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ALL-Active: A Family-Based Lifestyle Program for Pediatric Acute Leukemia Patients

NCT01901367 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2018-05-08

No results posted yet for this study

Summary

This randomized pilot phase II trial studies how well nutritional intervention and exercise intervention works in preventing metabolic syndrome in younger patients with acute lymphoblastic leukemia. Nutritional intervention may help weight loss and improve quality of life in patients with acute lymphoblastic leukemia. Exercise may help decrease feelings of being tired caused by cancer, may help improve strength, and may help build up lost muscle tissue. Nutritional intervention plus exercise intervention may be effective at preventing metabolic syndrome.

Conditions

  • Childhood Acute Lymphoblastic Leukemia in Remission

Interventions

DIETARY_SUPPLEMENT

nutritional intervention

Receive nutritional intervention

BEHAVIORAL

exercise intervention

Receive exercise intervention

OTHER

follow-up care

Receive booster follow-up sessions from the nutritionist and exercise physiologist

BEHAVIORAL

counseling intervention

Receive phone counseling with a trained health coach

OTHER

quality-of-life assessment

Ancillary studies

OTHER

laboratory biomarker analysis

Correlative studies

OTHER

questionnaire administration

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Vanderbilt-Ingram Cancer Center

    lead OTHER

Principal Investigators

  • Adam Esbenshade, MD · Vanderbilt-Ingram Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2014-09-30
Completion
2015-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01901367 on ClinicalTrials.gov