Clinical trial NCT03636724: Evaluation of an E-intervention on MHBC for Chinese Cardiac Patients in Home-based Rehabilitation
Official title: Evaluation of an E-intervention on Multiple Health Behaviour Change for Chinese Cardiac Patients in Home-based Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Rehabilitation
Physical Activity
Fruit and Vegetable Intake
Keywords: E-health intervention
multiple health behavior change
Health Action Process Approach Model
Cardiac patients
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
Collaborators: name: Guangdong Provincial People's Hospital
First posted: 2018-08-17
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change of weekly amount of physical activity (PA)
timeFrame: From baseline to the 9th week (at the end of intervention) and 3-month follow-up
measure: Change of daily portions of fruit-vegetable intake (FVI)
timeFrame: From baseline to the 9th week (at the end of intervention) and 3-month follow-up
Secondary outcomes:
measure: Change of self-efficacy of PA and FVI
timeFrame: From baseline to the 9th week (at the end of intervention) and 3-month follow-up
measure: Change of intention of PA and FVI
timeFrame: From baseline to the 9th week (at the end of intervention) and 3-month follow-up
measure: Change of planning of PA and FVI
timeFrame: From baseline to the 9th week (at the end of intervention) and 3-month follow-up
measure: Change of perceived social support of PA and FVI
timeFrame: From baseline to the 9th week (at the end of intervention) and 3-month follow-up
measure: Change of perceived quality of life: WHO Quality of Life-BREF
timeFrame: From baseline to the 9th week (at the end of intervention) and 3-month follow-up
measure: Change of depression
timeFrame: From baseline to the 9th week (at the end of intervention) and 3-month follow-up
measure: Change of body mass index (BMI)
timeFrame: From baseline to the 9th week (at the end of intervention) and 3-month follow-up
Other outcomes:
measure: Social-demographic information
timeFrame: At the beginning of intervention (Baseline)
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
Study officials:
affiliation: Hong Kong Baptist University
name: Yanping Duan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Duan Y, Li X, Guo L, Liang W, Shang B, Lippke S. A WeChat Mini Program-Based Intervention for Physical Activity, Fruit and Vegetable Consumption Among Chinese Cardiovascular Patients in Home-Based Rehabilitation: A Study Protocol. Front Public Health. 2022 Mar 22;10:739100. doi: 10.3389/fpubh.2022.739100. eCollection 2022.