NCT06182163Completed
Reduce Sedentary Time in Acute Lymphoblastic Leukemia
ReSeT in ALL: A Single-arm Feasibility Trial Testing a Multi-component Mobile Health Intervention to Reduce Sedentary Time in Adolescents and Young Adults (AYAs) With ALL During Maintenance Therapy
Source: ClinicalTrials.gov · Last updated 7 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 13 Dec 2023
- Start date
- 1 Jul 2024
- Primary completion date
- 17 Dec 2025
- Lead sponsor
- Children's Hospital Los Angeles
- NCT number
- NCT06182163
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 1 Jul 2024 to the primary completion date, 17 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Evidence of recurrent or metastatic disease
Lab values
- Unable to obtain laboratory studies
Other
- Inability to obtain consent/assent
- Medical contraindication to daily standing and light physical activity \[\>1.5 metabolic equivalents of task (METs)\]
- Intellectual disability or developmental delay which limits ability to fully participate in the study intervention
- Unable to accurately perform quality of life surveys independently
- Unable to complete study-related surveys
- Pregnancy or current imprisonment
Who the study is looking for
- 12-21 years of age at time of enrollment
- Diagnosis of lymphoblastic leukemia/lymphoma treated with Children's Oncology Group (COG)-based maintenance chemotherapy \[B-cell acute lymphoblastic leukemia/lymphoma (B-ALL/Ly), T-cell acute lymphoblastic leukemia/lymphoma (T-ALL/Ly), mixed phenotype acute leukemia (MPAL)\]
- Has completed at least one month of maintenance chemotherapy and has at least one cycle (3 months) remaining.
- Baseline sedentary lifestyle with a self-reported average of 4 or more leisure-time hours per day spent sedentary (verbal report)
- Willing to reduce their sedentary time
- Parent/legal guardian available for consent (if applicable), and patient available for assent or consent as applicable
- Has access to internet and smartphone compatible with Fitbit and WhatsApp (own or parent/legal guardian's)
- Ability to participate in virtual sessions with study staff
- Fluent in English (Parent/legal guardian does not need to be fluent in English as long as they can provide consent, if needed, in their primary language)
Age in the registry: 12 years to 21 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Hospital Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.