Acute Lymphoblastic Leukemia (ALL)NCT07742891
ReSeT in ALL 2: A Randomized, Controlled Pilot Trial Testing an Optimized, Multi-component Mobile Health Intervention to Reduce Sedentary Time in Early Adolescents and Young Adults (eAYAs) With ALL During Maintenance Therapy
A study testing ReSeT2 Intervention in people with Acute Lymphoblastic Leukemia (ALL) and Sedentary Behavior / Physical Inactivity, run by Children's Hospital Los Angeles.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 to 22 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia (ALL), Sedentary Behavior / Physical Inactivity, Cardiometabolic Health
- What is being tested?
- ReSeT2 Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 23 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 13-22 years at the time of enrollment.
- Diagnosis of lymphoblastic leukemia or lymphoma treated with Children's Oncology Group (COG)-based maintenance chemotherapy (B-ALL, T-ALL, MPAL).
- Patients with a history of relapsed disease are eligible if currently in second (or greater) remission and receiving COG-based maintenance therapy.
- Completed at least 1 month of maintenance therapy (through maintenance cycle 1, day 29) and have at least one maintenance cycle (approximately 3 months) remaining.
- Patients receiving nelarabine-containing maintenance cycles are eligible.
- Self-reported sedentary lifestyle with an average of 4 or more leisure-time hours per day spent sedentary.
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- Willing to reduce sedentary time.
- Parent/legal guardian available for consent (if applicable) and participant available for assent/consent as applicable.
- Access to the internet and a smartphone compatible with Fitbit and GroupMe (participant's or parent/guardian's device).
- Ability to participate in virtual sessions with study staff.
- Fluent in English. (Parents/guardians do not need to be English-speaking if consent can be completed in their primary language.)
Who cannot join
- Evidence of recurrent or metastatic disease.
- Inability to obtain informed consent/assent.
- Medical contraindication to daily standing and light physical activity (>1.5 METs).
- Intellectual disability or developmental delay that limits the ability to fully participate in the study intervention.
- Unable to obtain study laboratory tests
- Unable to independently complete quality-of-life surveys accurately.
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- Unable to complete study-related surveys.
- Pregnancy.
- Current imprisonment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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:
Read more
- Does the ReSeT2 intervention reduce device-measured total sedentary time (minutes/day) from baseline to Week 12 compared with usual care?
- Does the ReSeT2 intervention improve other sedentary behavior measures, feasibility and acceptability outcomes, and exploratory health outcomes such as cardiometabolic health, quality of life, and self-efficacy?
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:
- Complete baseline and Week 12 assessments, including questionnaires, clinical measurements, laboratory tests, and 7-day accelerometer wear periods.
- Be randomized to either the ReSeT2 intervention group or usual care.
- If assigned to the intervention group:
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.
- Conditions
- Acute Lymphoblastic Leukemia (ALL), Sedentary Behavior / Physical Inactivity, Cardiometabolic Health
- Being tested
- ReSeT2 Intervention
- Keywords
- Sedentary Behavior, Acute Lymphoblastic Leukemia (ALL), Mobile Health (mHealth) Intervention, Adolescents and Young Adults (AYA)
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReSeT2 InterventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| ReSeT2 Intervention | Experimental | 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. Receives: Behavioral: ReSeT2 Intervention |
| Usual Care Control | No intervention | Participants continue standard clinical care and complete study assessments without receiving the ReSeT2 intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 12 (change from Baseline to Week 12).
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion23 Nov 2028 (estimated)
- Study completion23 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic Leukemia (ALL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Freyer, DO, MS, Children's Hospital Los Angeles
- Investigators
- Brittany Ivory, MD, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07742891
- Sponsor's protocol ID
- CHLA-26-00180
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ReSeT in ALL 2: A Randomized, Controlled Pilot Trial Testing an Optimized, Multi-component Mobile Health Intervention to Reduce Sedentary Time in Early Adolescents and Young Adults (eAYAs) With ALL During Maintenance Therapy
- ClinicalTrials.gov ID
- NCT07742891
- Acronym / sponsor ID
- CHLA-26-00180
- Conditions
- Acute Lymphoblastic Leukemia (ALL), Sedentary Behavior / Physical Inactivity, Cardiometabolic Health
- Keywords
- Sedentary Behavior, Acute Lymphoblastic Leukemia (ALL), Mobile Health (mHealth) Intervention, Adolescents and Young Adults (AYA)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 23 Nov 2028 (estimated)
- Study completion
- 23 Dec 2028 (estimated)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the ReSeT2 intervention reduce device-measured total sedentary time (minutes/day) from baseline to Week 12 compared with usual care?
- Does the ReSeT2 intervention improve other sedentary behavior measures, feasibility and acceptability outcomes, and exploratory health outcomes such as cardiometabolic health, quality of life, and self-efficacy?
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:
- Complete baseline and Week 12 assessments, including questionnaires, clinical measurements, laboratory tests, and 7-day accelerometer wear periods.
- Be randomized to either the ReSeT2 intervention group or usual care.
- If assigned to the intervention group:
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ReSeT2 Intervention | Experimental | Behavioral: ReSeT2 InterventionParticipants 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. |
| Usual Care Control | No intervention | –Participants continue standard clinical care and complete study assessments without receiving the ReSeT2 intervention. |
Who may qualify
- Ages
- 13 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Age 13-22 years at the time of enrollment.
- Diagnosis of lymphoblastic leukemia or lymphoma treated with Children's Oncology Group (COG)-based maintenance chemotherapy (B-ALL, T-ALL, MPAL).
- Patients with a history of relapsed disease are eligible if currently in second (or greater) remission and receiving COG-based maintenance therapy.
- Completed at least 1 month of maintenance therapy (through maintenance cycle 1, day 29) and have at least one maintenance cycle (approximately 3 months) remaining.
- Patients receiving nelarabine-containing maintenance cycles are eligible.
Key exclusion criteria (9 listed)
- Evidence of recurrent or metastatic disease.
- Inability to obtain informed consent/assent.
- Medical contraindication to daily standing and light physical activity (>1.5 METs).
- Intellectual disability or developmental delay that limits the ability to fully participate in the study intervention.
- Unable to obtain study laboratory tests
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReSeT2 InterventionA 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 | Behavioural | ReSeT2 Intervention |
Primary outcome
Change in Total Sedentary Time
Time frame: Baseline and Week 12 (change from Baseline to Week 12).
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.
7 secondary outcomes
Change in Daily Sitting Time Measured by Accelerometry
Time frame: Baseline and Week 12 (change from Baseline to Week 12).
Change in Time Spent in Prolonged Sedentary Bouts
Time frame: Baseline and Week 12 (change from Baseline to Week 12).
Change in Daily Step Count
Time frame: Baseline and Week 12 (change from Baseline to Week 12).
Change in Self-Reported Sitting Time
Time frame: Baseline and Week 12 (change from Baseline to Week 12)
Study Retention Rate
Time frame: Up to Week 12.
Fitbit Wear Adherence
Time frame: Throughout the 10-week intervention period.
Intervention Acceptability Survey Responses
Time frame: Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brittany Ivory, MD principal investigator
Children's Hospital Los Angeles
Questions about this trial
What is this clinical trial studying?
A study testing ReSeT2 Intervention in people with Acute Lymphoblastic Leukemia (ALL) and Sedentary Behavior / Physical Inactivity, run by Children's Hospital Los Angeles.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rosy Romero (3233761067, roromero@chla.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Sedentary Time (time frame: Baseline and Week 12 (change from Baseline to Week 12).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.