Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07357961
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).
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.
Study:
NCT07357961
Study Brief:
Protocol Section:
NCT07357961