Cardiac RehabilitationNCT03636724

Evaluation of an E-intervention on MHBC for Chinese Cardiac Patients in Home-based Rehabilitation

A study testing E-intervention in people with Cardiac Rehabilitation and Physical Activity, run by Hong Kong Baptist University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Cardiac Rehabilitation, Physical Activity, Fruit and Vegetable Intake
What is being tested?: E-intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 166 participants
Where: 1 siteChina
Study dates: 31 Jul 2021to 30 Nov 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

Guangdong General Hospital
Guangzhou, Guangdong, 510000

Other trials in China

About this study

Official title: Evaluation of an E-intervention on Multiple Health Behaviour Change for Chinese Cardiac Patients in Home-based Rehabilitation

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.

Read the 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).

Conditions: Cardiac Rehabilitation, Physical Activity, Fruit and Vegetable Intake
Being tested: E-intervention
Keywords: E-health intervention, multiple health behavior change, Health Action Process Approach Model, Cardiac patients
Medical subject headings: Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

E-interventionBehavioural
The 10-week e-health intervention will target HAPA-based social-cognitive variables of PA and FVI. Particularly, Week 1: risk perception and outcome expectancies; Week 2: goal setting; Week 3: development of action plans; Week 4: revision and adjustment of previous action plans; Week 5: development of coping plans; Week 6: revision and adjustment of previous coping plans; Week 7: development of perceived social support; Week 8: revision and adjustment of previous social support. Week 9-10: self-monitoring. Self-efficacy will be a fixed intervention variable involved from week 2 to week 10. Additionally, some behaviour change techniques will be employed in the intervention in order to facilitate the implementation and maintenance of behaviour.

Study groups in NCT03636724
Study group	Role	What they receive
Intervention group	Experimental	Patients will receive the interventions on both PA and FVI simultaneously. Receives: Behavioral: E-intervention
Waiting control group	No intervention	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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change of weekly amount of physical activity (PA)
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.
Measured: From baseline to the 9th week (at the end of intervention) and 3-month follow-up
Change of daily portions of fruit-vegetable intake (FVI)
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.
Measured: From baseline to the 9th week (at the end of intervention) and 3-month follow-up

Secondary outcomes (7)

Change of self-efficacy of PA and FVI
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." Answers will be given on a 5-point Likert scale, ranging from don't agree at all "1" to agree completely "5". The mean value of the total score will be calculated and the higher score denotes to the higher level of self-efficacy.
Measured: From baseline to the 9th week (at the end of intervention) and 3-month follow-up
Change of intention of PA and FVI
The intention for PA will be assessed with the stem "I intend to do for at least 30 minutes a day on minimum 5 days a week or at least 150 minutes a week with…" followed by 3 items such as "… vigorous sport", "…moderate PA" and "…mild PA". The intention for FVI will be measured by the stem " I seriously intend to..." followed by 3 items such as "eat at least 5 servings of fruit and vegetable each day" and "… drink each day at least one glass of fruit or vegetable juice". Answers will be given on a 4-point Likert scale, ranging from not true "1" to exactly true "5". The mean value of the total score will be calculated and the higher score denotes to the higher level of intention.
Measured: From baseline to the 9th week (at the end of intervention) and 3-month follow-up
Change of planning of PA and FVI
Planning indicator will be assessed with 6 items, consisting of action planning and coping planning with 3 items for each dimension. The item of action planning for PA will be asked such as "…which concreted PA I will pursue", for FVI such as "…how I will prepare the food". The items of coping planning for PA will be asked such as "…how I can stay active, even if something happened", for FVI such as "what I can do in difficult situations, in order to remain true to my own resolutions". Answers will be given on a 5-point Likert scale, ranging from totally disagree "1" to totally agree "5". The mean value of the total score will be calculated and the higher score denotes to the higher level of planning.
Measured: 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
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". Answers will be given on a 4-point Likert scale, ranging from totally disagree "1" to totally agree "5". The mean value of the total score will be calculated and the higher score denotes to the higher level of perceived social support.
Measured: From baseline to the 9th week (at the end of intervention) and 3-month follow-up
Change of perceived quality of life: WHO Quality of Life-BREF
This indicator will be assessed by using the short version of the World Health Organisation Quality of Life (WHOQOL-BREF). Respondents will be first 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?". Answers will be given on a 5-point Likert scale, ranging from very poor "1" to very good "5". The mean value of the total score will be calculated and the higher score denotes to the higher level of perceived quality of life.
Measured: From baseline to the 9th week (at the end of intervention) and 3-month follow-up
Change of depression
Level of depression will be assessed with the use of the Center for Epidemiologic Studies Short Depression Scale (CES-D 10). Respondents will be asked with the stem as "In the past week how often I feel …" followed by 10 items such as "…I was bothered by things that usually don't bother me". Answers will be given on a 4-point Likert scale, ranging from rarely or none of the time (less than 1 day) "0" to most or all of the time (5-7 days) "3". The mean value of the total score will be calculated and the higher score denotes to the higher level of depression.
Measured: From baseline to the 9th week (at the end of intervention) and 3-month follow-up
Change of body mass index (BMI)
Participants will be asked to report their body height (in m) and body weight (in kg) for calculating the BMI, using the equation "BMI=weight/ height square".
Measured: From baseline to the 9th week (at the end of intervention) and 3-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Jul 202130 Nov 2023

First posted17 Aug 2018
Study start31 Jul 2021
Primary completion31 Oct 2023
Study completion30 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Cardiac RehabilitationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 166 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03636724
Sponsor's protocol ID: FRG2/17-18/099
Status last verified: Feb 2024
First submitted: 2 Aug 2018
Last updated: 29 Feb 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Duan Y, Liang W, Guo L, Zhan H, Xia C, Ma H, Shang B, Wang Y, Yang M, Cheng S. Effectiveness of a WeChat Mini Program-Based Intervention on Promoting Multiple Health Behavior Changes Among Chinese Patients With Cardiovascular Diseases in Home-Based Rehabilitation: Randomized Controlled Trial. J Med Internet Res. 2025 Jun 3;27:e66249. doi: 10.2196/66249.
PubMed 40460318
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.
PubMed 35392478

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of an E-intervention on Multiple Health Behaviour Change for Chinese Cardiac Patients in Home-based Rehabilitation
ClinicalTrials.gov ID: NCT03636724
Acronym / sponsor ID: FRG2/17-18/099
Conditions: Cardiac Rehabilitation, Physical Activity, Fruit and Vegetable Intake
Keywords: E-health intervention, multiple health behavior change, Health Action Process Approach Model, Cardiac patients
Study type: Interventional
Recruitment status: Completed
Enrolment: 166 participants (actual)
Lead sponsor: Hong Kong Baptist UniversityUniversity, hospital or other
Collaborators: Guangdong Provincial People's Hospital
Study start: 31 Jul 2021 (actual)
Primary completion: 31 Oct 2023 (actual)
Study completion: 30 Nov 2023 (actual)
First posted: 17 Aug 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Intervention group	Experimental	Behavioral: E-interventionPatients will receive the interventions on both PA and FVI simultaneously.
Waiting control group	No intervention	–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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
E-interventionThe 10-week e-health intervention will target HAPA-based social-cognitive variables of PA and FVI. Particularly, Week 1: risk perception and outcome expectancies; Week 2: goal setting; Week 3: development of action plans; Week 4: revision and adjustment of previous action plans; Week 5: development of coping plans; Week 6: revision and adjustment of previous coping plans; Week 7: development of perceived social support; Week 8: revision and adjustment of previous social support. Week 9-10: self-monitoring. Self-efficacy will be a fixed intervention variable involved from week 2 to week 10. Additionally, some behaviour change techniques will be employed in the intervention in order to facilitate the implementation and maintenance of behaviour.	Behavioural	Intervention group

Primary outcome

Change of weekly amount of physical activity (PA)
Time frame: 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)
Time frame: 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.

7 secondary outcomes

Change of self-efficacy of PA and FVI
Time frame: From baseline to the 9th week (at the end of intervention) and 3-month follow-up
Change of intention of PA and FVI
Time frame: From baseline to the 9th week (at the end of intervention) and 3-month follow-up
Change of planning of PA and FVI
Time frame: 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
Time frame: From baseline to the 9th week (at the end of intervention) and 3-month follow-up
Change of perceived quality of life: WHO Quality of Life-BREF
Time frame: From baseline to the 9th week (at the end of intervention) and 3-month follow-up
Change of depression
Time frame: From baseline to the 9th week (at the end of intervention) and 3-month follow-up
Change of body mass index (BMI)
Time frame: From baseline to the 9th week (at the end of intervention) and 3-month follow-up

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
Derived from this study: PubMed 40460318Duan Y, Liang W, Guo L, Zhan H, Xia C, Ma H, Shang B, Wang Y, Yang M, Cheng S. Effectiveness of a WeChat Mini Program-Based Intervention on Promoting Multiple Health Behavior Changes Among Chinese Patients With Cardiovascular Diseases in Home-Based Rehabilitation: Randomized Controlled Trial. J Med Internet Res. 2025 Jun 3;27:e66249. doi: 10.2196/66249.
Derived from this study: PubMed 35392478Duan 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.
Individual participant dataSharing planned: No

Related trials for Cardiac Rehabilitation

Recruiting
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Heart Failure With Preserved Ejection Fraction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Not yet recruiting
King's Theory-Based Multicomponent Interventions in Heart Failure Patient Rehabilitation
Heart Failure, Cardiac Rehabilitation
Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yanping Duan principal investigator

Hong Kong Baptist University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing E-intervention in people with Cardiac Rehabilitation and Physical Activity, run by Hong Kong Baptist University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of weekly amount of physical activity (PA) (time frame: From baseline to the 9th week (at the end of intervention) and 3-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03636724, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.