Ecological Momentary Assessment of Smoking Triggers, Needs, and Cigarette Forgoing (spark Forgo)
This study will evaluate a smartphone-based program designed to support adults who smoke cigarettes. Participants will use the spark app to complete brief surveys during the day and a daily evening survey about their smoking urges, smoking, decisions not to smoke, and everyday experiences. Participants will also log cigarettes when they smoke. After some cigarette logs, participants will answer a few additional questions about their situation and feelings; after others, they will only log the cigarette.
The study has three phases. In the first phase, participants will complete surveys and cigarette logs without receiving intervention messages. In the second phase, they will receive motivational messages at random times. In the third phase, message timing and content will be tailored using information collected during the earlier phases. The study will examine whether personalized motivational messages can help participants forgo smoking in daily life.
Обзор исследования
Статус
Статус
Условия
Условия
Вмешательство/лечение
Вмешательство/лечение
Подробное описание
This study uses a within-person, phased ecological momentary assessment (EMA) and ecological momentary intervention (EMI) design to characterize momentary factors associated with cigarette smoking and smoking forgoing and to evaluate non-adaptive and adaptive motivational messaging delivered via the *spark* smartphone platform.
During all study phases, participants will complete four randomly timed EMA assessments per day during predefined waking hours and a daily evening survey. EMA assessments will assess momentary contextual factors, including current activity or routine, physical environment, social context, affective and cognitive states, smoking urges or craving, cigarette use since the previous assessment, and instances in which a smoking urge occurred without smoking (i.e., smoking forgoing). Evening surveys will assess daily smoking-related attitudes, cognitions, and behaviors.
Participants may also initiate an event-contingent entry whenever they smoke a cigarette. Each self-initiated entry will record the smoking event. Following each cigarette log, the app will randomly assign, with equal probability, whether the participant completes additional questions about the smoking context and feeling states or only logs the cigarette. To minimize assessment burden, randomly timed EMA prompts will not be delivered until at least one hour after completion of a self-initiated cigarette survey.
The study includes three phases. During the EMA Observation Phase, participants will complete EMA assessments, evening surveys, and event-contingent cigarette logs; no intervention messages will be delivered. During the Non-Adaptive EMI Phase, participants will continue these assessments and receive motivational messages delivered at randomly selected times, without tailoring to participant behavior or context. During the Adaptive EMI Phase, participants will continue all assessments and receive motivational messages at times determined by predictive models developed using data from the first two phases. Message content will be adapted based on the estimated likelihood of successful smoking forgoing in response to momentary contexts and internal states.
Where technically feasible and permitted by participant consent, passive smartphone-based data may be collected, including geolocation-derived patterns, time-stamped device-activity indicators, and environmental-context variables such as local weather conditions. These data will be used to enhance characterization of contextual factors associated with smoking urges, smoking behavior, smoking forgoing, and responsiveness to motivational intervention delivery.
Тип исследования
Тип исследования
Регистрация (Оцененный)
Регистрация
Фаза
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
Контакты исследования
- Имя: Amanda L Rebar, PhD
- Номер телефона: 5822030147
- Электронная почта: arebar@mailbox.sc.edu
Учебное резервное копирование контактов
- Имя: Desiree Vidana-Perez, PhD
- Номер телефона: 839-201-7629
- Электронная почта: desireev@mailbox.sc.edu
Критерии участия
Критерии приемлемости
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Age 21 years or older.
- Has smoked at least 100 cigarettes in their lifetime.
- Currently smokes cigarettes every day.
- Smokes 10 or fewer cigarettes per day.
- Owns a compatible smartphone with reliable internet access and is willing to install and use the *spark* study application.
- Able to read and understand English.
- Willing and able to complete smartphone-based assessments, self-initiated cigarette-event logs, and daily evening surveys for the study duration.
- Able and willing to provide informed consent.
Exclusion Criteria:
- Current use of electronic cigarettes or vaping products.
- Unable to provide informed consent.
- Does not have a compatible smartphone or reliable internet access.
- Unable to complete study procedures because of a cognitive, visual, motor, or other impairment not accommodated by the study procedures.
- Currently enrolled in another smoking-cessation intervention study that would conflict with study participation.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Количество рук
Оружие и интервенции
Группа участников / АрмияГруппа участников / Армия |
Вмешательство/лечениеВмешательство/лечение |
|---|---|
|
Экспериментальный: Single Group (EMA/EMI sequence)
All participants complete three phases in sequence: an EMA Observation Phase with no intervention messages; a Non-Adaptive EMI Phase with randomly timed motivational messages; and an Adaptive EMI Phase with motivational messages timed and tailored using predictive models. Participants complete EMA and evening surveys throughout and may self-initiate cigarette-event logs. |
Smartphone-delivered motivational messages provided at randomly selected times during the Non-Adaptive EMI Phase. Message timing and content are not tailored using participant behavior, context, or assessment data. Smartphone-delivered motivational messages provided during the Adaptive EMI Phase. Message timing is determined using predictive models developed from earlier study-phase data, and message content is adapted to the participant's estimated likelihood of successfully forgoing smoking in their current context. |
Что измеряет исследование?
Первичные показатели результатов
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Percentage of weekly smoking urge episodes in which smoking is forgone
Временное ограничение: During the 21-day study period
|
Smoking forgoing will be assessed using study-specific ecological momentary assessment (EMA) item: "Since the last prompt (check-in or smoking report), have you *chosen* to skip any cigarettes that you normally would have smoked?" (yes/no). The outcome is the percentage of participant-reported smoking urge episodes per week. Higher percentages indicate more smoking forgoing. |
During the 21-day study period
|
|
Number of cigarettes smoked per day
Временное ограничение: During the 21-day study period
|
Cigarette smoking will be assessed using count of the participant-initiated cigarette-event logs. The outcome is the mean number of cigarettes smoked per participant per week during the study period. |
During the 21-day study period
|
Вторичные показатели результатов
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Mean weekly momentary smoking urge/craving intensity score
Временное ограничение: During the 21-day study period
|
Current smoking urge or craving will be assessed using a study-specific EMA item: "How much do you crave (have an urging for) a cigarette right now? ". Participants will rate urge/craving on a 1-7 point scale, where 1 = 'not at all' and 7 = 'very much'. Higher scores indicate greater urge/craving. |
During the 21-day study period
|
|
Weekly EMA adherence
Временное ограничение: Throughout the study (week 1, 2, and 3).
|
Proportion of scheduled EMA prompts completed by participants per week |
Throughout the study (week 1, 2, and 3).
|
|
Smoking forgoing following motivational-message delivery
Временное ограничение: During the two bouts of 7-day Non-Adaptive EMI and Adaptive EMI phases of the 21-day study period.
|
Smoking-forgoing will be assessed using study-specific EMA urge reports and participant-initiated cigarette-event logs. The outcome is the percentage of participant-reported smoking-urge episodes in which the participant does not smoke a cigarette, calculated separately following delivery versus non-delivery of a motivational message at eligible decision points. Higher percentages indicate greater smoking forgoing. |
During the two bouts of 7-day Non-Adaptive EMI and Adaptive EMI phases of the 21-day study period.
|
|
Cigarette smoking following motivational-message delivery
Временное ограничение: During the two bouts of 7-day Non-Adaptive EMI and Adaptive EMI phases of the 21-day study period.
|
Cigarette smoking will be assessed using count of participant-initiated cigarette-event logs. The outcome is the mean number of cigarettes smoked per participant per week, calculated separately following delivery versus non-delivery of a motivational message at eligible decision points. |
During the two bouts of 7-day Non-Adaptive EMI and Adaptive EMI phases of the 21-day study period.
|
Соавторы и исследователи
Спонсор
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Начало исследования
Первичное завершение (Оцененный)
Первичное завершение
Завершение исследования (Оцененный)
Завершение исследования
Даты регистрации исследования
Первый отправленный
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Первый опубликованный
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее опубликованное обновление
Последнее отправленное обновление, отвечающее критериям контроля качества
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
Другие идентификационные номера исследования
- IRB00002615
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Individual participant data will not be shared because the intensive, time-stamped ecological momentary assessment data and potential passive smartphone data may create a risk of participant re-identification. Data will be retained and managed in accordance with the approved protocol, informed-consent materials, institutional policies, and applicable regulations.
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.
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. .