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Behavioral Intervention

Reducing Sedentary Time for Leukemia (ReSeT in ALL Trial)

N/A
Recruiting
Led By Brittany J Van Remortel, MD, MPH
Research Sponsored by Children's Hospital Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
12-18 years of age at time of enrollment
Has completed at least one cycle (3 months) of maintenance chemotherapy and have at least once cycle (3 months) remaining
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to see if using a mobile health intervention, like a fitness tracker with reminders to move, coaching sessions, and peer support, can help reduce the amount of time adolescents with acute lymphob

Who is the study for?
This trial is for adolescents aged 12-18 with acute lymphoblastic leukemia who are sedentary, spending on average 8+ hours a day sitting or lying down. They must have completed at least one cycle of maintenance chemotherapy and be willing to reduce their sedentary time. Participants need internet access, a smartphone compatible with Fitbit and WhatsApp, and speak English fluently.
What is being tested?
The study tests if a mobile health intervention can decrease sedentary time in teens with ALL during maintenance chemotherapy. It includes using a fitness tracker with move reminders, coaching sessions, and an app-based support group over 10 weeks while monitoring quality of life and health changes.
What are the potential side effects?
Since the intervention involves lifestyle modification rather than medication, typical drug side effects aren't expected. However, increasing activity levels could potentially cause fatigue or discomfort initially as participants adjust to being more active.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 12 and 18 years old.
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I have finished one cycle of maintenance chemotherapy and have at least one more to go.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Average intervention participant fitness tracker wear time over 10 weeks
Number of participants enrolled at 6 months
Number of participants who have completed all baseline and exit questionnaires at 12 weeks
+1 more
Secondary study objectives
Change in average hours per day of uninterrupted sedentary time from baseline to 12 weeks
Change in average minutes per day of sedentary time from baseline to 12 weeks
Other study objectives
Change in C-reactive protein (CRP) level from baseline to 12 weeks
Change in C-reactive protein (CRP) level from baseline to 8 weeks
Change in HDL cholesterol level from baseline to 12 weeks
+8 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Sedentary time interventionExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Children's Hospital Los AngelesLead Sponsor
249 Previous Clinical Trials
5,074,644 Total Patients Enrolled
8 Trials studying Leukemia
446 Patients Enrolled for Leukemia
Brittany J Van Remortel, MD, MPHPrincipal InvestigatorChildren's Hospital Los Angeles
~14 spots leftby Jun 2025
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