- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT02206893
Evaluating Consumer m-Health Services for User Engagement and Health Promotion: An Organizational Field Experiment
Introduction Chronic disease is prevalent and costly in the U.S. (Tu & Cohen, 2009). Poor eating habit is one factor that account for risk of chronic disease (Arsand, Varmedal, & Hartvigsen, 2007). Smartphone technology has been promising to improve preventive health outcomes. However, its great potential has not been widely applied to people's eating behaviors and its impact is unknown.
Professional and peer supports can improve health status (Elkjaer et al., 2010; Lorig et al., 1999; Perri, Sears, & Clark, 1993). However, the former is usually delivered didactically or passively with limited use of smartphones. There is also little evidence of the effect of peer support delivered by smartphones in the domain of healthy eating. This research aims to study what smartphone technology can do to upgrade professional and peer supports, and to evaluate the impact of these mobile-app enabled supports on people's behavior of healthy eating and user engagement.
Hypotheses
According to Social Cognitive Theory, we hypothesize the following:
- Mobile-enabled self-monitoring approach improves users' healthy eating behaviors through improved self-efficacy
- Professional support improves users' healthy eating behaviors through improved self-efficacy
- Peer support improves users' healthy eating behaviors through improved self-efficacy
- The amount of support is positively correlated with the change in behaviors and their determinants
Experiment Design The hypotheses will be examined bya 4-month randomized field experiment. 375 subjects will be recruited and assigned to one of the five arms to receive the corresponding tool for diet management at no cost.
Arm 1: a mobile App with both professional and peer support Arm 2: a mobile App with peer support only Arm 3: a mobile App with professional support only Arm 4: a mobile App without any support Arm 5: a non-mobile web App In addition to the App usage data, five surveys are conducted at baseline and the end of each month. Respondents will be compensated by $8 and a chance to win $200 for each completed survey.
Interventions
- All subjects receive the following interventions: an education package includes the importance of healthy eating, concept of MyPlate, personalized daily food plans; reminders throughout the study; goal setting capabilities;
- Self-monitoring provided by an Android App: a heuristic approach inspired by MyPlate to record their food consumption which allows users to record their meals by images and doesn't require estimations in cups and ounces; daily reports and trend reports
- Self-monitoring provided by the web App: a traditional approach to record their food consumption which requires estimations in cups and ounces, and no images are allowed; no daily reports and trend reports are provided
Professional support provided by a registered dietitian via the Android App: the supports include the following:
- Reply to users' messages regarding healthy eating
- Provide meal-specific comments on subjects' meal consumptions: one meal per week
- Provide feedback on the subjects' consumption patterns: once per week
Peer support provided by other subjects via the Android App: the App provides platforms for subjects who have the same interest to communicate to each other. The actions the subjects can do in the platforms include:
- Post images or texts related to healthy eating
- Share meals with their ratings
- Like/dislike others' posts
- Comment on others' posts e Create groups which allow subjects who have the same interest to join
Measurements
Dependent Variables
- Eating behavior: a score of healthiness of a meal will be assigned by a dietitian. The scores obtained by the same subject along the experiment compose the subject's eating behavior
- Engaging behavior: this is measured by the number of meals recorded by the subject in a week. The numbers for the same subject along the experiment compose the subject's engaging behavior
Independent Variables
- Level of peer support: this will be measured by a score representing the number of posts, likes, and comments received and given by a subject in a week
- Level of professional support: this will be measured by a score representing the number of messages or comments exchanged with the dietitian in a week
- Mediator Variables: self-efficacy, outcome expectation, and impediments will be measured by survey instruments
Data
- User Survey: characteristics and perceptions
- Mobile App: time, location, and contents of goal setting, meal entries, communications with professionals and peers
- Web App: contents of goal setting and meal entries
Analysis Confirmatory factor analysis and statistical modeling such as structural equation modeling and mixed models will be conducted to test our hypotheses.
Обзор исследования
Статус
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Pennsylvania
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Pittsburgh, Pennsylvania, Соединенные Штаты, 15213
- Carnegie Mellon University
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- age at least 18 years
- Android smartphone users
- having internet accessibility on the smartphone during the study period
Exclusion Criteria:
- currently participating in other similar programs
- having specific medical conditions that require specialized diets
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Mobile: Professional and peer support
A mobile app that provides both professional support and peer support
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Экспериментальный: Mobile: Peer support
A mobile app that provides peer support, but not professional support
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Экспериментальный: Mobile: Professional Support
A mobile app that provides professional support, but no peer support
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Активный компаратор: Mobile: No Support
A mobile app that provides neither peer support nor professional support
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Активный компаратор: Web: No Support
A web app that provides neither peer support, nor professional support
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Healthy Eating Behavior
Временное ограничение: 4 months after signed up
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This will be measured by a score representing the healthiness of each selected meal, evaluated by dietitians.
Specifically, the score is composed of three sub-scores: 1) portion of fruits and vegetables (7-point Likert scale); 2) portion of the entire meal (7-point Likert scale); 3) evaluators confidence level (4-point Likert scale).
One subject will get one score per week, and hence 16 scores in 4-months.
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4 months after signed up
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Engaging Behavior
Временное ограничение: 4 months after signed up
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This will be measured by the number of records submitted by the subject via the assigned tool in a week.
One subject will get one score per week, and hence 16 scores in 4-months.
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4 months after signed up
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Yi-Chin Lin, MS, Carnegie Mellon University
- Учебный стул: Rema Padman, PhD, Carnegie Mellon University
- Директор по исследованиям: Julie Downs, PhD, Carnegie Mellon University
- Директор по исследованиям: Vibhanshu Abhishek, PhD, Carnegie Mellon University
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 (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- HS14-249
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. .