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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 lipca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

50

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: 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
Brak interwencji: Usual Care Control
Participants continue standard clinical care and complete study assessments without receiving the ReSeT2 intervention.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in Total Sedentary Time
Ramy czasowe: 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).

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in Daily Sitting Time Measured by Accelerometry
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Change in Body Mass Index (BMI)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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).

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Children's Hospital Los Angeles

Śledczy

  • Główny śledczy: Brittany Ivory, MD, Children's Hospital Los Angeles

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 września 2026

Zakończenie podstawowe (Szacowany)

23 listopada 2028

Ukończenie studiów (Szacowany)

23 grudnia 2028

Daty rejestracji na studia

Pierwszy przesłany

29 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

29 lipca 2026

Pierwszy wysłany (Rzeczywisty)

3 sierpnia 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

3 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

29 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • CHLA-26-00180

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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