NCT07357961

The Effectiveness of a Theory-driven Behavioral Change Intervention on Sedentary Behavior in Individuals With Coronary Heart Disease: A Randomised Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 232 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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). Participants will: Participants in the intervention group will participate in a theory-driven behavioural change intervention over three months, comprising four individual face-to-face sessions (45 minutes each) and four individual telephone sessions (20 minutes each), along with the usual care. Participants in the attention control group will continue to have the usual care, which includes regular follow-up at the cardiac clinic. Education sessions, consisting of information about healthy lifestyles, except physical activity and sedentary behaviour, with the same schedule as the intervention group, will be provided to account for potential attention effects from contacts.

Detailed description

Coronary heart disease is a worldwide health problem and a major contributor to disability, with a high prevalence of 315 million cases globally in 2022. Promoting movement behaviours, which are characterised by having an adequate amount of physical activity and replacing sedentary behaviour with physical activity of all intensities, is beneficial for cardiometabolic health and thus secondary prevention. However, reviews of interventional studies indicate that currently available non-pharmacological interventions are effective in increasing the amount of physical activity, yet limited attention is given to the reduction of sedentary behaviour in current cardiac rehabilitation. Therefore, it is imperative to develop an non-pharmacological intervention targeting sedentary behaviour for adults with coronary heart disease based on the synthesised scientific evidence. The design of the theory-driven behavioural change intervention is based on the findings of our published systematic review and the implications of the qualitative study. This randomised controlled trial evaluate a theory-driven behavioural change intervention for individuals with coronary heart disease. The objective of the study aims to examine the effectiveness of the intervention in reducing total sedentary time (primary outcome) and improving MVPA, behavioural intentions, future time perception, behavioural prepotency, self-regulation capacity, and exercise capacity in a larger sample.

Conditions

• Coronary Heart Disease (CHD)

Interventions

Type	Name	Description
BEHAVIORAL	A theory-driven behavioural change intervention	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).
BEHAVIORAL	Attentive control group	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.

Timeline

• Start date: 2026-04-13
• Primary completion: 2026-10-31
• Completion: 2026-10-31
• First posted: 2026-01-22
• Last updated: 2026-04-07