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Reduce Sedentary Time in Acute Lymphoblastic Leukemia

NCT06182163 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-02-02

No results posted yet for this study

Summary

The goal of this feasibility trial is to test if a mobile health intervention, including a wearable fitness tracker with inactivity-triggered reminders to move, individualized coaching sessions, and an app-based peer support group, can decrease sedentary time (time spent sitting/lying down and inactive) in adolescents and young adults (AYAs) with acute lymphoblastic leukemia (ALL) receiving maintenance chemotherapy. The main questions it aims to answer are:

* Is the intervention a feasible and acceptable way to decrease sedentary time among adolescents and young adults (AYAs) with ALL?
* Does the intervention show evidence that it may decrease sedentary time?
* Does the intervention show evidence that it may increase quality of life, reduce inflammation, and improve glucose and lipid metabolism?

Participants will use their fitness tracker with reminders to move as well as support from other intervention participants and coaching with study staff to gradually decrease their sedentary time over 10 weeks. Researchers will compare participant pre- and post-intervention study measures to see if the program may be helpful to decrease sedentary time in adolescents and young adults (AYAs) with ALL. All participants will wear an activity tracker on the thigh for 7 days at the beginning and end of the study as well as complete quality of life questionnaires. Study labs will be collected three times (baseline, 8 weeks, and 12 weeks) over the course of the 12-week study. All in-person study visits and labs will occur in conjunction with Oncology clinic visits for maintenance chemotherapy.

Conditions

  • Acute Lymphoblastic Leukemia (ALL)

Interventions

BEHAVIORAL

Sedentary time intervention

Tests the effect of a multi-component mobile health (mHealth) intervention on reducing sedentary behavior among adolescents and young adults (AYAs) with ALL during maintenance therapy. The intervention includes an app-based peer support group for study participants via WhatsApp, individualized coaching sessions with study staff, and prompts to move delivered via a Fitbit wearable fitness tracker.

Sponsors & Collaborators

  • St. Baldrick's Foundation

    collaborator OTHER

  • Rally Foundation for Childhood Cancer Research

    collaborator OTHER

  • Children's Hospital Los Angeles

    lead OTHER

Principal Investigators

  • Brittany J Ivory (Van Remortel), MD, MPH · Children's Hospital Los Angeles

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2025-12-10
Completion
2025-12-10

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT06182163 on ClinicalTrials.gov