NCT03157323

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Jun 2017Jun 2026

First Submitted

Initial submission to the registry

April 6, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 17, 2017

Completed
15 days until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

February 18, 2025

Status Verified

February 1, 2025

Enrollment Period

6 years

First QC Date

April 6, 2017

Last Update Submit

February 14, 2025

Conditions

Acute Lymphoblastic Leukemia, PediatricObesity, Pediatric

Keywords

Glycemic IndexAcute Lymphoblastic LeukemiaDietary ChangePediatric Oncology

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Study Arms (1)

Low Glycemic Index Diet

OTHER

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

Behavioral: Low Glycemic Index Diet

Interventions

Low Glycemic Index DietBEHAVIORAL

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.

Low Glycemic Index Diet

Eligibility Criteria

Age5 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Diagnosis of relapsed Acute Lymphoblastic Leukemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • 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.

    PMID: 33590674DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaPediatric Obesity

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Elena Ladas, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2017

First Posted

May 17, 2017

Study Start

June 1, 2017

Primary Completion

June 1, 2023

Study Completion (Estimated)

June 1, 2026

Last Updated

February 18, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

US(5)