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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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-
• Поведенческое 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.

Первичные конечные точки

• Total sedentary time [Срок оценки: Pre-intervention, post-intervention (within 1 week immediately after intervention), and at 1-month and 6-month follow-ups.]

Вторичные конечные точки (7)

• Moderate-to-vigorous physical activity time [Срок оценки: Pre-intervention, post-intervention (within 1 week immediately after intervention), and at 1-month and 6-month follow-ups.]
• Self-regulation capacity [Срок оценки: Pre-intervention, post-intervention (within 1 week immediately after intervention), and at 1-month and 6-month follow-ups.]
• Behavioural prepotency [Срок оценки: Pre-intervention, post-intervention (within 1 week immediately after intervention), and at 1-month and 6-month follow-ups.]
• Future time perception [Срок оценки: Pre-intervention, post-intervention (within 1 week immediately after intervention), and at 1-month and 6-month follow-ups.]
• Intention of behavioural change [Срок оценки: Pre-intervention, post-intervention (within 1 week immediately after intervention), and at 1-month and 6-month follow-ups.]
• Functional exercise capacity [Срок оценки: Pre-intervention, post-intervention (within 1 week immediately after intervention), and at 1-month and 6-month follow-ups.]
• Waist circumference [Срок оценки: Pre-intervention, post-intervention (within 1 week immediately after intervention), and at 1-month and 6-month follow-ups.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07357961 · CREC_2025.458

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗