Authors
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Macquarie University -More
Category
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Primary study
Registry of Trials»Australian New Zealand Clinical Trials Registry
Year
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2026
INTERVENTION: In this randomised controlled trial, participants will receive access to an 6‐week internet‐delivered intervention, the Momentum Course, which provides information and skills for making change to health‐related behaviours and managing emotional wellbeing. The treatment package was designed by Dr Andreea Heriseanu and the eCentreClinic, Macquarie University. The Momentum Course is delivered over 6 weeks, alongside clinical support from a registered mental health clinician. The 6 weeks of the course are followed by a 12 week period where participants engage in additional optional "booster" clinical contact with the study clinician. The Momentum Course consists of: 1. 4 modules, delivered over 6 weeks. Module content is structured around four themes informed by the Health Action Process Approach (HAPA) model of health behaviour change and Cognitive Behaviour Therapy (CBT): (1) Education, (2) Behavioural skills, (3) Cognitive strategies, and (4) Relapse prevention. Modules are delivered online. They are released every week or other week over the 6 weeks, and should take participants 20‐30 minutes to work through. Modules are presented as slide decks consisting of text and static images and can be viewed in the online platform, or downloaded as PDFs. The modules include detailed examples of people with different cardiovascular conditions and/or risk factors to illustrate how to integrate the skills from the Course into everyday life. Modules are accompanied by worksheets which can be downloaded and/or printed as PDF files. Participants are encouraged to engage with these home‐based exercises during the week. 2. Automatic emails that help guide people through the course with frequency of once or twice per week (e.g. reminders when a new module is a CONDITION: Cardiovascular ‐ Coronary heart disease Cardiovascular ‐ Hypertension Cardiovascular ‐ Other cardiovascular diseases cardiovascular disease;cardiovascular risk;depression;anxiety; ; cardiovascular disease ; cardiovascular risk ; depression ; anxiety Diet and Nutrition ‐ Obesity Mental Health ‐ Anxiety Mental Health ‐ Depression Metabolic and Endocrine ‐ Diabetes Metabolic and Endocrine ‐ Other metabolic disorders PRIMARY OUTCOME: Self‐reported diet quality[Diet Quality Tool (DQT) Week 0 (pre‐treatment); Week 7 (post‐treatment); Week 19 (post‐booster period); 3‐month follow‐up; 12 month follow‐up] Self‐reported physical activity[International Physical Activity Questionnaire – Short Form (IPAQ‐SF) ‐ Total activity Week 0 (pre‐treatment); Week 7 (post‐treatment); Week 19 (post‐booster period); 3‐month follow‐up; 12 month follow‐up] SECONDARY OUTCOME: Acceptability[Treatment Satisfaction Questionnaire (a purpose‐built measure to assess the acceptability of online treatment and to measure participants’ satisfaction with treatment and any adverse events) Week 7 (post‐treatment)] Anxiety symptoms ‐ brief[Generalized Anxiety Disorder 2‐Item (GAD‐2) Weekly for Weeks 1‐6 of the intervention] Anxiety[Generalized Anxiety Disorder 7‐Item (GAD‐7) Week 0 (pre‐treatment); Week 7 (post‐treatment); Week 19 (post‐booster period); 3‐month follow‐up; 12 month follow‐up] Barriers of health behaviour change ; [Brief Health Questionnaire (a custom questionnaire assessing self‐rated health, changes in cardiovascular health and in emotional health, changes in health‐related behaviours and barriers and facilitators of health‐related behaviour change) 3‐month follow‐up; 12 month follow‐up] Current health information[Brief Health Questionnaire (a custom questionnaire assessing self‐rated health, changes in cardiovascular health and in emotional health, changes in health‐related behaviours and barriers and facilitators of health‐related behaviour change) 3‐month follow‐up; 12 month follow‐up] Depression symptoms ‐ brief[Patient Health Questionnaire 2‐Item (PHQ‐2) Weekly for Weeks 1‐6 of the intervention] Depression[Patient Health Questionnaire 9‐Item (PHQ‐9) Week 0 (pre‐treatment); Week 7 (post‐treatment); Week 19 (post‐booster period); 3‐month follow‐up; 12 month follow‐up] Diet Quality Index[3 additional diet‐related questions capturing Heart Foundation Position Statement recommendations on diet quality: frequency of fish, processed meat, and red meat consumption per week Week 0 (pre‐treatment); Week 7 (post‐treatment); Week 19 (post‐booster period); 3‐month follow‐up; 12 month follow‐up] Disability[World Health Organization Disability Assessment Schedule 2.0 12‐Item (WHODAS‐2) Week 0 (pre‐treatment); Week 7 (post‐treatment); Week 19 (post‐booster period)] Eating disorder symptomatology[A 4‐item questionnaire previously used in population surveys, based on the gold‐standard instrument for assessing eating disorders, the Eating Disorder Examination Week 0 (pre‐treatment); Week 7 (post‐treatment); Week 19 (post‐booster period)] Facilitators of health behaviour change ; [Brief Health Questionnaire (a custom questionnaire assessing self‐rated health, changes in cardiovascular health and in emotional health, changes in health‐related behaviours and barriers and facilitators of health‐related behaviour change) 3‐month follow‐up; 12 month follow‐up] Habit strength[A single item from the Self‐Report Habit Inde Xassessing automaticity for: diet quality, physical activity and sedentary behaviour Week 0 (pre‐treatment); Week 7 (post‐treatment); Week 19 (post‐booster period); 3‐month follow‐up; 12 month follow‐up] Health behaviour check[A custom 4‐item measure assessing total physical activity, sedentary behaviour, diet quality, and health goal self‐efficacy over the previous week Weekly for Weeks 1‐6 of the intervention] Health behaviour self‐efficacy[Health‐Specific Self‐Efficacy Scales Week 0 (pre‐treatment); Week 7 (post‐treatment); Week 19 (post‐booster period); 3‐month follow‐up; 12 month follow‐up] Objective physical activity (randomly selected sub‐group only)[Axivity AX3 accelerometer Week 0 (pre‐treatment); Week 7 (post‐treatment); Week 19 (post‐booster period)] Objective sedentary behaviour (randomly selected sub‐group only)[Axivity AX3 accelerometer Week 0 (pre‐treatment); Week 7 (post‐treatment); Week 19 (post‐booster period)] Retention[Number and % of participants completing the study measures ‐ obtained from audit of study records Week 0 (pre‐treatment); Week 7 (post‐treatment); Week 19 (post‐booster period); 3‐month follow‐up; 12 month follow‐up] Self‐reported physical activity ‐ moderate to vigorous[International Physical Activity Questionnaire – Short Form (IPAQ‐SF) ‐ Moderate to Vigorous Physical Activity (MVPA) Week 0 (pre‐treatment); Week 7 (post‐treatment); Week 19 (post‐booster period); 3‐month follow‐up; 12 month follow‐up ; ] Self‐reported sedentary behaviour[International Physical Activity Questionnaire – Short Form (IPAQ‐SF) Week 0 (pre‐treatment); Week 7 (post‐treatment); Week 19 (post‐booster period); 3‐month follow‐up; 12 month follow‐up] Sleep difficulties[1. Insomnia Severity Inde X(ISI) 2. Axivity AX3 accelerometer (randomly selected sub‐group only) Week 0 (pre‐treatment); Week 7 (post‐treatment); Week 19 (post‐booster period)] Treatment engagement[Number of course modules completed ‐ obtained from online platform analytics Week 0 (pre‐treatment); Week 7 (post‐treatment)] INCLUSION CRITERIA: (a) Self‐reported stable cardiovascular disease (CVD) or risk factors for CVD (such as diabetes or pre‐diabetes, high blood pressure, high cholesterol, elevated waist circumference or body weight, reduced high density lipoprotein (HDL), elevated low density lipoprotein (LDL), elevated HbA1C, or regularly using tobacco products); (b) Wanting information and skills to help improve health‐promoting behaviours (i.e., diet quality, physical activity, or both); (c) At least mild symptoms of low mood or anxiety (score of >= 1 on the GAD‐2 or PHQ‐2); (d) aged 18 or over; and (e) health being actively managed by GP or medical specialist (e.g. cardiologist).
Epistemonikos ID: ff54c35e097f7e74ffc3cd7842f3190b80f65612
First added on: Sep 12, 2026