The Effectiveness of a Theory-driven Behavioral Change Intervention on Sedentary Behavior in Individuals With Coronary Heart Disease: A Randomised Controlled Trial
1 other identifier
interventional
232
0 countries
N/A
Brief Summary
The objective of this randomised controlled trial is to examine the effectiveness of a theory-driven behavioural change intervention on total sedentary time (primary outcomes), moderate-to-vigorous physical activity time, intention of behavioural change, future time perception, behavioural prepotency, self-regulation capacity, and exercise capacity in individuals with coronary heart disease. Hypotheses: Compared to the participants in the control group, participants in the intervention group will demonstrate:
- 1.Significantly less total sedentary time
- 2.Significantly improved MVPA time,
- 3.Significantly better intention of behavioural change,
- 4.Significantly higher level of behavioural prepotency,
- 5.Significantly enhanced self-regulation capacity, and
- 6.Significantly greater future time perception
- 7.Significantly better exercise capacity at the immediate post-intervention (T1), the 1-month post-intervention (T2), and the 6-month post-intervention (T3).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2026
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2026
CompletedFirst Posted
Study publicly available on registry
January 22, 2026
CompletedStudy Start
First participant enrolled
April 13, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2026
April 23, 2026
January 1, 2026
7 months
January 14, 2026
April 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total sedentary time
Total sedentary time (per day) will be measured using the ActiGraph accelerometer (ActiGraph,Pensacola, FL), wGT3X-BT (during participants' waking time over 7 consecutive days, including both weekdays and weekends).
Pre-intervention, post-intervention (within 1 week immediately after intervention), and at 1-month and 6-month follow-ups.
Secondary Outcomes (7)
Moderate-to-vigorous physical activity time
Pre-intervention, post-intervention (within 1 week immediately after intervention), and at 1-month and 6-month follow-ups.
Self-regulation capacity
Pre-intervention, post-intervention (within 1 week immediately after intervention), and at 1-month and 6-month follow-ups.
Behavioural prepotency
Pre-intervention, post-intervention (within 1 week immediately after intervention), and at 1-month and 6-month follow-ups.
Future time perception
Pre-intervention, post-intervention (within 1 week immediately after intervention), and at 1-month and 6-month follow-ups.
Intention of behavioural change
Pre-intervention, post-intervention (within 1 week immediately after intervention), and at 1-month and 6-month follow-ups.
- +2 more secondary outcomes
Study Arms (2)
Intervention group
EXPERIMENTALIn addition to the usual care, which is the same as the control group, participants allocated to the intervention group will receive a 12-week theory-driven behavioural change intervention. The intervention is structured into eight individual sessions, including four face-to-face sessions (45 minutes each) and four telephone sessions (20 minutes each).
Attention controlled Group
ACTIVE COMPARATORParticipants in the control group will continue to have the usual care and education sessions, consisting of information about healthy lifestyles, except physical activity and sedentary behaviour.
Interventions
A theory-driven behavioural change intervention is validated by an expert panel including professionals from various fields, such as nurse consultants, a specialty nurse in cardiology, an experienced registered nurse from a cardiac rehabilitation center in a regional hospital, a physiotherapist, and academia, focusing on strengthening intention to change (connected beliefs and temporal valuations), behavioral prepotency, and enhancing the self-regulatory capacity, as guided by the Temporal Self-Regulation Theory, and supplemented with a intervention booklet. The intervention is developed and facilitated by a registered nurse (principal investigator).
Participants in the attention control group will participate in education sessions consisting of information about healthy lifestyles, except physical activity and sedentary behaviour. Activities match the time and attention dedicated by the intervention group. Activities are designed to have no impact on sedentary behaviour and physical activity.
Eligibility Criteria
You may qualify if:
- Adult 18 years old and above
- Diagnosed with coronary heart disease within one year
- Engaged in MVPA less than 150 minutes per week and a minimum of 8 hours total sedentary time per day, both assessed using the Global Physical Activity Questionnaire
- Able to communicate in Cantonese
- Obtained medical clearance for physical activity (no medical contraindications to exercise, including walking)
- Being able to understand and give informed consent
- Having telephone access, text messaging services or WhatsApp
You may not qualify if:
- Cannot perform brisk walking exercise
- Unable to perform PA independently
- Cognitive impairments, as indicated by an abbreviated mental test score of less than 7
- Currently enrolled in another clinical trial focusing on limiting SB with/without enhancing PA
- Doctor-diagnosed psychiatric illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elaine Yi Ning Miu, MSc
Chinese University of Hong Kong
- STUDY DIRECTOR
Ho Yu Cheng, PhD
Chinese University of Hong Kong
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The study employs single masking, where only the outcome assessor is blinded. Due to the nature of the interventions, masking the participants and intervention providers is not feasible.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Candidate, Registered Nurse
Study Record Dates
First Submitted
January 14, 2026
First Posted
January 22, 2026
Study Start
April 13, 2026
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
October 31, 2026
Last Updated
April 23, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share
The research team does not have plans to proactively or automatically make the individual participant data (IPD) from this study available to other researchers. However, the IPD may be shared upon request, provided that the requesting party has a valid scientific or medical rationale and obtains the necessary approval from the research team. Any requests for access to the study's IPD will be reviewed on a case-by-case basis by the research team. Factors that will be considered in evaluating such requests include: Scientific merit and validity of the proposed use of the data Qualifications and track record of the requesting researcher or research team Alignment with the original study objectives and participants' consent