- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07593677
Motivating Activity Through Text Communications - Helping Adults Increase Movement (MATCH AIM)
Motivating Activity Through Text - Comparing Human and AI Messages (MATCH AIM) Trial
The goal of this clinical trial is to compare the effect of different types of text messages on physical activity levels of middle-aged and older adults and to determine whether these messages are effective in adults age 40 and older who are engaging in less than 90 minutes per week of moderate or higher intensity physical activity. The main questions it aims to answer are:
- Which types of motivational messages show the greatest effects on changes in daily step counts in a 3-month precision text messaging intervention?
- What are the effects of personalized text messages on automatic affective evaluations, habit strength (experienced automaticity), exercise identity, working memory capacity, and processing speed?
Participants will:
- Wear a Fitbit activity tracker continuously for 3 months and are encouraged to continue wearing it through 6 months.
- Wear an activPAL activity monitor on their thigh for 7-day assessment periods at the beginning of the study, at 3 months, and at 6 months.
- Complete 3 cognitive assessments ("brain games") per day on their smartphone during the 7-day assessment periods at baseline, 3 months, and 6 months.
- Be asked to set goals to increase their daily steps over the first 3 months of the study.
- Receive up to 4 motivational text messages per day for 3 months to encourage physical activity.
- Keep study-related apps (Fitbit app, AIM app, MetricWire app) open in the background on their smartphone.
- Complete questionnaires at the beginning of the study, at 3 months, and at 6 months
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Ann M Mehringer
- Номер телефона: 734-647-6050
- Электронная почта: amehring@umich.edu
Места учебы
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Michigan
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Ann Arbor, Michigan, Соединенные Штаты, 48109
- Рекрутинг
- University of Michigan
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Главный следователь:
- David E Conroy, PhD
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Контакт:
- David E Conroy, PhD
- Номер телефона: 734-647-8404
- Электронная почта: deconroy@umich.edu
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Контакт:
- Ann M Mehringer
- Номер телефона: 734-647-6050
- Электронная почта: amehring@umich.edu
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Be 40 years of age or older
- Own a smartphone running an Android or iOS operating system
- Have proficiency with the English language
- Be capable of providing informed consent
- Be able to perform moderate physical activity without restrictions
- Be willing to complete the entire 6-month protocol
- Be willing to establish a 12-hour window - beginning no later than 9:45 am and ending no later than 9:45 pm - for receiving text messages.
Exclusion Criteria:
- Residing outside of the continental United States
- Self-reporting 90 minutes or more of moderate-to-vigorous intensity physical activity per week
- contraindications to normal physical activity as identified on the Physical Activity Readiness Questionnaire (PAR-Q)
- Mobility restrictions that interfere with unassisted physical activity
- Being pregnant or planning to become pregnant during the study
- Planning to undergo surgery during the course of the study protocol
- Having a prior diagnosis of Alzheimer's disease or a related dementia
- Evidence of mild cognitive impairment as indicated by a mini-Montreal Cognitive Assessment (MoCA) test score of 12 or higher
- Concurrent participation in another study involving weight loss or physical activity
- Failure to respond to at least 85% of Ecological Momentary Assessment (EMA) prompts during the 7-day qualification phase.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Активный компаратор: Validated library of text messages
Participants in this arm will receive motivational text messages that have been written and used in previous studies.
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Participants will receive up to 4 motivational text messages per day during a self-selected 12-hour window. These messages focus on two content areas: 1) Move more, and 2) sit less. Delivery of these messages occurs in two phases:
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Экспериментальный: Newly created text messages
Participants in this arm will receive motivational text messages that have not been used in previous studies.
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Participants will receive up to 4 motivational text messages per day during a self-selected 12-hour window. These messages focus on two content areas: 1) Move more, and 2) sit less. Delivery of these messages occurs in two phases:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Daily Step Count
Временное ограничение: The activPAL is worn on the thigh for a 7-day assessment period before the intervention begins (baseline), after 3 months of intervention, and then again 3 months after the intervention is complete. The total time frame is 6 months.
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The primary outcome measure is the average daily step count, which is assessed using a blinded, research-grade activPAL activity monitor, worn on the thigh for a 7-day assessment period.
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The activPAL is worn on the thigh for a 7-day assessment period before the intervention begins (baseline), after 3 months of intervention, and then again 3 months after the intervention is complete. The total time frame is 6 months.
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Mechanisms of Behavior Change for Adherence: Habit Strength
Временное ограничение: These secondary outcomes are collected at the same major time points as the primary outcome: baseline (month 0), post-intervention (month 3), and follow-up (month 6).
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Habit Strength will be assessed using the Behavioral Automaticity Index from the Self-Report Habit Index to measure how automatic the exercise behavior has become.
Scores are calculated as the average item responses and range from 1 to 7 with higher scores reflecting greater experienced automaticity (i.e., stronger habits).
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These secondary outcomes are collected at the same major time points as the primary outcome: baseline (month 0), post-intervention (month 3), and follow-up (month 6).
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Mechanisms of Behavior Change for Adherence: Exercise Identity (Reflective)
Временное ограничение: These secondary outcomes are collected at the same major time points as the primary outcome: baseline (month 0), post-intervention (month 3), and follow-up (month 6).
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Exercise Identity will be assessed using the Exercise Identity Scale to see how much participants view themselves as "exercisers".
Scores are based on the average item response and range from 1 to 7 with higher scores representing a stronger exercise identity.
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These secondary outcomes are collected at the same major time points as the primary outcome: baseline (month 0), post-intervention (month 3), and follow-up (month 6).
|
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Mechanisms of Behavior Change for Adherence: Automatic Affective Evaluations
Временное ограничение: These secondary outcomes are collected at the same major time points as the primary outcome: baseline (month 0), post-intervention (month 3), and follow-up (month 6).
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Automatic Affective Evaluations will be assessed using a Single-Category Implicit Association Test (SCIAT) to assess non-conscious attitudes toward physical activity.
Scores are standardized mean differences of response times between blocks of trials where physical activity is paired with unpleasant attributes and blocks of trials where physical activity is paired with pleasant attributes.
Higher scores indicate more favorable automatic affective evaluations of physical activity.
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These secondary outcomes are collected at the same major time points as the primary outcome: baseline (month 0), post-intervention (month 3), and follow-up (month 6).
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Ambulatory Cognitive Function: Processing Speed
Временное ограничение: These secondary outcomes are collected at the same major time points as the primary outcome: Baseline (month 0), post-intervention (month 3), and follow-up (6 month).
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Processing Speed will be assessed with the Mobile Monitoring of Cognitive Change (M2C2) Symbol Search Task.
Scores are based on response times for accurate trials so there is no fixed range for scores.
Shorter response times indicate faster (better) processing speed; longer response times indicate slower (worse) processing speed.
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These secondary outcomes are collected at the same major time points as the primary outcome: Baseline (month 0), post-intervention (month 3), and follow-up (6 month).
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Ambulatory Cognitive Function: Working Memory Capacity
Временное ограничение: These secondary outcomes are collected at the same major time points as the primary outcome: Baseline (month 0), post-intervention (month 3), and follow-up (6 month).
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Working Memory Capacity will be measured using the M2C2 Grid Memory Task.
Scores are based on response accuracy measured as a Euclidean distance score.
Shorter distance scores indicate more working memory capacity; longer distance scores indicate less working memory capacity.
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These secondary outcomes are collected at the same major time points as the primary outcome: Baseline (month 0), post-intervention (month 3), and follow-up (6 month).
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Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: David E Conroy, PhD, University of Michigan
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- HUM00262651
- P30AG086637 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Сроки обмена IPD
Критерии совместного доступа к IPD
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- МКФ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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