- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT02496728
NUYou:mHealth Intervention to Preserve and Promote Ideal Cardiovascular Health (NUYou)
American Heart Association Strategically Focused Research Network: mHealth Intervention to Preserve and Promote Ideal Cardiovascular Health
Обзор исследования
Статус
Условия
Подробное описание
Freshman college students at Northwestern University will be cluster randomized to two groups based on their dorm. The intervention for one group will target smoking, physical activity, BMI and consumption of fruits and vegetables. The intervention in the second group will target traveling behavior, sexual risk behaviors, sunscreen use and hydration. Baseline health and lifestyle measures will be assessed for each participant prior to intervention. Health assessments will measure height, weight, fasting glucose, total cholesterol and carbon monoxide. The lifestyle measure will ask questions about physical activity, diet, alcohol and tobacco use, safe sex practices, driving habits, and sunscreen use. These same measures will be repeated during the fall of the students' sophomore and junior years.
Participants will be given a mobile application and encouraged to track some behaviors. In addition, participants will be asked to answer weekly questions regarding health behaviors.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
Illinois
-
Chicago, Illinois, Соединенные Штаты, 60611
- Northwestern University
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Freshman at Northwestern University in the fall of 2015
- Live on campus
- Read, write and speak English
- Own an Iphone or Android smart phone
Exclusion Criteria:
- Pregnant or trying to become pregnant
- Established cardiovascular disease
- Unstable psychiatric or medical condition
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Cardiovascular Health
Participants will be given the results of their health assessment and feedback regarding their health behaviors and overall health.
Recommendations for change will be given if warranted.
Participants will download the study's mobile health application on their smartphone.
They will then be asked to report once a week about their health behaviors on the application.
Participants will also be asked to self-monitor health behaviors that are not already at ideal levels using the study application (environmental cues).
Participants will be asked to join a secret Facebook group where informational materials will be posted, participants can post about study health behaviors and social interaction around health behaviors can occur (social support and environmental cues).
|
An application on a smart phone that is designed to help individuals self-monitor health behaviors.
Text messages, informational posts and reminders supporting healthy behaviors.
Participants may interact with each other through a private Facebook group.
Educational materials regarding healthy behaviors.
|
|
Активный компаратор: Whole Health
Participants will be given the results of their health assessment.
They will then receive educational materials about sunscreen use, safe sex, hydration and vehicular safety.
Participants will download the study's mobile health application on their smartphone.
They will then be asked to report once a week about their health behaviors on the application.
Participants will also be asked to self-monitor how much water they drink using the study application.
Participants will be asked to join a secret Facebook group where informational materials will be posted, they can post about study health behaviors and social interaction around health behaviors can occur (social support and environmental cues).
|
An application on a smart phone that is designed to help individuals self-monitor health behaviors.
Text messages, informational posts and reminders supporting healthy behaviors.
Participants may interact with each other through a private Facebook group.
Educational materials regarding healthy behaviors.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
American Heart Association MyLifeCheck (Simple 7) score as a measure of cardiovascular health
Временное ограничение: 2 years
|
Participant's Simple 7 score is the sum of 7 cardiovascular health metrics attained at ideal levels as defined by American Heart Association.
1) physically active - Exercising at least 150 minutes of moderate or 75 minutes of vigorous physical activity per week.
2) Good diet quality - Eating 5 servings of fruits and vegetables per day, at least 3 servings of whole grain, and no more than 16 oz. of soda per day, rarely or never eats high sodium foods or processed meats.
3) nonsmoking - nonsmoker for at least a year.
4) not overweight - BMI < 25 kg/m2.
5) normoglycemic - fasting glucose < 100 mg/dl.
6) not hypercholesterolemic : total Cholesterol < 200 mg/dl.
7) not hypertensive.
Blood Pressure <120/<80.
|
2 years
|
Соавторы и исследователи
Спонсор
Соавторы
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
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
- 14SFRN20480260
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
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. .