Evaluation of an E-intervention on Multiple Health Behaviour Change for Chinese Cardiac Patients in Home-based Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Change of weekly amount of physical activity (PA)
研究概览
简要总结
By using the Health Action Process Approach (HAPA) model as a theoretical backdrop, the proposed study aims to provide a 10-week e-health learning strategies for Chinese cardiac patients, with which they can follow at home after rehabilitation discharge. The current study will examine whether the cardiac rehabilitation patients in intervention group would increase their physical activity (PA) level and fruit-vegetable intake (FVI), improve the social-cognitive variables of PA and FVI, and enhance mental health outcomes in comparison with control condition; and whether the social-cognitive variables would mediate the association between intervention and adopting a healthy lifestyle. The study findings may contribute to the current multiple health behaviour intervention research and support Chinese cardiac patients to maintain rehabilitation outcomes and cultivate a healthy lifestyle.
详细描述
For the main study, the sample size will be estimated by using G*Power 3.1 software with MANOVA of repeated measures approach. For achieving a medium effect size of 0.25 (Duan et al., 2017), with a power (1-β) of 0.8 and an alpha of 0.05, the total sample size will be 116. Assuming a dropout rate of approximately 30%, a total of 166 participants will be required for the study evaluation.
All data will be analyzed by using SPSS 23.0 software. Independent samples t-tests and Chi2-tests will be adopted to examine the characteristics of drop out and compare the differences of baseline data at T1. Statistical significance will be set at 5% level (two-tailed). The intervention effects on behavioural, social-cognitive and mental health status-related indicators will be tested by conducting the multivariate analysis of variance (MANOVA) with repeated measures, with time (T1, T2 and T3) as the with-in subjects factor and group (IG and CG) as the between-subjects factor. Missing data will be imputed within each measurement point in time using the Expectation-Maximization (EM) method. Furthermore, the intervention effect on healthy lifestyle indicator will be examined by performing a multinomial logistic regression model. The multiple-mediator model will be conducted to test the mediation effects with the use of SPSS macro (Preacher & Hayes, 2008).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •no restriction of physical mobility under the cardiac function at entry
- •no restriction of relevant diseases such as diabetes or fruit allergies
- •As the study involves an online website and mobile phone SMS, only participants with access to the Internet via mobile phone will be enrolled
排除标准
- •have restrictions of physical mobility under the cardiac function at entry
- •have restrictions of relevant diseases such as diabetes or fruit allergies
- •cannot use the Internet and mobile phone
研究组 & 干预措施
Intervention group
Patients will receive the interventions on both PA and FVI simultaneously.
干预措施: E-intervention (Behavioral)
Waiting control group
Patients will not receive any supportive interventions on PA or FVI during the intervention period but will be provided with the same intervention at follow-up six-month after the intervention.
结局指标
主要结局
Change of weekly amount of physical activity (PA)
时间窗: From baseline to the 9th week (at the end of intervention) and 3-month follow-up
The level of PA will be measured through the short Chinese version of the International Physical Activity Questionnaire (IPAQ-C) questionnaire. Participants will be asked to estimate the number of days and hours spent for vigorous, moderate and walking activities during the past week. The total physical activity score for each participants is the sum of frequency per week, multiplied by time-consumption (minutes) each time.
Change of daily portions of fruit-vegetable intake (FVI)
时间窗: From baseline to the 9th week (at the end of intervention) and 3-month follow-up
Fruit and vegetable intake (FVI) will be measured with four items, including fruit or vegetable juice, fruit, cooked or steamed vegetables, and raw vegetables. Respondents will be asked to count the number of portions of fruit and vegetables they consumed on average during a typical day. Each item has 11 options for the number of portions such as 0, 0.5, 1, 1.5, 2, 2.5, ..., and 5 or above. The total portion of fruit and vegetable consumption is the sum of each item.
次要结局
- Change of perceived quality of life: WHO Quality of Life-BREF(From baseline to the 9th week (at the end of intervention) and 3-month follow-up)
- Change of body mass index (BMI)(From baseline to the 9th week (at the end of intervention) and 3-month follow-up)
- Change of self-efficacy of PA and FVI(From baseline to the 9th week (at the end of intervention) and 3-month follow-up)
- Change of intention of PA and FVI(From baseline to the 9th week (at the end of intervention) and 3-month follow-up)
- Change of planning of PA and FVI(From baseline to the 9th week (at the end of intervention) and 3-month follow-up)
- Change of perceived social support of PA and FVI(From baseline to the 9th week (at the end of intervention) and 3-month follow-up)
- Change of depression(From baseline to the 9th week (at the end of intervention) and 3-month follow-up)
研究者
Yanping DUAN
Assistant Professor, Dr. Duan
Hong Kong Baptist University