartford, Connecticut, United States, 06106 | |
Contact: Andrea Orsey, MD | |
United States, District of Columbia | |
Children's National Hospital | Recruiting |
Washington, District of Columbia, United States, 20010 | |
Contact: Jacobs Shana, MD | |
United States, New York | |
Roswell Park Cancer Institute | Recruiting |
Buffalo, New York, United States, 14263 | |
Contact: Kara Kelly, MD | |
Columbia University | Recruiting |
New York, New York, United States, 10032 | |
Contact: Michelle Walters, MS, RD | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Tracey Jubelirer, MD |
Principal Investigator: | Elena Ladas, PhD | Columbia University |
Responsible Party: | Elena Ladas, Assistant Professor of Nutrition in Pediatrics and in the Institute of Human Nutrition, Columbia University |
ClinicalTrials.gov Identifier: | NCT03157323 |
Other Study ID Numbers: |
AAAQ9790 |
First Posted: | May 17, 2017 Key Record Dates |
Last Update Posted: | June 12, 2019 |
Last Verified: | June 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Glycemic Index Acute Lymphoblastic Leukemia Dietary Change Pediatric Oncology |
Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Pediatric Obesity Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Obesity Overnutrition Nutrition Disorders Overweight Body Weight |