Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: 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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Acute Lymphoblastic Leukemia (ALL) Behavior Cardiometabolic Health Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Sedentary Behavior Sedentary Behavior / Physical Inactivity

Age range

13 year–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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.)

Exclusion criteria

  • 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.
  • Unable to complete study-related surveys.
  • Pregnancy.
  • Current imprisonment.

Treatment and study plan

ReSeT2 Intervention

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Daily Sitting Time Measured by Accelerometry

    Time frame: Baseline and Week 12 (change from Baseline to Week 12).

    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.

  2. Change in Time Spent in Prolonged Sedentary Bouts

    Time frame: Baseline and Week 12 (change from Baseline to Week 12).

    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.

  3. Change in Daily Step Count

    Time frame: Baseline and Week 12 (change from Baseline to Week 12).

    Change from Baseline to Week 12 in average daily step count measured by the ActivPAL4 accelerometer and compared between intervention and control groups

  4. Change in Self-Reported Sitting Time

    Time frame: Baseline and Week 12 (change from Baseline to Week 12)

    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.

  5. Study Retention Rate

    Time frame: Up to Week 12.

    Participant retention, defined as the proportion of enrolled participants who complete the Week 12 assessment. This feasibility measure will be summarized descriptively.

  6. Fitbit Wear Adherence

    Time frame: Throughout the 10-week intervention period.

    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.

  7. Intervention Acceptability Survey Responses

    Time frame: Week 12

    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.

Other outcomes

  1. Change in Body Mass Index (BMI)

    Time frame: Baseline and Week 12 (change from Baseline to Week 12).

    Change from Baseline to Week 12 in body mass index (kg/m²) calculated from clinically obtained height and weight measurements.

  2. Change in Waist Circumference

    Time frame: Baseline and Week 12 (change from Baseline to Week 12).

    Change from Baseline to Week 12 in waist circumference (cm) measured by study staff.

  3. Change in Blood Pressure

    Time frame: Baseline and Week 12 (change from Baseline to Week 12).

    Change from Baseline to Week 12 in resting systolic and diastolic blood pressure obtained during routine clinical care.

  4. Change in Resting Heart Rate

    Time frame: Baseline and Week 12 (change from Baseline to Week 12).

    Change from Baseline to Week 12 in resting heart rate (beats per minute) obtained during routine clinical care.

  5. Change in Hemoglobin A1c

    Time frame: Baseline and Week 12 (change from Baseline to Week 12).

    Change from Baseline to Week 12 in hemoglobin A1c (HbA1c, %) as a measure of glucose metabolism

  6. Change in Fructosamine

    Time frame: Baseline and Week 12 (change from Baseline to Week 12).

    Change from Baseline to Week 12 in serum fructosamine concentration as a measure of short-term glucose control.

  7. Change in High-Sensitivity C-Reactive Protein

    Time frame: Baseline and Week 12 (change from Baseline to Week 12).

    Change from Baseline to Week 12 in high-sensitivity C-reactive protein (hs-CRP) concentration as a biomarker of systemic inflammation

  8. Change in Lipid Profile

    Time frame: Baseline and Week 12 (change from Baseline to Week 12).

    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.

  9. Change in Health-Related Quality of Life

    Time frame: Baseline and Week 12 (change from Baseline to Week 12).

    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.

  10. Change in Fatigue

    Time frame: Baseline and Week 12 (change from Baseline to Week 12).

    Change from Baseline to Week 12 in Pediatric Quality of Life Inventory (PedsQL) Multidimensional Fatigue Scale scores.

  11. Change in Self-Efficacy

    Time frame: Baseline and Week 12 (change from Baseline to Week 12).

    Change from Baseline to Week 12 in NIH Toolbox Self-Efficacy Questionnaire standardized scores, with higher scores indicating greater perceived self-efficacy.

Study contacts

Contact information is provided by the study sponsor or research team.

Brittany Ivory, MD

CONTACT

[email protected]

3233761067

Rosy Romero

CONTACT

[email protected]

3233761067

Sponsors and collaborators

Lead sponsor

Children's Hospital Los Angeles

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.