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

NCT03636724 | Completed

• 1 other identifier: FRG2/17-18/099
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Rehabilitation; Physical Activity; Fruit and Vegetable Intake

Keywords

E-health intervention; multiple health behavior change; Health Action Process Approach Model; Cardiac patients

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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 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

Other Outcomes (1)

• Social-demographic information

  At the beginning of intervention (Baseline)

Study Arms (2)

Intervention group

EXPERIMENTAL

Patients will receive the interventions on both PA and FVI simultaneously.

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.

Interventions

E-intervention BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hong Kong Baptist University: lead
• Guangdong Provincial People's Hospital: collaborator

Study Sites (1)

Guangdong General Hospital

Guangzhou, Guangdong, 510000, China

Location

Related Publications (1)

• 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.

  PMID: 35392478 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Yanping Duan

  Hong Kong Baptist University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Dr. Duan

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: August 17, 2018
• Study Start: July 31, 2021
• Primary Completion: October 31, 2023
• Study Completion: November 30, 2023
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)