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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • A theory-driven behavioural change intervention

    Behavioral

    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).

  • Attentive control group

    Behavioral

    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.

Treatment groups

232 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Attention controlled GroupActive comparator 1 intervention

Trial outcomes

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).

Time frame
Pre-intervention, post-intervention (within 1 week immediately after intervention), and at 1-month and 6-month follow-ups.

Secondary outcomes

1

Moderate-to-vigorous physical activity time

Moderate-to-vigorous physical activity time (per week) will be measured using the ActiGraph accelerometer (ActiGraph, Pensacola, FL), wGT3X-BT (during participants' waking time over seven consecutive days, including both weekdays and weekends).

Time frame
Pre-intervention, post-intervention (within 1 week immediately after intervention), and at 1-month and 6-month follow-ups.
2

Self-regulation capacity

Self-regulation capacity will be measured using the Chinese version of the Brief Self-Control Scale (BSCS).

Time frame
Pre-intervention, post-intervention (within 1 week immediately after intervention), and at 1-month and 6-month follow-ups.
3

Behavioural prepotency

Behavioural prepotency (on both MVPA and SB) will be measured using the Chinese version of the Self-Reported Behavioural Automaticity Index (SRBAI).

Time frame
Pre-intervention, post-intervention (within 1 week immediately after intervention), and at 1-month and 6-month follow-ups.
4

Future time perception

Future time perception will be measured using the Chinese version of the Consideration of Future Consequences Scale (CFCS-14).

Time frame
Pre-intervention, post-intervention (within 1 week immediately after intervention), and at 1-month and 6-month follow-ups.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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