Enhancing Source Credibility in Tobacco Regulatory Communications
20 ноября 2020 г. обновлено: Adam Goldstein, MD, MPH, UNC Lineberger Comprehensive Cancer Center
This study will assess the impact of cigarette constituent messages with and without FDA source and quit information in a randomized controlled trial.
The investigators hypothesize that cigarette constituent messages will increase intention to quit compared to messages about littering cigarettes (the control).
The investigators also hypothesize that constituent messages that include FDA source and quit information will increase intention to quit compared to messages without that information.
Обзор исследования
Статус
Завершенный
Условия
Подробное описание
The Family Smoking Prevention and Tobacco Control Act delegates the U.S. Food and Drug Administration (FDA) to communicate the risks of smoking to the public, among other tobacco regulatory responsibilities. Little research exists about how FDA, as a regulatory agency, should develop and deliver these messages, and whether they should include their source information on the ads. This study will assess the impact of cigarette constituent messages with and without FDA source and quit information in a randomized controlled trial.
Recruitment: People interested in participating will complete an online screener. Study staff will invite people eligible based on the screener to enroll in the study.
Informed Consent: The consent form will be shared with people who are eligible based on the screener in the invitation email. At the beginning of the baseline survey, participants will again review the consent form and will be asked to provide consent in order to enroll in the study.
Randomization: At the end of the baseline survey, survey software will randomly assign participants to one of the three study arms. Participants will have an equal chance of being randomized to each study arm.
Assessment: Participants will complete 18 computer based surveys during the study. The first baseline survey will take around 20 minutes to complete on day 0. Participants will then receive a survey each morning for days 1-15 that will include behavior measures as well as their assigned study intervention. These surveys will take approximately 5 minutes to complete. Participants will then complete a 20-minute survey on day 16, and day 32.
Detailed description of the intervention: Participants will receive an email with a link to a survey each morning for 15 days. During that survey they will be shown one message from their condition. Each condition has 5 messages that will be repeated 3 times in a counterbalanced order. Study investigators designed the messages.
Тип исследования
Интервенционный
Регистрация (Действительный)
845
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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-
North Carolina
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Chapel Hill, North Carolina, Соединенные Штаты, 27599
- University of North Carolina at Chapel Hill
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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
От 18 лет до 65 лет (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
Inclusion Criteria:
- Have smoked at least 100 cigarettes in his or her lifetime
- Currently smoke cigarettes every day or some days
- Work or home access to the internet
- Email account that is regularly used
- Lives in the US
- Comfortable taking a survey in English
- Able to complete a survey on a computer
- Able to complete surveys delivered via email
- Able to complete 3, 20 minute surveys during the study
- Able to complete surveys in the morning for 15 days
Exclusion Criteria:
- Currently using pharmacotherapy, a quitline, or a quit smoking program or support group for smoking cessation
- Participated in a research study about smoking cigarettes or using other tobacco products in the last 3 months
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: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Constituent message with FDA and quitline
Messages about the chemical constituents of cigarette smoke will include text about chemicals in cigarette smoke and health effects of the chemicals, and an image of a person related to the health effect.
This arm will also include an FDA logo, and information about the benefits of quitting smoking and the quitline.
Each condition has 5 messages that will be repeated 3 times in a counterbalanced order.
Study investigators used text developed by investigators associated with our Center for Regulatory Research on Tobacco Communication.
Design of these messages was developed by our team.
|
Messages about the chemical constituents of cigarette smoke will include text about chemicals in cigarette smoke and health effects of the chemicals, and an image of a person related to the health effect.
This arm will also include an FDA logo, and information about the benefits of quitting smoking and the quitline.
Each condition has 5 messages that will be repeated 3 times in a counterbalanced order.
Study investigators used text developed by investigators associated with our Center for Regulatory Research on Tobacco Communication.
Design of these messages was developed by our team.
|
|
Экспериментальный: Constituent message without FDA and quitline
Messages about the chemical constituents of cigarette smoke will include text about chemicals in cigarette smoke and health effects of the chemicals, and an image of a person related to the health effect.
This arm is identical to the arm above, except that it does not include FDA source or quit information.
Each condition has 5 messages that will be repeated 3 times in a counterbalanced order.
Study investigators used text developed by investigators associated with our Center for Regulatory Research on Tobacco Communication.
Design of these messages was developed by our team.
|
Messages about the chemical constituents of cigarette smoke will include text about chemicals in cigarette smoke and health effects of the chemicals, and an image of a person related to the health effect.
This arm is identical to the arm above, except that it does not include FDA source or quit information.
Each condition has 5 messages that will be repeated 3 times in a counterbalanced order.
Study investigators used text developed by investigators associated with our Center for Regulatory Research on Tobacco Communication.
Design of these messages was developed by our team.
|
|
Другой: Littering message (Control)
Messages about littering cigarettes will include text designed to discourage people from littering their cigarette butts, and an image related to the message.
Each condition has 5 messages that will be repeated 3 times in a counterbalanced order.
Study investigators used text developed by investigators associated with our Center for Regulatory Research on Tobacco Communication.
Design of these messages was developed by our team.
|
Messages about littering cigarettes will include text designed to discourage people from littering their cigarette butts, and an image related to the message.
Each condition has 5 messages that will be repeated 3 times in a counterbalanced order.
Study investigators used text developed by investigators associated with our Center for Regulatory Research on Tobacco Communication.
Design of these messages was developed by our team.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Quit Intentions
Временное ограничение: day 16
|
Average quit intention score measured at 16 days by survey.
Quit intention measured with 3 questions, the final quit intention score is a mean of the response to the 3 questions, on a scale of 1 to 4, where 1 indicates low intention to quit, and 4 indicates a high intention to quit.
|
day 16
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Number of Cigarettes Smoked Each Day
Временное ограничение: days 1-15
|
Measured daily by survey
|
days 1-15
|
|
Number of Cigarettes Forgone Each Day
Временное ограничение: days 1-15
|
Measured daily by survey
|
days 1-15
|
|
Number of Cigarettes Butted Out Each Day
Временное ограничение: days 1-15
|
Measured daily by survey
|
days 1-15
|
|
Quit Attempts During the Study
Временное ограничение: days 16 and 32
|
Measured by survey
|
days 16 and 32
|
|
Awareness of Quitline
Временное ограничение: day 16
|
Measured by survey
|
day 16
|
|
Recall of Quitline Phone Number
Временное ограничение: day 16
|
Measured by survey
|
day 16
|
|
Use of Quitline During the Study
Временное ограничение: days 16 and 32
|
Measured by survey
|
days 16 and 32
|
|
Intention to Use the Quitline
Временное ограничение: days 16 and 32
|
Measured by survey.
Intention to use the quitline was measured with one item on a 1 to 4 scale, where 1 indicates a low likelihood of calling the quitline, and 4 indicates a high likelihood of calling the quitline.
|
days 16 and 32
|
|
Quit Intentions
Временное ограничение: day 32
|
Average quit intention score measured at 32 days by survey.
Quit intention measured with 3 questions, the final quit intention score is a mean of the response to the 3 questions, on a scale of 1 to 4, where 1 indicates low intention to quit, and 4 indicates a high intention to quit.
|
day 32
|
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Self Efficacy
Временное ограничение: days 16 and 32
|
Measured by survey.
Self efficacy measured with 1 question, on a scale of 1 to 5, where 1 indicates low self efficacy to quit, and 5 indicates a high self efficacy to quit smoking cigarettes.
|
days 16 and 32
|
|
Response Efficacy
Временное ограничение: days 16 and 32
|
Measured by survey.
Response efficacy measured with 1 question, on a scale of 1 to 5, where 1 indicates low response efficacy of quitting, and 5 indicates a high response efficacy of quitting smoking cigarettes.
|
days 16 and 32
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
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 (Действительный)
10 октября 2017 г.
Первичное завершение (Действительный)
6 мая 2018 г.
Завершение исследования (Действительный)
23 мая 2018 г.
Даты регистрации исследования
Первый отправленный
7 ноября 2017 г.
Впервые представлено, что соответствует критериям контроля качества
7 ноября 2017 г.
Первый опубликованный (Действительный)
13 ноября 2017 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
24 ноября 2020 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
20 ноября 2020 г.
Последняя проверка
1 ноября 2020 г.
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- 17-0610
- P50CA180907 (Грант/контракт NIH США)
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. .