An interventional study of ReSeT2 Intervention in Acute Lymphoblastic Leukemia (ALL), Sedentary Behavior / Physical Inactivity and Cardiometabolic Health, sponsored by Children's Hospital Los Angeles. Not yet recruiting. Open to participants aged 13 Years to 22 Years. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by Children's Hospital Los Angeles · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn whether an optimized, multi-component mobile health intervention (ReSeT2) can reduce sedentary behavior in adolescents and young adults with acute lymphoblastic leukemia (ALL) who are receiving maintenance therapy. The participant population includes English-speaking adolescents and young adults aged 13-22 years with ALL or related lymphoid malignancies being treated at Children's Hospital Los Angeles.
The main questions it aims to answer are:
Researchers will compare participants receiving the ReSeT2 intervention with participants receiving usual care to see if the intervention leads to greater reductions in sedentary time and improvements in related health outcomes.
Participants will:
Use a Fitbit activity tracker with inactivity prompts for 10 weeks. Receive home activity equipment and goal-based incentives. Participate in individualized coaching sessions. Participate in a peer support GroupMe chat and optional in-person group sessions.
If assigned to the usual care group, continue standard clinical care and complete study assessments.
2,584 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 473 are open to participants now.
This study's planned enrollment of 50 is above the median of 40 across 1,952 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →Children's Hospital Los Angeles is the lead sponsor of 152 studies on the registry; 46 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive the 10-week ReSeT2 multi-component mobile health intervention, including a Fitbit with inactivity prompts, home activity equipment, goal-based incentives, individualized coaching sessions, a GroupMe peer support chat, and optional in-person group sessions.
Behavioral: ReSeT2 Intervention
Participants continue standard clinical care and complete study assessments without receiving the ReSeT2 intervention.
A 10-week multi-component mobile health sedentary behavior intervention that includes a Fitbit with inactivity prompts, home activity equipment, goal-based incentives, individualized coaching, a peer-support GroupMe chat, and optional in-person group sessions
Change in Total Sedentary Time
Change from Baseline to Week 12 in average daily total sedentary time (minutes/day), measured by the ActivPAL4 thigh-worn accelerometer. Daily sedentary time will be averaged across valid wear days (defined as ≥4 days with ≥10 hours/day of waking wear time) and compared between the ReSeT2 intervention and usual care control groups. The primary analysis will compare the change from Baseline to Week 12 between study arms.
Time frame: Baseline and Week 12 (change from Baseline to Week 12).
Change in Daily Sitting Time Measured by Accelerometry
Change from Baseline to Week 12 in average daily sitting time (minutes/day) measured using the ActivPAL4 accelerometer and compared between intervention and control groups.
Time frame: Baseline and Week 12 (change from Baseline to Week 12).
Change in Time Spent in Prolonged Sedentary Bouts
Change from Baseline to Week 12 in average daily time spent in prolonged sedentary bouts exceeding 60 minutes (minutes/day), measured by ActivPAL4 accelerometry and compared between intervention and control groups.
Time frame: Baseline and Week 12 (change from Baseline to Week 12).
Change in Daily Step Count
Change from Baseline to Week 12 in average daily step count measured by the ActivPAL4 accelerometer and compared between intervention and control groups
Time frame: Baseline and Week 12 (change from Baseline to Week 12).
Change in Self-Reported Sitting Time
Change from Baseline to Week 12 in self-reported sitting time (minutes/day) measured using the International Physical Activity Questionnaire (IPAQ) and compared between intervention and control groups.
Time frame: Baseline and Week 12 (change from Baseline to Week 12)
Study Retention Rate
Participant retention, defined as the proportion of enrolled participants who complete the Week 12 assessment. This feasibility measure will be summarized descriptively.
Time frame: Up to Week 12.
Fitbit Wear Adherence
Intervention adherence measured by Fitbit wear time during the 10-week intervention period. A valid wear day is defined as at least 10 hours of wear during waking hours based on continuous heart rate data.
Time frame: Throughout the 10-week intervention period.
Intervention Acceptability Survey Responses
Participant-reported acceptability of the ReSeT2 intervention assessed using a study-specific exit survey consisting of Likert-scale and open-ended questions evaluating satisfaction, perceived usefulness, and burden of intervention components.
Time frame: Week 12
Change in Body Mass Index (BMI)
Change from Baseline to Week 12 in body mass index (kg/m²) calculated from clinically obtained height and weight measurements.
Time frame: Baseline and Week 12 (change from Baseline to Week 12).
Change in Waist Circumference
Change from Baseline to Week 12 in waist circumference (cm) measured by study staff.
Time frame: Baseline and Week 12 (change from Baseline to Week 12).
Change in Blood Pressure
Change from Baseline to Week 12 in resting systolic and diastolic blood pressure obtained during routine clinical care.
Time frame: Baseline and Week 12 (change from Baseline to Week 12).
Change in Resting Heart Rate
Change from Baseline to Week 12 in resting heart rate (beats per minute) obtained during routine clinical care.
Time frame: Baseline and Week 12 (change from Baseline to Week 12).
Change in Hemoglobin A1c
Change from Baseline to Week 12 in hemoglobin A1c (HbA1c, %) as a measure of glucose metabolism
Time frame: Baseline and Week 12 (change from Baseline to Week 12).
Change in Fructosamine
Change from Baseline to Week 12 in serum fructosamine concentration as a measure of short-term glucose control.
Time frame: Baseline and Week 12 (change from Baseline to Week 12).
Change in High-Sensitivity C-Reactive Protein
Change from Baseline to Week 12 in high-sensitivity C-reactive protein (hs-CRP) concentration as a biomarker of systemic inflammation
Time frame: Baseline and Week 12 (change from Baseline to Week 12).
Change in Lipid Profile
Change from Baseline to Week 12 in fasting lipid measures, including total cholesterol, high-density lipoprotein cholesterol (HDL), low-density lipoprotein cholesterol (LDL), and triglycerides. This is an optional study procedure.
Time frame: Baseline and Week 12 (change from Baseline to Week 12).
Change in Health-Related Quality of Life
Change from Baseline to Week 12 in participant-reported Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale scores assessing physical, emotional, social, and school functioning.
Time frame: Baseline and Week 12 (change from Baseline to Week 12).
Change in Fatigue
Change from Baseline to Week 12 in Pediatric Quality of Life Inventory (PedsQL) Multidimensional Fatigue Scale scores.
Time frame: Baseline and Week 12 (change from Baseline to Week 12).
Change in Self-Efficacy
Change from Baseline to Week 12 in NIH Toolbox Self-Efficacy Questionnaire standardized scores, with higher scores indicating greater perceived self-efficacy.
Time frame: Baseline and Week 12 (change from Baseline to Week 12).
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Nov 2028, 26 months later.
Of 207 non-industry interventional studies with no phase under Precursor Cell Lymphoblastic Leukemia-Lymphoma, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 66. This study's planned 26 months is below that.
Counting every sponsor, half of 214 studies reached it within 32 months; a quarter within 12 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Precursor Cell Lymphoblastic Leukemia-Lymphoma →
Children's Hospital Los Angeles →