ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12626001005347

Ethics application status

Approved

Date submitted

30/07/2026

Date registered

14/08/2026

Date last updated

14/08/2026

Date data sharing statement initially provided

14/08/2026

Type of registration

Prospectively registered

Titles & IDs

Public title

The Momentum Course: A randomised controlled trial of a remotely-delivered health behaviour change intervention for adults with cardiovascular disease or risk and depression or anxiety symptoms

Scientific title

The Momentum Course: A randomised controlled trial of a remotely-delivered health behaviour change intervention for adults with cardiovascular disease or risk and depression or anxiety symptoms

Additional trial identifiers [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Momentum Course RCT

Related trial records

ACTRN12625001016426 - Momentum Course feasibility pilot trial

Health condition

Health condition(s) studied:

cardiovascular disease

cardiovascular risk

depression

anxiety

Condition category

Condition code

Cardiovascular

Coronary heart disease

Cardiovascular

Hypertension

Cardiovascular

Other cardiovascular diseases

Diet and Nutrition

Obesity

Metabolic and Endocrine

Diabetes

Metabolic and Endocrine

Other metabolic disorders

Mental Health

Anxiety

Mental Health

Depression

Intervention/exposure

Study type

Interventional

Description of the intervention or exposure

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 available; congratulatory messages once a module has been completed; brief messages that reinforce the core concepts of the modules, and e-mails inviting contact and encouraging engagement).

3. Additional Resources (articles in PDF format) providing information about different problems people often struggle with, including managing sleep, managing unhelpful eating patterns, etc.

4. All participants are also provided access to brief, up to weekly support from a registered mental health clinician alongside the intervention, which is provided either via telephone or a secure messaging system. The clinician's role is to support people through the intervention, help tailor the intervention to their particular difficulties, encourage skills practice and answer questions. Clinician support is provided based on patient preference, and can be proactively scheduled (e.g., weekly appointments) or on request and as needed. In the 12-week period following the course, participants have the option of continuing to engage in “booster” clinical contact with the trial clinician, with the purpose of encouraging skills practice in the longer term. This contact is similar to the support provided during the course (i.e. brief contact via telephone or secure messaging system).

Adherence to the intervention is monitored via the study's secure web platform, which records information such as the number of participant logins, modules accessed; time spent completing each module; and number of downloads of additional resources.

Accelerometer data collection
All participants will be asked at initial assessment if they would be willing to use a wrist-worn accelerometer, should they be selected for this study sub-component (noting that this does not represent an inclusion/exclusion criterion for the RCT). Of those willing, an equal number will be randomised to accelerometer wear within the treatment and control group. This step is necessary given that only a small number of accelerometers are available. Participants will be asked to wear the devices for 7 continuous days at pre-treatment, post-treatment, and 12-week follow-up. The devices are research-grade triaxial Axivity Ax3 accelerometers (https://axivity.com/product/ax3) housed within a silicone wrist band. These devices do not have a display, and in the current research they will be used solely for data logging purposes. Adherence will be monitored via days of valid wear (>=3, including at least one day of the weekend, similar to the UK Biobank study which also used AX3 devices).

Intervention code [1]

Behaviour

Intervention code [2]

Treatment: Other

Intervention code [3]

Lifestyle

Description of the comparator or control

There will be a Treatment-as-usual Waitlist Control (TAU-WLC) group which will receive full access to the intervention after the Treatment Group finishes the Momentum Course and the 12-week "booster" contact period. Participants in the TAU-WLC group will continue to receive their normal treatment and care from their regular health practitioners and general use of the health-care system. Additionally, they will be offered standard information obtained from the Australian Government Department of Health, Disability and Ageing on the current national physical activity and dietary guidelines. After the Treatment Group has finished the 12-week follow-up questionnaires (i.e. at the end of the 12 week "booster" period), participants in the TAU-WLC group will be able to start receiving the intervention.

Control group

Active

Outcomes

Primary outcome [1]

Self-reported physical activity

Timepoint [1]

Week 0 (pre-treatment); Week 7 (post-treatment); Week 19 (post-booster period); 3-month follow-up; 12 month follow-up

Primary outcome [2]

Self-reported diet quality

Timepoint [2]

Week 0 (pre-treatment); Week 7 (post-treatment); Week 19 (post-booster period); 3-month follow-up; 12 month follow-up

Secondary outcome [1]

Depression

Timepoint [1]

Week 0 (pre-treatment); Week 7 (post-treatment); Week 19 (post-booster period); 3-month follow-up; 12 month follow-up

Secondary outcome [2]

Anxiety

Timepoint [2]

Week 0 (pre-treatment); Week 7 (post-treatment); Week 19 (post-booster period); 3-month follow-up; 12 month follow-up

Secondary outcome [3]

Diet Quality Index

Timepoint [3]

Week 0 (pre-treatment); Week 7 (post-treatment); Week 19 (post-booster period); 3-month follow-up; 12 month follow-up

Secondary outcome [4]

Self-reported sedentary behaviour

Timepoint [4]

Week 0 (pre-treatment); Week 7 (post-treatment); Week 19 (post-booster period); 3-month follow-up; 12 month follow-up

Secondary outcome [5]

Sleep difficulties

Timepoint [5]

Week 0 (pre-treatment); Week 7 (post-treatment); Week 19 (post-booster period)

Secondary outcome [6]

Objective physical activity (randomly selected sub-group only)

Timepoint [6]

Week 0 (pre-treatment); Week 7 (post-treatment); Week 19 (post-booster period)

Secondary outcome [7]

Objective sedentary behaviour (randomly selected sub-group only)

Timepoint [7]

Week 0 (pre-treatment); Week 7 (post-treatment); Week 19 (post-booster period)

Secondary outcome [8]

Eating disorder symptomatology

Timepoint [8]

Week 0 (pre-treatment); Week 7 (post-treatment); Week 19 (post-booster period)

Secondary outcome [9]

Depression symptoms - brief

Timepoint [9]

Weekly for Weeks 1-6 of the intervention

Secondary outcome [10]

Anxiety symptoms - brief

Timepoint [10]

Weekly for Weeks 1-6 of the intervention

Secondary outcome [11]

Health behaviour self-efficacy

Timepoint [11]

Week 0 (pre-treatment); Week 7 (post-treatment); Week 19 (post-booster period); 3-month follow-up; 12 month follow-up

Secondary outcome [12]

Health behaviour check

Timepoint [12]

Weekly for Weeks 1-6 of the intervention

Secondary outcome [13]

Habit strength

Timepoint [13]

Week 0 (pre-treatment); Week 7 (post-treatment); Week 19 (post-booster period); 3-month follow-up; 12 month follow-up

Secondary outcome [14]

Disability

Timepoint [14]

Week 0 (pre-treatment); Week 7 (post-treatment); Week 19 (post-booster period)

Secondary outcome [15]

Treatment engagement

Timepoint [15]

Week 0 (pre-treatment); Week 7 (post-treatment)

Secondary outcome [16]

Retention

Timepoint [16]

Week 0 (pre-treatment); Week 7 (post-treatment); Week 19 (post-booster period); 3-month follow-up; 12 month follow-up

Secondary outcome [17]

Acceptability

Timepoint [17]

Week 7 (post-treatment)

Secondary outcome [18]

Current health information

Timepoint [18]

3-month follow-up; 12 month follow-up

Secondary outcome [19]

Barriers of health behaviour change

Timepoint [19]

3-month follow-up; 12 month follow-up

Secondary outcome [20]

Facilitators of health behaviour change

Timepoint [20]

3-month follow-up; 12 month follow-up

Secondary outcome [21]

Self-reported physical activity - moderate to vigorous

Timepoint [21]

Week 0 (pre-treatment); Week 7 (post-treatment); Week 19 (post-booster period); 3-month follow-up; 12 month follow-up

Eligibility

Key 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).

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Healthy volunteers

Key exclusion criteria

(a) Current severe medical or psychiatric disorder that requires immediate treatment (e.g. current mania or psychosis, actively suicidal or unable to keep themselves safe, medical condition requiring immediate surgery or other invasive treatment);
(b) Contraindication to exercise or diet modification;
(c) Not living in Australia;
(d) Serious cognitive impairment that may impact upon ability to participate in the trial;
(e) Unable to read and understand English, and
(f) No access to a computer and the internet.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

The randomisation sequence will be generated prior to enrolment of the first participant, which ensures that the research team are unable to affect group allocation. Randomisation will also be conducted such that study personnel who determine eligibility and enrol participants are blind to which treatment allocation participants will be assigned to (i.e., allocation concealment). Concealment occurs through the use of locked and concealed cells in a spreadsheet, which recruitment staff are required to open serially.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Randomisation will be stratified by participant behavioural goal at baseline (i.e., increasing physical activity, diet quality, or both), and by the level of performance of health-related behaviours at assessment. Randomisation within these strata will occur with blocks of 2-6 in size using a computer-generated randomisation sequence (using www.random.org) by an independent researcher not involved in the recruitment of participants.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Data analysis
All analyses will be carried out using conservative intention-to-treat principles.

Primary analyses will compare the change in primary outcome measures across time between groups, with pre-treatment to 12 weeks post-treatment as the primary endpoint. To ensure outcome relevance, these analyses will be conducted for sub-groups of participants whereby the primary outcomes reflect participant goals and are clinically relevant. That is, outcomes will be analysed for participants where they are working on the outcome (e.g., increasing physical activity) and their baseline level could be improved upon (e.g., their activity levels were low or moderate).

Overall group analyses (i.e., overall treatment group vs overall control group) will also be conducted as secondary/supplementary analyses. Subgroup analyses are also expected to be carried out to explore the efficacy and acceptability of the intervention based on participants' mental health symptom severity and other relevant characteristics. Proportions meeting criteria for clinical improvement and changes in severity ranges (e.g. >=30% / >=50% change from baseline, changes from lower to higher health behaviour categories from baseline) will also be examined.

Analyses for primary and secondary outcomes will be conducted using generalised estimation equation (GEE) models. Multiple imputation will be used to handle missing cases.

Sample size and power
In line with clinical guidelines for sample size estimation, pilot data from a previous clinical trial of this intervention and treatment effects from the literature were used to determine that sample of 80 in each arm (N = 160) is sufficiently powered to detect differences in the rate of pre-post primary outcomes of approximately (1) 15% for diet quality and (2) 40% for physical activity between the groups. This estimation was calculated under commonly used error thresholds with alpha set at 0.05 and power set at 0.80. Utilising an attrition rate estimation of 10%, a final larger sample of 88:88 (N = 176) was decided.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

17/08/2026

Actual

Date of last participant enrolment

Anticipated

5/04/2027

Actual

Date of last data collection

Anticipated

20/08/2028

Actual

Sample size

Target

176

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

Macquarie University

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

Macquarie University

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Macquarie University Human Research Ethics Committee Medical Sciences

Ethics committee address [1]

https://www.mq.edu.au/research/ethics-integrity-and-policies/ethics/human-ethics

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/06/2026

Approval date [1]

16/07/2026

Ethics approval number [1]

520262100568913 / 21005

Summary

Brief summary

The study is testing a new internet-based health program that can be done from home. The aim is to find out if it helps improve important healthy actions (such as diet and exercise), as well as emotional wellbeing, in adults who have heart or blood vessel conditions or are at risk for these, and who also have symptoms of depression or anxiety. The program is psychologically-informed and designed to teach skills for setting goals, maintaining healthy actions in the long term, and overcoming common challenges.

Trial website

https://www.ecentreclinic.org/momentum-course

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Andreea Heriseanu

Address

School of Psychological Sciences, Australian Hearing Hub, Level 2, 16 University Avenue, Macquarie University NSW 2109

Country

Australia

Phone

+61 2 9850 9656

Fax

[email protected]

Contact person for public queries

Name

Andreea Heriseanu

Address

School of Psychological Sciences, Australian Hearing Hub, Level 2, 16 University Avenue, Macquarie University NSW 2109

Country

Australia

Phone

+61 2 9850 9656

Fax

[email protected]

Contact person for scientific queries

Name

Andreea Heriseanu

Address

School of Psychological Sciences, Australian Hearing Hub, Level 2, 16 University Avenue, Macquarie University NSW 2109

Country

Australia

Phone

+61 2 9850 9656

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor

What individual participant data might be shared?

• De-identified individual participant data:
• All outcomes data
• Published results
• Primary outcome(s)
• Safety data

What types of analyses could be done with individual participant data?

• Systematic reviews and meta-analyses
• Studies testing whether findings can be repeated or confirmed

When can requests for individual participant data be made (start and end dates)?

From:
At the end of the study
To:
No end date

Where can requests to access individual participant data be made, or data be obtained directly?

• Email of trial custodian, sponsor or committee: Data will be made available following formal request via email to the chief investigator ([email protected]) using a mechanism that is satisfactory for the Macquarie University Human Research Ethics Committee (providing governance for the current research) and any other Human Research Ethics Committees involved.

Are there extra considerations when requesting access to individual participant data?

Yes: Costs, timelines, data safety and institutional approval.

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically