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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

29. července 2026 aktualizováno: David Freyer, DO, MS, Children's Hospital Los Angeles

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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

50

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: ReSeT2 Intervention
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.
Behaviorální: 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
Žádný zásah: Usual Care Control
Participants continue standard clinical care and complete study assessments without receiving the ReSeT2 intervention.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Total Sedentary Time
Časové okno: 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.
Baseline and Week 12 (change from Baseline to Week 12).

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Daily Sitting Time Measured by Accelerometry
Časové okno: 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.
Baseline and Week 12 (change from Baseline to Week 12).
Change in Time Spent in Prolonged Sedentary Bouts
Časové okno: 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.
Baseline and Week 12 (change from Baseline to Week 12).
Change in Daily Step Count
Časové okno: 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
Baseline and Week 12 (change from Baseline to Week 12).
Change in Self-Reported Sitting Time
Časové okno: 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.
Baseline and Week 12 (change from Baseline to Week 12)
Study Retention Rate
Časové okno: 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.
Up to Week 12.
Fitbit Wear Adherence
Časové okno: 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.
Throughout the 10-week intervention period.
Intervention Acceptability Survey Responses
Časové okno: 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.
Week 12

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Body Mass Index (BMI)
Časové okno: 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.
Baseline and Week 12 (change from Baseline to Week 12).
Change in Waist Circumference
Časové okno: Baseline and Week 12 (change from Baseline to Week 12).
Change from Baseline to Week 12 in waist circumference (cm) measured by study staff.
Baseline and Week 12 (change from Baseline to Week 12).
Change in Blood Pressure
Časové okno: 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.
Baseline and Week 12 (change from Baseline to Week 12).
Change in Resting Heart Rate
Časové okno: 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.
Baseline and Week 12 (change from Baseline to Week 12).
Change in Hemoglobin A1c
Časové okno: 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
Baseline and Week 12 (change from Baseline to Week 12).
Change in Fructosamine
Časové okno: 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.
Baseline and Week 12 (change from Baseline to Week 12).
Change in High-Sensitivity C-Reactive Protein
Časové okno: 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
Baseline and Week 12 (change from Baseline to Week 12).
Change in Lipid Profile
Časové okno: 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.
Baseline and Week 12 (change from Baseline to Week 12).
Change in Health-Related Quality of Life
Časové okno: 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.
Baseline and Week 12 (change from Baseline to Week 12).
Change in Fatigue
Časové okno: 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.
Baseline and Week 12 (change from Baseline to Week 12).
Change in Self-Efficacy
Časové okno: 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.
Baseline and Week 12 (change from Baseline to Week 12).

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Children's Hospital Los Angeles

Vyšetřovatelé

  • Vrchní vyšetřovatel: Brittany Ivory, MD, Children's Hospital Los Angeles

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. září 2026

Primární dokončení (Odhadovaný)

23. listopadu 2028

Dokončení studie (Odhadovaný)

23. prosince 2028

Termíny zápisu do studia

První předloženo

29. července 2026

První předloženo, které splnilo kritéria kontroly kvality

29. července 2026

První zveřejněno (Aktuální)

3. srpna 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

3. srpna 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

29. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • CHLA-26-00180

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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