A micro randomised trial (MRT) to test the effects of app-based motivational messages on physical activity and heart rate.

Not Applicable

Recruiting

• Conditions: Sedentary lifestyle; Autonomic dysfunction; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12622000731796
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-20
• Last Update Posted: 27 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

1.Intervention group participants from the LIVEPLUS study (ANZCTR registration: ACTRN12620001151921).
2.Adults who can competently use a smartphone (running iOS or Android)
3.Presence of Low attenuation plaque on Coronary Computed Tomography Angiography
4.18-80 years of age
5.BMI greater than or equal to 22.0 kg/m2
6.Have no contraindications for the LIVEPLUS study
7.Able to give full informed consent

Exclusion Criteria

People from the Control group participants from the LIVEPLUS study (ANZCTR registration: ACTRN12620001151921) will be excluded.
Additional exclusion criteria for the parent LIVEPLUS study are as follows:
1. History or clinical manifestation of any other significant metabolic, hematologic, pulmonary, cardio- vascular, gastrointestinal, neurologic, immune, hepatic, renal, urologic disorders, or cancer that, in opinion of the investigator, would make the candidate ineligible for the study
2.Non-MRI-compatible implanted devices or implants
3.Estimated glomerular filtration rate (eGFR) less than 30mL/kg/1.73m2
4.Inability to exercise via supine ergometer
5.Claustrophobia
6.Contraindications for adenosine: Sinus node disease (e.g. sick sinus syndrome, symptomatic sinus bradycardia), second- or third- degree heart blocks, unstable angina, bronchospasm (e.g. asthma), heart transplant recipient, history of seizure disorder
7.Contraindications for glyceryl trinitrate: Known nitrate hypersensitivity, severe anaemia, severe aortic or mitral stenosis, hypotension defined as resting systolic blood pressure equal to 89 mmHg.
8.Not suitable for CT coronary angiography due to contraindications
9.Psychiatric or behavioural problems (history of drug and alcohol abuse, eating disorder)
10.Breast feeding or pregnant women, or those intending to become pregnant before the scheduled end of the intervention
11.Concurrent participation in any other interventional study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of steps walked within 180 minutes after messages are sent at each decision-making time point (proximal) as determined from Fitbit device data.[ Cumulative data will be assessed at the end of months 6 and 12 of the intervention.]

Secondary Outcome Measures

Name	Time	Method
Duration of time spent engaged in physical activity within 180 minutes of receiving the message (proximal) as determined from Fitbit device data.[ Cumulative data will be assessed at the end of months 6 and 12 of the intervention.];Change in heart rate within the next 180 minutes after intervention (proximal) as determined from Fitbit device data.[ Cumulative data will be assessed at the end of months 6 and 12 of the intervention.];Change values of resting heart rate for both Phases 1 and 2 (distal) as determined from Fitbit device data.[ Cumulative data will be assessed at the end of months 6 and 12 of the intervention.];Total number of steps walked during both Phases 1 and 2 periods (distal) as determined from Fitbit device data.[ Cumulative data will be assessed at the end of months 6 and 12 of the intervention.]