HAPPYLondon: Heart Attack Prevention Programme for You (HAPPY) London

• Sponsor: Queen Mary University of London (Other)
• Overall Status: Completed
• CT.gov ID: NCT01911910
• Collaborator: Barts & The London NHS Trust (Other)
• Enrollment: 402
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 17.5

Study Details

Study Description

Brief Summary

Diseases of the heart and blood vessels, such as heart attacks and strokes, are very common and can lead to severe disability or death. Changes in the body leading to heart attacks and strokes usually develop over decades as a result of smoking, diet, and lack of exercise, obesity, diabetes and high blood pressure. Changes in lifestyle and diet can significantly reduce the risk of heart diseases. General Practitioners invite 40 to 74 year-olds who have no known heart disease to take part in the NHS Health Check, which measures each person's individual risk of developing a heart attack or stroke and encourages them in a face-to-face meeting to take part in programmes to help them to give up smoking, lose weight etc. where necessary. In this new clinical trial the investigators will test whether computer-tailored electronic (e)-coaching via email and the internet can help people make the necessary changes in their lifestyle to reduce the risk of heart attacks and strokes.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease	Behavioral: Electronic coaching plus standard care	N/A

Detailed Description

Heart Attack Prevention Programme for You London (HAPPY London) will be conducted as a randomised controlled trial comparing the use of tailored e-coaching in addition to the standard of care vs. standard care alone. Standard care is defined as the care that would be offered by the NHS Health Check programme through the NHS primary care. We will use a range of established and novel cardiovascular markers to determine the clinical and cost effectiveness of e-coaching and gain pathophysiological insight into how lifestyle modifications affect the cardiovascular system. These measures include cardiovascular magnetic resonance imaging (CMR), aortic stiffness parameters, vascular ultrasound and other biomarkers of CV disease risk.

Intervention

The HAPPY London web-based tool will provide the participant with an individualised score for their lifestyle and 10 year CV risk score, based on the modified Framingham score and the UK specific QRisk Score, and provide tailored advice and education on the suboptimal factors. Ideal targets will be set and the information will be updated at 3 and 6 months allowing the participant to view their progress. Weekly emails with brief health and lifestyle advice will be sent to encourage healthier behaviour based on clinical studies or topical issues in the media. Links to social networks, such as Facebook posting and the ability to allow chosen 'buddies' from family or friends to view their progress will aim to further encourage healthier behaviour.

The study involves the recruitment of 400 adults between the age of 40 and 74 years who have a moderate to high 10-year CV risk score (Estimated 10 year CV risk >10%). Half of the study group will receive use of the e-coaching in addition to standard care allocated randomly stratified according to either moderate (QRisk between 10 and 20%) or high risk (QRisk more than or equal to 20%). The initial screening will take place on the www.happylondon.info web-based 'mini-check' questionnaire. Potential participants will then be seen at a physical screening visit to confirm eligibility. 3 subsequent visits will take place over 6 months; baseline, 3 month and 6 month follow up. A subgroup of the study population (65 from each intervention arm thus totalling 130 participants ) will also have a baseline and follow up cardiovascular magnetic resonance (CMR) imaging. Assessment will be performed using a variety of measures through questionnaires, blood pressure (BP) checks, blood tests, ultrasound scans, oscillometric method to assess pulse wave velocity and pulse wave analysis and CMR multi-parametric scanning.

The primary aim of this study is to assess the clinical effectiveness of individualised, continuous electronic (e-) coaching to support a healthier lifestyle as a primary prevention tool to reduce the CV risk and improve the quality of life in asymptomatic individuals with intermediate to high 10 year CV risk.

Other questions that we aim to answer are:

1. Is computer-tailored e-coaching cost-effective in the short-term (clinical trial period) and during the long-term (decision analysis modelling)

2. What are the associations of personality traits, economic preferences, and sociocultural factors with the achieved lifestyle modifications and changes in the cardiovascular phenotype?

3. What is the relationship between changes observed in markers derived from our multi-parametric cardiovascular magnetic resonance imaging protocols following lifestyle changes?

4. How frequent are silent myocardial infarctions in a typical NHS Health Check population?

5. Do treatment effects differ between ethnic groups?

Study Design

• Study Type: Interventional
• Actual Enrollment: 402 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Heart Attack Prevention Programme for You (HAPPY) London
• Study Start Date: Jun 1, 2013
• Actual Primary Completion Date: May 1, 2015
• Actual Study Completion Date: May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Standard care Usual care that would be provided by the NHS Health Check or equivalent.
Experimental: Electronic coaching plus standard care Tailored coaching for participants randomised to use the HAPPY e-coaching tool. Access to lifestyle and heart health scores and personalised advice to improve suboptimal behaviour.	Behavioral: Electronic coaching plus standard care; The HAPPY London web-based tool will provide the participant with an individualised score for their lifestyle and 10 year CV risk score, based mainly on the modified Framingham score, and provide tailored advice and education on the suboptimal factors. Ideal targets will be set and the information will be updated at 3 and 6 months allowing the participant to view their progress. Weekly emails with brief health and lifestyle advice will be sent to encourage healthier behaviour based on clinical studies or topical issues in the media. Links to social networks, such as Facebook posting and the ability to allow chosen family and friends to view their progress will aim to further encourage healthier behaviour.; Other Names: Electronic coaching E-Coaching HAPPY E-Coaching

Outcome Measures

Primary Outcome Measures

1. Change in Pulse Wave Velocity (PWV) [Assessed at Baseline visit, 3 months and 6 months; Month 6 reported]

   Change in aortic stiffness using a Vicorder device measured in m/s

Secondary Outcome Measures

1. Change in Carotid Intima Media Thickness CIMT [Assessed at Baseline visit, 3 months and 6 months; Month 6 reported]

   carotid intima media thickness CIMT as measured by ultrasound

2. Change in Quality of Life [Assessed at Baseline visit, 3 months and 6 months; Data not reported as full analysis not done due to time constraints]

   Lifestyle, quality of life and physical activity questionnaires. Questionnaires SF-36, EQ5D-3L, RPAQ.

3. Pulse Wave Velocity by CMR [Baseline and 6 month. Data not reported as full analysis not possible due to time and resource limitations.]

   Change in aortic stiffness as measured by CMR derived aortic pulse wave velocity measured in m/s

4. Aortic Distensibility by Cardiovascular Magnetic Resonance (CMR) [Baseline and 6 month]

   CMR will be performed on 65 participants in the treatment and 65 in the standard care group. Change in aortic stiffness - aortic distensibility (mmHg-1, CMR)).

5. Left Ventricular Mass by CMR [Baseline and 6 month]

   Change in LV mass index (g/m2, CMR).

6. Left Ventricular Ejection Fraction by CMR [Baseline and 6 month]

   LV end-diastolic and end-systolic volume indices, (ml/m2, CMR), LV EF (%, CMR).

7. Myocardial Fibrosis by CMR [Baseline and 6 month. Baseline and 6 month. Data not reported as full analysis not possible due to time and resource limitations.]

   Extent and change in diffuse myocardial fibrosis (extracellular volume fraction measured as a %, derived from CMR imaging)

8. Diastolic Function by CMR [Baseline and 6 month. Baseline and 6 month. Data not reported as full analysis not possible due to time and resource limitations.]

   Diastolic function (strain and strain rate in % and s-1, respectively derived from CMR imaging data). This is a measure of how stiff the main chamber of the heart is. The software to analyse these data will be available in the future. The raw images from the scan will be used for future analysis once software for this assessment is developed. Our group is working on developing this tool.

9. Change in Framingham Risk Score [Assessed at Baseline visit, 3 months and 6 months; Month 6 reported]

   Assessment of cardiovascular risk based on the Framingham algorithm. Minimum value 0% and maximum value theoretically 100%. Higher score means worse predicted outcome. Assessment of 10-year cardiovascular risk score based on the Framingham population derived algorithm. Minimum value 0% and maximum value theoretically 100%. Higher score means worse predicted outcome.

10. Change in QRisk Score [Assessed at Baseline visit, 3 months and 6 months; Month 6 reported]

    Assessment of cardiovascular risk score based on the QRisk risk score. Minimum value 0% and maximum value theoretically 100%. Higher score means worse predicted outcome. Assessment of cardiovascular risk score based on the UK standardised using the QRISK2 algorithm (www.qrisk.org). Minimum value 0% and maximum value theoretically 100%. Higher score means worse predicted outcome.

11. Change in Total Cholesterol to HDL Ratio [Assessed at Baseline visit, 3 months and 6 months; Month 6 reported]

    Ratio of Total cholesterol to HDL from blood test for lipid profile. Change in the ratio of total cholesterol to HDL cholesterol ratio as assessed though cholesterol blood test. Negative value suggests an improvement.

12. Change in LDL Cholesterol [Assessed at Baseline visit, 3 months and 6 months; Month 6 reported]

    Bloods for lipid profile. Change in the level of LDL cholesterol as assessed though cholesterol blood test. Negative value for change suggests an improvement.

13. Change in Glucose Levels [Assessed at Baseline visit, 3 months and 6 months; Month 6 reported]

    Fasting glucose bloods. This is an assessment for presence of diabetes and control of blood sugar levels on the day of the test. Change in the blood glucose level as measure on the day of the visit as a measure of blood sugar level. Negative value would suggest an improvement.

14. Change in hsCRP [Assessed at Baseline visit, 3 months and 6 months; Month 6 reported]

    baseline and change in hsCRP blood test. hsCRP is measured through a blood test and is a marker of inflammation. Change in the hsCRP level though a blood test. Negative value suggests an improvement.

15. Change in Physical Activity [Assessed at Baseline visit, 3 months and 6 months; Month 6 reported]

    Lifestyle, quality of life and physical activity questionnaires. Questionnaires SF-36, EQ5D-3L, RPAQ

16. Change in Systolic Blood Pressure [Assessed at Baseline visit, 3 months and 6 months; Month 6 reported]

    Change in systolic blood pressure measured during sitting position

17. Change in Diastolic Blood Pressure [Assessed at Baseline visit, 3 months and 6 months; Month 6 reported]

    Change in diastolic blood pressure measure during sitting position.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 74 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects will be enrolled following an informed consent. The subject will be able to understand and comply with protocol requirements, instructions and protocol-stated restrictions

• Subjects will be between 40 and 74 years of age

• Subjects will have unrestricted access to the Internet

• Subjects will be sufficiently fluent in English language.

• Subjects will have an estimated intermediate to high risk for CV events based on the web-based pre-screening tool (www.happylondon.info), which is based on the nonlaboratory Framingham risk score (>10% 10 year cardiovascular risk)

Exclusion Criteria:

• History of stroke or transient ischaemic attack (TIA)

• Cardiac sounding chest pain requiring further investigations

• Current life threatening conditions other than vascular disease (e.g. very severe chronic airways disease, HIV positive, life-threatening arrhythmias) that may prevent a subject from completing the study

• Only for subgroup undergoing cardiac contrast-enhanced magnetic resonance studies: Any contraindication to a contrast-enhanced magnetic resonance study, such as known allergies to gadolinium-based contrast agents, severe claustrophobia, pacemakers, defibrillators, etc

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre for Advanced Cardiovascular Imaging, William Harvey Research Institute, Queen May University of London	London		United Kingdom	E2 9JX

Sponsors and Collaborators

• Queen Mary University of London
• Barts & The London NHS Trust

Investigators

• Principal Investigator: Steffen E Petersen, MD DPhil, Queen Mary University of London

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr Steffen Erhard Petersen, Reader in Advanced Cardiovascular Imaging, Honorary Consultant Cardiologist, Centre Lead for Advanced Cardiovascular Imaging, Queen Mary University of London
• ClinicalTrials.gov Identifier: NCT01911910
• Other Study ID Numbers: ReDa: 007711
• First Posted: Jul 30, 2013
• Last Update Posted: Oct 12, 2020
• Last Verified: Sep 1, 2020

• Keywords provided by Dr Steffen Erhard Petersen, Reader in Advanced Cardiovascular Imaging, Honorary Consultant Cardiologist, Centre Lead for Advanced Cardiovascular Imaging, Queen Mary University of London: primary prevention; Cardiovascular disease; Cardiovascular magnetic resonance (CMR); Electronic coaching (e-coaching)
• Additional relevant MeSH terms: Cardiovascular Diseases; Myocardial Infarction

Study Results

Participant Flow

Arm/Group Title	Standard Care	Electronic Coaching Plus Standard Care
Arm/Group Description	Usual care that would be provided by the NHS Health Check or equivalent.	Tailored coaching for participants randomised to use the HAPPY e-coaching tool. Access to lifestyle and heart health scores and personalised advice to improve suboptimal behaviour. Electronic coaching plus standard care: The HAPPY London web-based tool will provide the participant with an individualised score for their lifestyle and 10 year CV risk score, based mainly on the modified Framingham score, and provide tailored advice and education on the suboptimal factors. Ideal targets will be set and the information will be updated at 3 and 6 months allowing the participant to view their progress. Weekly emails with brief health and lifestyle advice will be sent to encourage healthier behaviour based on clinical studies or topical issues in the media. Links to social networks, such as Facebook posting and the ability to allow chosen family and friends to view their progress will aim to further encourage healthier behaviour.
Period Title: Overall Study
STARTED	197	205
COMPLETED	184	194
NOT COMPLETED	13	11

Baseline Characteristics

Arm/Group Title	Standard Care	Electronic Coaching Plus Standard Care	Total
Arm/Group Description	Usual care that would be provided by the NHS Health Check or equivalent.	Tailored coaching for participants randomised to use the HAPPY e-coaching tool. Access to lifestyle and heart health scores and personalised advice to improve suboptimal behaviour. Electronic coaching plus standard care: The HAPPY London web-based tool will provide the participant with an individualised score for their lifestyle and 10 year CV risk score, based mainly on the modified Framingham score, and provide tailored advice and education on the suboptimal factors. Ideal targets will be set and the information will be updated at 3 and 6 months allowing the participant to view their progress. Weekly emails with brief health and lifestyle advice will be sent to encourage healthier behaviour based on clinical studies or topical issues in the media. Links to social networks, such as Facebook posting and the ability to allow chosen family and friends to view their progress will aim to further encourage healthier behaviour.	Total of all reporting groups
Overall Participants	197	205	402
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.9 (4.8)	65.1 (6.3)	65.5 (5.6)
Sex: Female, Male (Count of Participants)
Female	71 36%	78 38%	149 37.1%
Male	126 64%	127 62%	253 62.9%

Outcome Measures

1. Primary Outcome

Title	Change in Pulse Wave Velocity (PWV)
Description	Change in aortic stiffness using a Vicorder device measured in m/s
Time Frame	Assessed at Baseline visit, 3 months and 6 months; Month 6 reported

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Care	Electronic Coaching Plus Standard Care
Arm/Group Description	Usual care that would be provided by the NHS Health Check or equivalent.	Tailored coaching for participants randomised to use the HAPPY e-coaching tool. Access to lifestyle and heart health scores and personalised advice to improve suboptimal behaviour. Electronic coaching plus standard care: The HAPPY London web-based tool will provide the participant with an individualised score for their lifestyle and 10 year CV risk score, based mainly on the modified Framingham score, and provide tailored advice and education on the suboptimal factors. Ideal targets will be set and the information will be updated at 3 and 6 months allowing the participant to view their progress. Weekly emails with brief health and lifestyle advice will be sent to encourage healthier behaviour based on clinical studies or topical issues in the media. Links to social networks, such as Facebook posting and the ability to allow chosen family and friends to view their progress will aim to further encourage healthier behaviour.
Measure Participants	183	194
Mean (Standard Deviation) [m/s]	-0.25 (1.73)	-0.16 (1.25)

2. Secondary Outcome

Title	Change in Carotid Intima Media Thickness CIMT
Description	carotid intima media thickness CIMT as measured by ultrasound
Time Frame	Assessed at Baseline visit, 3 months and 6 months; Month 6 reported

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Care	Electronic Coaching Plus Standard Care
Arm/Group Description	Usual care that would be provided by the NHS Health Check or equivalent.	Tailored coaching for participants randomised to use the HAPPY e-coaching tool. Access to lifestyle and heart health scores and personalised advice to improve suboptimal behaviour. Electronic coaching plus standard care: The HAPPY London web-based tool will provide the participant with an individualised score for their lifestyle and 10 year CV risk score, based mainly on the modified Framingham score, and provide tailored advice and education on the suboptimal factors. Ideal targets will be set and the information will be updated at 3 and 6 months allowing the participant to view their progress. Weekly emails with brief health and lifestyle advice will be sent to encourage healthier behaviour based on clinical studies or topical issues in the media. Links to social networks, such as Facebook posting and the ability to allow chosen family and friends to view their progress will aim to further encourage healthier behaviour.
Measure Participants	183	194
Mean (Standard Deviation) [mm]	0.01 (0.09)	0.01 (0.08)

3. Secondary Outcome

Title	Change in Quality of Life
Description	Lifestyle, quality of life and physical activity questionnaires. Questionnaires SF-36, EQ5D-3L, RPAQ.
Time Frame	Assessed at Baseline visit, 3 months and 6 months; Data not reported as full analysis not done due to time constraints

Outcome Measure Data

Analysis Population Description

Change in quality of life using the visual analogue scale (VAS) from the EQ-5D questionnaire. Not all participants completed both the baseline and 6-month follow-up, therefore resulting in a lower number analysed compared to other quantitative measures.The highest VAS is score was 1 (best values, highest quality of life).

Arm/Group Title	Standard Care	Electronic Coaching Plus Standard Care
Arm/Group Description	Usual care that would be provided by the NHS Health Check or equivalent.	Tailored coaching for participants randomised to use the HAPPY e-coaching tool. Access to lifestyle and heart health scores and personalised advice to improve suboptimal behaviour. Electronic coaching plus standard care: The HAPPY London web-based tool will provide the participant with an individualised score for their lifestyle and 10 year CV risk score, based mainly on the modified Framingham score, and provide tailored advice and education on the suboptimal factors. Ideal targets will be set and the information will be updated at 3 and 6 months allowing the participant to view their progress. Weekly emails with brief health and lifestyle advice will be sent to encourage healthier behaviour based on clinical studies or topical issues in the media. Links to social networks, such as Facebook posting and the ability to allow chosen family and friends to view their progress will aim to further encourage healthier behaviour.
Measure Participants	162	166
Mean (Standard Deviation) [score on a scale]	0.01 (0.06)	0 (0.16)

4. Secondary Outcome

Title	Pulse Wave Velocity by CMR
Description	Change in aortic stiffness as measured by CMR derived aortic pulse wave velocity measured in m/s
Time Frame	Baseline and 6 month. Data not reported as full analysis not possible due to time and resource limitations.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Aortic Distensibility by Cardiovascular Magnetic Resonance (CMR)
Description	CMR will be performed on 65 participants in the treatment and 65 in the standard care group. Change in aortic stiffness - aortic distensibility (mmHg-1, CMR)).
Time Frame	Baseline and 6 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	Left Ventricular Mass by CMR
Description	Change in LV mass index (g/m2, CMR).
Time Frame	Baseline and 6 month

Outcome Measure Data

Analysis Population Description

CMR data were collected as part of a pilot data in a subgroup of the total number of participants enrolled in the study. Further analysis will take place once funding for further fellow who will be able to perform the detailed software analysis. The data will forms ongoing work.

Arm/Group Title	Standard Care	Electronic Coaching Plus Standard Care
Arm/Group Description	Usual care that would be provided by the NHS Health Check or equivalent.	Tailored coaching for participants randomised to use the HAPPY e-coaching tool. Access to lifestyle and heart health scores and personalised advice to improve suboptimal behaviour. Electronic coaching plus standard care: The HAPPY London web-based tool will provide the participant with an individualised score for their lifestyle and 10 year CV risk score, based mainly on the modified Framingham score, and provide tailored advice and education on the suboptimal factors. Ideal targets will be set and the information will be updated at 3 and 6 months allowing the participant to view their progress. Weekly emails with brief health and lifestyle advice will be sent to encourage healthier behaviour based on clinical studies or topical issues in the media. Links to social networks, such as Facebook posting and the ability to allow chosen family and friends to view their progress will aim to further encourage healthier behaviour.
Measure Participants	42	44
Mean (Standard Deviation) [g/m2]	-1.42 (8.36)	-1.73 (9.4)

7. Secondary Outcome

Title	Left Ventricular Ejection Fraction by CMR
Description	LV end-diastolic and end-systolic volume indices, (ml/m2, CMR), LV EF (%, CMR).
Time Frame	Baseline and 6 month

Outcome Measure Data

Analysis Population Description

Change in the ejection fraction based on the moving images derived from the CMR scan.

Arm/Group Title	Standard Care	Electronic Coaching Plus Standard Care
Arm/Group Description	Usual care that would be provided by the NHS Health Check or equivalent.	Tailored coaching for participants randomised to use the HAPPY e-coaching tool. Access to lifestyle and heart health scores and personalised advice to improve suboptimal behaviour. Electronic coaching plus standard care: The HAPPY London web-based tool will provide the participant with an individualised score for their lifestyle and 10 year CV risk score, based mainly on the modified Framingham score, and provide tailored advice and education on the suboptimal factors. Ideal targets will be set and the information will be updated at 3 and 6 months allowing the participant to view their progress. Weekly emails with brief health and lifestyle advice will be sent to encourage healthier behaviour based on clinical studies or topical issues in the media. Links to social networks, such as Facebook posting and the ability to allow chosen family and friends to view their progress will aim to further encourage healthier behaviour.
Measure Participants	42	44
Mean (Standard Deviation) [% change in ejection fraction]	-0.45 (5.41)	-0.88 (6.29)

8. Secondary Outcome

Title	Myocardial Fibrosis by CMR
Description	Extent and change in diffuse myocardial fibrosis (extracellular volume fraction measured as a %, derived from CMR imaging)
Time Frame	Baseline and 6 month. Baseline and 6 month. Data not reported as full analysis not possible due to time and resource limitations.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

9. Secondary Outcome

Title	Diastolic Function by CMR
Description	Diastolic function (strain and strain rate in % and s-1, respectively derived from CMR imaging data). This is a measure of how stiff the main chamber of the heart is. The software to analyse these data will be available in the future. The raw images from the scan will be used for future analysis once software for this assessment is developed. Our group is working on developing this tool.
Time Frame	Baseline and 6 month. Baseline and 6 month. Data not reported as full analysis not possible due to time and resource limitations.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

10. Secondary Outcome

Title	Change in Framingham Risk Score
Description	Assessment of cardiovascular risk based on the Framingham algorithm. Minimum value 0% and maximum value theoretically 100%. Higher score means worse predicted outcome. Assessment of 10-year cardiovascular risk score based on the Framingham population derived algorithm. Minimum value 0% and maximum value theoretically 100%. Higher score means worse predicted outcome.
Time Frame	Assessed at Baseline visit, 3 months and 6 months; Month 6 reported

Outcome Measure Data

Analysis Population Description

Assessment of 10-year cardiovascular risk score based on the Framingham population derived algorithm. Minimum value 0% and maximum value theoretically 100%. Higher score means worse predicted outcome.

Arm/Group Title	Standard Care	Electronic Coaching Plus Standard Care
Arm/Group Description	Usual care that would be provided by the NHS Health Check or equivalent.	Tailored coaching for participants randomised to use the HAPPY e-coaching tool. Access to lifestyle and heart health scores and personalised advice to improve suboptimal behaviour. Electronic coaching plus standard care: The HAPPY London web-based tool will provide the participant with an individualised score for their lifestyle and 10 year CV risk score, based mainly on the modified Framingham score, and provide tailored advice and education on the suboptimal factors. Ideal targets will be set and the information will be updated at 3 and 6 months allowing the participant to view their progress. Weekly emails with brief health and lifestyle advice will be sent to encourage healthier behaviour based on clinical studies or topical issues in the media. Links to social networks, such as Facebook posting and the ability to allow chosen family and friends to view their progress will aim to further encourage healthier behaviour.
Measure Participants	183	194
Mean (Standard Deviation) [% risk over 10 years]	-1.37 (5.68)	-1.23 (4.47)

11. Secondary Outcome

Title	Change in QRisk Score
Description	Assessment of cardiovascular risk score based on the QRisk risk score. Minimum value 0% and maximum value theoretically 100%. Higher score means worse predicted outcome. Assessment of cardiovascular risk score based on the UK standardised using the QRISK2 algorithm (www.qrisk.org). Minimum value 0% and maximum value theoretically 100%. Higher score means worse predicted outcome.
Time Frame	Assessed at Baseline visit, 3 months and 6 months; Month 6 reported

Outcome Measure Data

Analysis Population Description

Assessment of cardiovascular risk score based on the UK standardised using the QRISK2 algorithm (www.qrisk.org). Minimum value 0% and maximum value theoretically 100%. Higher score means worse predicted outcome.

Arm/Group Title	Standard Care	Electronic Coaching Plus Standard Care
Arm/Group Description	Usual care that would be provided by the NHS Health Check or equivalent.	Tailored coaching for participants randomised to use the HAPPY e-coaching tool. Access to lifestyle and heart health scores and personalised advice to improve suboptimal behaviour. Electronic coaching plus standard care: The HAPPY London web-based tool will provide the participant with an individualised score for their lifestyle and 10 year CV risk score, based mainly on the modified Framingham score, and provide tailored advice and education on the suboptimal factors. Ideal targets will be set and the information will be updated at 3 and 6 months allowing the participant to view their progress. Weekly emails with brief health and lifestyle advice will be sent to encourage healthier behaviour based on clinical studies or topical issues in the media. Links to social networks, such as Facebook posting and the ability to allow chosen family and friends to view their progress will aim to further encourage healthier behaviour.
Measure Participants	183	194
Mean (Standard Deviation) [% risk over 10-years]	-0.05 (2.64)	0.2 (2.52)

12. Secondary Outcome

Title	Change in Total Cholesterol to HDL Ratio
Description	Ratio of Total cholesterol to HDL from blood test for lipid profile. Change in the ratio of total cholesterol to HDL cholesterol ratio as assessed though cholesterol blood test. Negative value suggests an improvement.
Time Frame	Assessed at Baseline visit, 3 months and 6 months; Month 6 reported

Outcome Measure Data

Analysis Population Description

Change in the ratio of total cholesterol to HDL cholesterol ratio as assessed though cholesterol blood test. Negative value suggests an improvement.

Arm/Group Title	Standard Care	Electronic Coaching Plus Standard Care
Arm/Group Description	Usual care that would be provided by the NHS Health Check or equivalent.	Tailored coaching for participants randomised to use the HAPPY e-coaching tool. Access to lifestyle and heart health scores and personalised advice to improve suboptimal behaviour. Electronic coaching plus standard care: The HAPPY London web-based tool will provide the participant with an individualised score for their lifestyle and 10 year CV risk score, based mainly on the modified Framingham score, and provide tailored advice and education on the suboptimal factors. Ideal targets will be set and the information will be updated at 3 and 6 months allowing the participant to view their progress. Weekly emails with brief health and lifestyle advice will be sent to encourage healthier behaviour based on clinical studies or topical issues in the media. Links to social networks, such as Facebook posting and the ability to allow chosen family and friends to view their progress will aim to further encourage healthier behaviour.
Measure Participants	183	194
Mean (Standard Deviation) [ratio]	-0.11 (0.66)	-0.04 (0.55)

13. Secondary Outcome

Title	Change in LDL Cholesterol
Description	Bloods for lipid profile. Change in the level of LDL cholesterol as assessed though cholesterol blood test. Negative value for change suggests an improvement.
Time Frame	Assessed at Baseline visit, 3 months and 6 months; Month 6 reported

Outcome Measure Data

Analysis Population Description

Change in the level of LDL cholesterol as assessed though cholesterol blood test. Negative value for change suggests an improvement.

Arm/Group Title	Standard Care	Electronic Coaching Plus Standard Care
Arm/Group Description	Usual care that would be provided by the NHS Health Check or equivalent.	Tailored coaching for participants randomised to use the HAPPY e-coaching tool. Access to lifestyle and heart health scores and personalised advice to improve suboptimal behaviour. Electronic coaching plus standard care: The HAPPY London web-based tool will provide the participant with an individualised score for their lifestyle and 10 year CV risk score, based mainly on the modified Framingham score, and provide tailored advice and education on the suboptimal factors. Ideal targets will be set and the information will be updated at 3 and 6 months allowing the participant to view their progress. Weekly emails with brief health and lifestyle advice will be sent to encourage healthier behaviour based on clinical studies or topical issues in the media. Links to social networks, such as Facebook posting and the ability to allow chosen family and friends to view their progress will aim to further encourage healthier behaviour.
Measure Participants	183	194
Mean (Standard Deviation) [mmol/L]	-0.2 (0.77)	-0.16 (0.68)

14. Secondary Outcome

Title	Change in Glucose Levels
Description	Fasting glucose bloods. This is an assessment for presence of diabetes and control of blood sugar levels on the day of the test. Change in the blood glucose level as measure on the day of the visit as a measure of blood sugar level. Negative value would suggest an improvement.
Time Frame	Assessed at Baseline visit, 3 months and 6 months; Month 6 reported

Outcome Measure Data

Analysis Population Description

Change in the blood glucose level as measure on the day of the visit as a measure of blood sugar level. Negative value would suggest an improvement.

Arm/Group Title	Standard Care	Electronic Coaching Plus Standard Care
Arm/Group Description	Usual care that would be provided by the NHS Health Check or equivalent.	Tailored coaching for participants randomised to use the HAPPY e-coaching tool. Access to lifestyle and heart health scores and personalised advice to improve suboptimal behaviour. Electronic coaching plus standard care: The HAPPY London web-based tool will provide the participant with an individualised score for their lifestyle and 10 year CV risk score, based mainly on the modified Framingham score, and provide tailored advice and education on the suboptimal factors. Ideal targets will be set and the information will be updated at 3 and 6 months allowing the participant to view their progress. Weekly emails with brief health and lifestyle advice will be sent to encourage healthier behaviour based on clinical studies or topical issues in the media. Links to social networks, such as Facebook posting and the ability to allow chosen family and friends to view their progress will aim to further encourage healthier behaviour.
Measure Participants	183	194
Mean (Standard Deviation) [mmol/L]	-0.27 (0.87)	-0.29 (0.87)

15. Secondary Outcome

Title	Change in hsCRP
Description	baseline and change in hsCRP blood test. hsCRP is measured through a blood test and is a marker of inflammation. Change in the hsCRP level though a blood test. Negative value suggests an improvement.
Time Frame	Assessed at Baseline visit, 3 months and 6 months; Month 6 reported

Outcome Measure Data

Analysis Population Description

Change in the hsCRP level though a blood test. Negative value suggests an improvement.

Arm/Group Title	Standard Care	Electronic Coaching Plus Standard Care
Arm/Group Description	Usual care that would be provided by the NHS Health Check or equivalent.	Tailored coaching for participants randomised to use the HAPPY e-coaching tool. Access to lifestyle and heart health scores and personalised advice to improve suboptimal behaviour. Electronic coaching plus standard care: The HAPPY London web-based tool will provide the participant with an individualised score for their lifestyle and 10 year CV risk score, based mainly on the modified Framingham score, and provide tailored advice and education on the suboptimal factors. Ideal targets will be set and the information will be updated at 3 and 6 months allowing the participant to view their progress. Weekly emails with brief health and lifestyle advice will be sent to encourage healthier behaviour based on clinical studies or topical issues in the media. Links to social networks, such as Facebook posting and the ability to allow chosen family and friends to view their progress will aim to further encourage healthier behaviour.
Measure Participants	183	194
Mean (Standard Deviation) [mg/L]	0 (7.7)	-0.26 (8.19)

16. Secondary Outcome

Title	Change in Physical Activity
Description	Lifestyle, quality of life and physical activity questionnaires. Questionnaires SF-36, EQ5D-3L, RPAQ
Time Frame	Assessed at Baseline visit, 3 months and 6 months; Month 6 reported

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Care	Electronic Coaching Plus Standard Care
Arm/Group Description	Usual care that would be provided by the NHS Health Check or equivalent.	Tailored coaching for participants randomised to use the HAPPY e-coaching tool. Access to lifestyle and heart health scores and personalised advice to improve suboptimal behaviour. Electronic coaching plus standard care: The HAPPY London web-based tool will provide the participant with an individualised score for their lifestyle and 10 year CV risk score, based mainly on the modified Framingham score, and provide tailored advice and education on the suboptimal factors. Ideal targets will be set and the information will be updated at 3 and 6 months allowing the participant to view their progress. Weekly emails with brief health and lifestyle advice will be sent to encourage healthier behaviour based on clinical studies or topical issues in the media. Links to social networks, such as Facebook posting and the ability to allow chosen family and friends to view their progress will aim to further encourage healthier behaviour.
Measure Participants	183	194
Mean (Standard Deviation) [minutes per day over 5 days]	8.45 (118.87)	25.1 (132.85)

17. Secondary Outcome

Title	Change in Systolic Blood Pressure
Description	Change in systolic blood pressure measured during sitting position
Time Frame	Assessed at Baseline visit, 3 months and 6 months; Month 6 reported

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Care	Electronic Coaching Plus Standard Care
Arm/Group Description	Usual care that would be provided by the NHS Health Check or equivalent.	Tailored coaching for participants randomised to use the HAPPY e-coaching tool. Access to lifestyle and heart health scores and personalised advice to improve suboptimal behaviour. Electronic coaching plus standard care: The HAPPY London web-based tool will provide the participant with an individualised score for their lifestyle and 10 year CV risk score, based mainly on the modified Framingham score, and provide tailored advice and education on the suboptimal factors. Ideal targets will be set and the information will be updated at 3 and 6 months allowing the participant to view their progress. Weekly emails with brief health and lifestyle advice will be sent to encourage healthier behaviour based on clinical studies or topical issues in the media. Links to social networks, such as Facebook posting and the ability to allow chosen family and friends to view their progress will aim to further encourage healthier behaviour.
Measure Participants	183	194
Mean (Standard Deviation) [mmHg]	-1.69 (13.91)	-3.18 (12.2)

18. Secondary Outcome

Title	Change in Diastolic Blood Pressure
Description	Change in diastolic blood pressure measure during sitting position.
Time Frame	Assessed at Baseline visit, 3 months and 6 months; Month 6 reported

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Care	Electronic Coaching Plus Standard Care
Arm/Group Description	Usual care that would be provided by the NHS Health Check or equivalent.	Tailored coaching for participants randomised to use the HAPPY e-coaching tool. Access to lifestyle and heart health scores and personalised advice to improve suboptimal behaviour. Electronic coaching plus standard care: The HAPPY London web-based tool will provide the participant with an individualised score for their lifestyle and 10 year CV risk score, based mainly on the modified Framingham score, and provide tailored advice and education on the suboptimal factors. Ideal targets will be set and the information will be updated at 3 and 6 months allowing the participant to view their progress. Weekly emails with brief health and lifestyle advice will be sent to encourage healthier behaviour based on clinical studies or topical issues in the media. Links to social networks, such as Facebook posting and the ability to allow chosen family and friends to view their progress will aim to further encourage healthier behaviour.
Measure Participants	183	194
Mean (Standard Deviation) [mmHg]	-2.08 (6.85)	-2.37 (6.41)

Adverse Events

Time Frame	6 months
Arm/Group Title	Standard Care		Electronic Coaching Plus Standard Care
Arm/Group Description	Usual care that would be provided by the NHS Health Check or equivalent.		Tailored coaching for participants randomised to use the HAPPY e-coaching tool. Access to lifestyle and heart health scores and personalised advice to improve suboptimal behaviour. Electronic coaching plus standard care: The HAPPY London web-based tool will provide the participant with an individualised score for their lifestyle and 10 year CV risk score, based mainly on the modified Framingham score, and provide tailored advice and education on the suboptimal factors. Ideal targets will be set and the information will be updated at 3 and 6 months allowing the participant to view their progress. Weekly emails with brief health and lifestyle advice will be sent to encourage healthier behaviour based on clinical studies or topical issues in the media. Links to social networks, such as Facebook posting and the ability to allow chosen family and friends to view their progress will aim to further encourage healthier behaviour.
All Cause Mortality
	Standard Care		Electronic Coaching Plus Standard Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/197 (0%)		0/205 (0%)
Serious Adverse Events
	Standard Care		Electronic Coaching Plus Standard Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/197 (0%)		0/205 (0%)
Other (Not Including Serious) Adverse Events
	Standard Care		Electronic Coaching Plus Standard Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/197 (0%)		0/205 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.