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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 июля 2026 г. обновлено: 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.

Обзор исследования

Статус

Еще не набирают

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Оцененный)

50

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Rosy Romero
  • Номер телефона: 3233761067
  • Электронная почта: roromero@chla.usc.edu

Учебное резервное копирование контактов

  • Имя: Brittany Ivory, MD
  • Номер телефона: 3233761067
  • Электронная почта: bivory@chla.usc.edu

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Ребенок
  • Взрослый

Принимает здоровых добровольцев

Нет

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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.
Поведенческий: 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
Без вмешательства: Usual Care Control
Participants continue standard clinical care and complete study assessments without receiving the ReSeT2 intervention.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change in Total Sedentary Time
Временное ограничение: 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).

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change in Daily Sitting Time Measured by Accelerometry
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Другие показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change in Body Mass Index (BMI)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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).

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Children's Hospital Los Angeles

Следователи

  • Главный следователь: Brittany Ivory, MD, Children's Hospital Los Angeles

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

1 сентября 2026 г.

Первичное завершение (Оцененный)

23 ноября 2028 г.

Завершение исследования (Оцененный)

23 декабря 2028 г.

Даты регистрации исследования

Первый отправленный

29 июля 2026 г.

Впервые представлено, что соответствует критериям контроля качества

29 июля 2026 г.

Первый опубликованный (Действительный)

3 августа 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

3 августа 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

29 июля 2026 г.

Последняя проверка

1 июля 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • CHLA-26-00180

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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