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The Effectiveness of an E-Intervention on Health Behavior Promotion in Chinese University Students

17 апреля 2019 г. обновлено: Yanping DUAN, Hong Kong Baptist University
Through the internet and mobile phone SMS technology, and by using the Health Action Process Approach model as a theoretical backdrop, this 8-week theory-based intervention study aimed at developing a healthy lifestyle by supporting physical activity (PA) and a healthy dietary for Chinese university students. The investigators would examine whether the two intervention groups improve the participants' motivation for PA and healthy diets in comparison to the control group; whether, with the help of an intervention program, students are able to increase the PA levels and healthy diet consumption, and whether there are different effects between the two intervention programs.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

For the main study, the sample size was estimated by using G*Power 3.1 software with MANOVA approach (repeated measure). For achieving small effect size of 0.15 (Lippke, Fleig, Wiedemann, & Schwarzer, 2015), with a power (1-β) of 0.8 and alpha of 0.05, the total sample size was 306. Assuming a drop-out rate of approximately 30%, a total of 399 participants were required for the study evaluation.

The effects of the intervention were evaluated by performing several analyses of MANOVA and MANCOVA measured at three points in time (8-week apart pre-post measures, and four weeks follow-up; T1-T3).In addition, moderated multiple mediation analysis was performed (Independent variable: intervention; Moderators: stage; Dependent variable: behavioural and social-cognitive outcomes). Baseline characteristics of participants who dropped out were compared with participants who finished the intervention to examine whether drop out is at random or determined by specific characteristics.

Тип исследования

Интервенционный

Регистрация (Действительный)

621

Фаза

  • Непригодный

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

  • Ребенок
  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria:

  • not professional athletes; not vegetarians
  • no contraindication with respect to the physical activity or fruit and vegetable consumption.
  • access to the Internet and a mobile phone.

Exclusion Criteria:

  • have the restriction of physical mobility
  • have fruit-vegetable related diseases such as diabetes or fruit allergies.

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: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Одинокий

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Intervention group 1
Students in the intervention group 1 received first 4-week treatment on physical activity followed by 4-week treatment on healthy dietary behaviour.
Поведенческий: E-intervention
The intervention will address the basic elements of the HAPA model via the use of behaviour change techniques. In line with Abraham and Michie (2008), we use several behaviour change techniques like providing information about behavioural risk and benefit of behaviour change, prompting intention formation, prompting barrier identification, providing instructions how to perform a behaviour, prompting specific goal setting and review of behavioural goals, providing feedback on performance, prompting practice and providing follow-up prompts, prompting to plan social support and finally prompting relapse prevention, also based on strategies used by other effective computer tailoring programs. Students attended e-health intervention session once a week with about 20 minutes each time.
Экспериментальный: Intervention group 2
Students in the intervention group 2 received first 4-week treatment on healthy dietary behaviour followed by 4-week treatment on physical activity.
Поведенческий: E-intervention
The intervention will address the basic elements of the HAPA model via the use of behaviour change techniques. In line with Abraham and Michie (2008), we use several behaviour change techniques like providing information about behavioural risk and benefit of behaviour change, prompting intention formation, prompting barrier identification, providing instructions how to perform a behaviour, prompting specific goal setting and review of behavioural goals, providing feedback on performance, prompting practice and providing follow-up prompts, prompting to plan social support and finally prompting relapse prevention, also based on strategies used by other effective computer tailoring programs. Students attended e-health intervention session once a week with about 20 minutes each time.
Без вмешательства: Control group
Students in the control group were not provided with any supportive treatments on physical activity or healthy dietary behaviour.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change of weekly amount of physical activity (PA)
Временное ограничение: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
The level of PA will be measured through the short Chinese version of the IPAQ questionnaire (Macfarlane et al., 2007). Participants will be asked to estimate the number of days and hours spent for vigorous, moderate and walking activities during the past week.
From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
Change of daily portions of fruit-vegetable intake (FVI)
Временное ограничение: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
The daily portions of FVI will be measured with four items, including fruit or vegetable juice, fruit, cooked or steamed vegetables, and raw vegetables (Rafferty et al., 2002). Respondents will be asked to count the number of portions of fruit and vegetables they consumed on average during a typical day.
From baseline to 9 weeks (at the end of intervention) and 1-month follow-up

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change of stage algorithm of behaviors change
Временное ограничение: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
For PA, participants will be asked "Please think about your typical weeks: Did you engage in PA at least 5 days per week for 30 minutes or more?" Regarding dietary, participants will be asked "Please think about what you have typically consumed during the last weeks: Did you eat five portions of fruit and vegetables per day?" Responses are based on a rating scale with verbal anchors ("No, and I do not intend to start"; "No, but I am considering it"; "No, but I seriously intend to start"; "Yes, but only for a brief period of time"; "Yes, and for a long period of time") and are designed like a rating scale (Lippke, Ziegelmann, Schwarzer, & Velicer, 2009).
From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
Change of outcome expectancies of PA and FVI
Временное ограничение: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
Outcome expectancies will be measured by two Pros items and two Cons items for each behavior (Schwarzer, Lippke, & Luszczynska, 2011).
From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
Change of self-efficacy of PA and FVI
Временное ограничение: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
Self-efficacy will be assessed with three dimensions consisting of motivational, maintenance and recovery self-efficacies with the stem "I am certain that…" followed by 5 items for PA such as "…I can be physically active permanently at a minimum of 5 days a week for 30 minutes even if it is difficult", or followed by 5 items for FVI such as "…I can eat 5 portions of fruit and vegetable a day even if it is difficult." (Luszczynska & Sutton, 2006).
From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
Change of risk perception of PA and FVI
Временное ограничение: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
Risk perception is adapted from Perloff and Fetzer (1986) and will be measured by 5 items.
From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
Change of intention of PA and FVI
Временное ограничение: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
Intention will be assessed by 3 items for each behavior (Lippke et al., 2009).
From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
Change of planning of PA and FVI
Временное ограничение: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
Planning will be distinguished into action planning and coping planning. Action planning will be assessed by 3 items for each behavior. Coping planning will be assessed by 3 items for each behavior (Schwarzer, 2008)
From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
Change of perceived social support of PA and FVI
Временное ограничение: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
For the perceived social support, the scale will be measured with the stem as "How do you perceived your environment?" followed by 3 items for PA such as"….People like my friends help me to stay physically active", or followed by 3 items for FVI such as "…People like my friends help me to eat healthily" (Jackson, Lippke & Gray, 2011).
From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
Change of compensatory health beliefs of PA and FVI
Временное ограничение: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
Compensatory health beliefs will be measured by 4 items (Knäuper, Rabiau, Cohen, & Patriciu, 2004).
From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
Change of perceived quality of life
Временное ограничение: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
This indicator will be assessed by using the short version of WHO Quality of Life-BREF (WHO, 1993). Respondents will be firstly asked about their general quality of life as "How would you rate your quality of life?", then 7 items in physical health sub-domain will be used, such as the example item "To what extent do you feel that physical pain prevents you from doing what you need to do?"
From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
Change of body mass index (BMI)
Временное ограничение: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
The participants will be asked to report body height (in cm) and body weight (in kg) for calculate the BMI.
From baseline to 9 weeks (at the end of intervention) and 1-month follow-up

Другие показатели результатов

Мера результата
Мера Описание
Временное ограничение
Demographic information
Временное ограничение: At baseline
These items include gender, age, study year, university name, and marital status.
At baseline

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Hong Kong Baptist University

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

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)

1 июня 2016 г.

Первичное завершение (Действительный)

31 декабря 2017 г.

Завершение исследования (Действительный)

28 февраля 2018 г.

Даты регистрации исследования

Первый отправленный

1 августа 2018 г.

Впервые представлено, что соответствует критериям контроля качества

8 августа 2018 г.

Первый опубликованный (Действительный)

14 августа 2018 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

18 апреля 2019 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

17 апреля 2019 г.

Последняя проверка

1 апреля 2019 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Другие идентификационные номера исследования

  • FRG2/15-16/032

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

Нет

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. .

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