Cardiac EventNCT05449769
Supporting Cardiac Rehabilitation With eNutriCardio
A study testing eNutriCardio personalised nutrition advice in people with Cardiac Event and Diet Habit, run by University of Reading at 2 sites in United Kingdom.
Trial summary
Following a heart attack or percutaneous coronary intervention (PCI) procedure (to 'open up' narrowed blood vessels in the heart), patients are encouraged to join a cardiac rehabilitation (CR) programme, which provides health and lifestyle advice to assist recovery and reduce risk of future cardiac events. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cardiac Event, Diet Habit, Diet Modification
- What is being tested?
- eNutriCardio personalised nutrition advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 9 Nov 2022to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Pre-screening inclusion criteria (i.e. before patient is approached on the ward):
- Adult patients admitted to RBH following MI or elective PCI procedures
- Eligible to take part in an NHS CR programme run by RBFT or Berkshire Healthcare NHS Trust (identified as living in eligible postcode areas).
Screening inclusion criteria (i.e. screening following the consent process):
- Able to understand verbal and written English without difficulties.
- Able to access eNutriCardio from their usual location (e.g. home): will have access to a suitable device (laptop, computer, tablet or smartphone) AND access to the internet .
- Have an active email address.
Focus group inclusion criteria:
- Request to be contacted about the focus group
- Complete the eNutriCardio questionnaires during week 12
- Take part in an NHS Cardiac Rehabilitation programme
- Can visit the UoR for approximately 1 to 1½ hours
- Able and willing to contribute to a group discussion speaking in English
- Willing to be audio and video recorded
- Other inclusion criteria will already be identified through participation in the pilot study e.g. 18 years and older, able to read and understand English, do not have a dementia or another condition affecting memory
Pre-screening exclusion criteria:
- Diagnosed with dementia or other conditions affecting memory.
- Diagnosed with diabetes (any type).
Screening exclusion criteria:
- Patients unable to give informed consent.
- Pregnant, lactating or planning a pregnancy within the next 5 months.
- Food allergies to dairy, nuts/seeds and/or fish/shellfish.
- Medical conditions/treatments that have a considerable impact on an individual's diet/appetite on a day-to-day basis (e.g. severe gastrointestinal disorders, receiving chemotherapy treatment).
- Usually eat on fewer than 2 occasions per day.
- Receiving dietary advice from a dietitian, nutritionist or medical professional or plan to do so within the next 5 months.
- Following a restrictive diet, such as a vegan diet, meal replacement shake/juice diet (e.g. SlimFast), intermittent fasting diet (e.g. 5:2), very low carbohydrate diet (e.g. keto, Atkins) or any "fad"/"celebrity" diet, or plan to do so within the next 5 months; vegetarians can take part.
- Following a weight-loss programme, such as Weight Watchers, Noom, LighterLife and Slimming World, or plan to do so within the next 5 months; those aiming to lose weight through general healthy eating and "cutting down" without following specialised weight loss advice can take part.
- Taking weight-loss medication (prescribed or over the counter) or plan to do so within the next 5 months.
- Visual and/or physical impairments that prevent an individual from interacting with visual elements on the screen on their device/using their device, such as clicking buttons/mouse or using the touch pad or viewing images.
- Taking part in another research study.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Royal Berkshire Hospital
Reading, Berkshire, RG1 5AN
University of Reading
Reading, Berkshire, RG6 6DZ
About this study
Official title: Piloting a Web-based Personalised Nutrition App (eNutriCardio) With Patients Offered Cardiac Rehabilitation
Following a heart attack or percutaneous coronary intervention (PCI) procedure (to 'open up' narrowed blood vessels in the heart), patients are encouraged to join a cardiac rehabilitation (CR) programme, which provides health and lifestyle advice to assist recovery and reduce risk of future cardiac events. Whilst NICE recommends that CR should "offer people an individual consultation to discuss diet", access to registered dietitians is limited. Instead, CR patients typically receive general healthy eating guidance. Since approximately 50% of patients decline CR, online tools may improve participation. The University of Reading have developed a web-based application (eNutriCardio) that uses a diet questionnaire to assess the quality ('healthiness') of a user's diet. It provides the user with unique, personalised recommendations of foods to increase/reduce to improve diet quality, which aligns with UK public health dietary advice, and incorporates behaviour change techniques.
This pilot study will investigate whether supplementing the usual NHS CR offering with personalised nutrition advice from eNutriCardio (intervention) has a different impact on diet quality and cardiac risk factors (e.g. weight and blood cholesterol) than the CR offering alone (control) after 12 weeks. 82 post-heart attack or PCI patients will provide a dried blood spot sample and record their typical diet using eNutriCardio before being randomly allocated to the control or intervention group. Both groups will be invited to participate in an NHS CR programme, but only intervention participants will receive nutrition advice from eNutriCardio. After 12 weeks, both groups will repeat the diet questionnaire and blood spot sample at home. A follow-up questionnaire will be completed after a further 8 weeks. Participants may also join an optional focus group to discuss their experiences of CR and eNutriCardio. This study is funded by the Health Innovation Partnership, a collaboration between the University of Reading and RBFT.
Read the detailed description
Recruitment will end when 82 participants have been recruited or the recruitment end date (29th February 2024) is reached (whichever comes first). Participants will be screened by the experienced RBFT Cardiology Research Team following their admission to hospital for a myocardial infarction or PCI procedure. Immediately after receiving informed consent and completing the screening form, the Cardiology Research Team will direct eligible participants to eNutriCardio and help them to register. After registration, participants will be randomly allocated by eNutriCardio to either the PN intervention or control group:
- PN intervention group: in addition to the usual NHS CR offering, participants will receive web-based delivery of PN advice based on the participant's dietary intake; PN advice will be unique to each participant.
- Control group: participants will receive the usual NHS CR offering without PN advice from eNutriCardio.
Since people are often more motivated to change their diet following a 'health scare', participants will use eNutriCardio during their hospital stay or be asked to do this within 7 days of discharge to ensure their pre-event/pre-surgery diet is captured at baseline (any new 'healthier' dietary regimes would be misrepresentative of their habitual intake).
This proof-of-principle pilot study will be conducted over 20 weeks alongside the usual NHS CR offering:
- Week 0 (baseline; ideally within 7 days of hospital discharge): participants will use eNutriCardio to complete the eNutri FFQ, to provide self-reported anthropometric measurements (height and weight) and demographic information, and to answer questions on behaviour change, physical activity, computer proficiency, and usability of eNutriCardio (via the system usability scale (SUS)). They will also provide a DBS sample. Those randomised to the PN group will also receive PN advice about their diet via eNutriCardio.
- Approximately 10 days after hospital discharge: as part of the usual CR care, participants will be contacted by a CR team to discuss CR. They may choose to join or decline to take part.
- Approximately week 4-8: as part of usual CR care, participants will start their 6-8 week CR programme (unless they have declined).
- Weeks 2, 4 \& 8: participants in the PN group only will receive interactive coaching emails to set goals and be reminded of their PN advice.
- Week 12 (end of study): participants in both groups will use eNutriCardio to complete the eNutri FFQ, provide self-reported weight, answer questions on physical activity and behaviour change (repeated from week 0), and provide feedback on the CR offering and dietary advice received during the study (e.g. from CR and/or eNutriCardio). They will also provide a second DBS sample.
- Week 20 follow-up: participants in both groups will complete a short online questionnaire about the longer-term effects of the dietary advice received during the study.
- Focus group: after completing the study, 8-10 participants in each group will be invited to participate in an optional focus group at the University of Reading to discuss the dietary advice in more detail.
- Conditions
- Cardiac Event, Diet Habit, Diet Modification
- Being tested
- eNutriCardio personalised nutrition advice
- Keywords
- Food frequency questionnaire, Nutrition, Dietary intake, Diet quality, Cardiac rehabilitation, Personalised nutrition
- Medical subject headings
- Cardiovascular Diseases, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eNutriCardio personalised nutrition adviceBehavioural
eNutriCardio is a web-based app that administers an FFQ and delivers PN advice to the user. The advice is generated from their responses in the FFQ and considers their sex so the reports are unique to each participant. This report (referred to as a 'healthy eating report') will also include an interactive component, allowing the participant to reflect on the advice received and set personal healthy eating goals to motivate behaviour change. The messages presented in the report have been developed by the eNutriCardio Team, including a registered dietitian and registered nutritionist, are in line with UK dietary guidelines (primarily the EatWell Guide), and promote a Mediterranean-style diet (in line with NICE guidance). Therefore, the advice builds on the generalised advice given during the usual NHS CR programme.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Those in the intervention group will receive eNutriCardio PN advice after completing the eNutriCardio FFQ at baseline only. At weeks 2, 4 and 8 of the study, participants will also receive coaching emails which includes reminders of their PN advice and questions asking them to reflect on their goal progress, if any. This will be in addition to their participation in an NHS CR programme (if they choose to join). Receives: Behavioral: eNutriCardio personalised nutrition advice |
| Control group | No intervention | Those in the control group will not receive any PN advice from eNutriCardio and hence, will not receive any coaching emails. They will record their diet using eNutriCardio's FFQ . They will still be eligible to take part in an NHS CR programme. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diet quality score (DQS)
An 11-item eNutriCardio DQS will be automatically calculated by eNutriCardio after completing the FFQ. The eNutri DQS was originally developed to quantify diet quality (i.e., the healthiness of a diet) for Northern European adults and has been revised for a UK population. It is composed of 11 food and nutrient components that are summed to give an overall score, where higher scores reflect the healthiest diets based on adherence to dietary guidelines.
Measured: Baseline
Diet quality score (DQS)
An 11-item eNutriCardio DQS will be automatically calculated by eNutriCardio after completing the FFQ. The eNutri DQS was originally developed to quantify diet quality (i.e., the healthiness of a diet) for Northern European adults and has been revised for a UK population. It is composed of 11 food and nutrient components that are summed to give an overall score, where higher scores reflect the healthiest diets based on adherence to dietary guidelines.
Measured: Week 12
Secondary outcomes (18)
Weight
Self-reported measurement of weight
Measured: Baseline
Weight
Self-reported measurement of weight
Measured: Week 12
Height
Self-reported measurement of height
Measured: Baseline
Body mass index (BMI)
Automatically calculated by eNutriCardio after providing self-reported weight and height
Measured: Baseline
Body mass index (BMI)
Automatically calculated by eNutriCardio after providing self-reported weight and height
Measured: Week 12
eNutriCardio Food Frequency Questionnaire (FFQ) dietary intake data
eNutriCardio is a 158-item FFQ which participants will use to identify how often they typically ate/drank each item during the last 4 weeks (e.g. once a day, less than once a week, not in the last 4 weeks) then choose their typical portion size from a range of 7 photos/buttons. To increase the accuracy of the FFQ, some food/drink items have an extra question, such as the type of milk used on breakfast cereals/hot drinks or whether the food/drink item consumed was a reduced fat/sugar variety. The responses to the FFQ are used to automatically calculate the average intake in grams per day for each item.
Measured: Baseline
eNutriCardio Food Frequency Questionnaire (FFQ) dietary intake data
eNutriCardio is a 158-item FFQ which participants will use to identify how often they typically ate/drank each item during the last 4 weeks (e.g. once a day, less than once a week, not in the last 4 weeks) then choose their typical portion size from a range of 7 photos/buttons. To increase the accuracy of the FFQ, some food/drink items have an extra question, such as the type of milk used on breakfast cereals/hot drinks or whether the food/drink item consumed was a reduced fat/sugar variety. The responses to the FFQ are used to automatically calculate the average intake in grams per day for each item.
Measured: Week 12
Individual DQS component scores, food group intakes (e.g. vegetables, wholegrains) and nutrient intakes (e.g. saturated fat, sodium)
Recorded via eNutriCardio FFQ
Measured: Baseline
Individual DQS component scores, food group intakes (e.g. vegetables, wholegrains) and nutrient intakes (e.g. saturated fat, sodium)
Recorded via eNutriCardio FFQ
Measured: Week 12
Dried blood spot biomarkers
Biochemical markers of dietary intake (such as plasma fatty acids) and cardiovascular risk (such as blood total cholesterol)
Measured: Baseline
Dried blood spot biomarkers
Biochemical markers of dietary intake (such as plasma fatty acids) and cardiovascular risk (such as blood total cholesterol)
Measured: Week 12
Participants motivation and perceived ability to make dietary changes
Measured through a short psychology questionnaire covering ability, opportunity, motivation, and knowledge
Measured: Baseline
Participants motivation and perceived ability to make dietary changes
Measured through a short psychology questionnaire covering ability, opportunity, motivation, and knowledge
Measured: Week 12
Participant feedback on the dietary advice received from eNutriCardio and/or the NHS cardiac rehabilitation programme
Questionnaire covering how effective the dietary advice was at encouraging the participants to make healthy changes to their diet and whether they encountered any barriers
Measured: Week 12
Participant feedback on the cardiac rehabilitation programme (or barriers preventing them from joining)
Questionnaire covering the type of cardiac rehabilitation programme joined (at home or in-person), if any, what their goals are for recovery and whether they would be interested in using an app that can provide advice on certain aspects of cardiac rehabilitation (e.g., diet, smoking, physical activity, weight).
Measured: Week 12
Feedback on the dietary advice received (including eNutriCardio) and experience of the cardiac rehabilitation programme
An optional focus group for participants to discuss the dietary advice they received and their experience of the cardiac rehabilitation programme. One focus group for the intervention group and one focus group for the control group.
Measured: Within 4 months of completing the study
Feedback on the longer-term impact of the dietary advice received
A follow-up questionnaire provided at 20 weeks after joining the study to determine whether there was a longer-term impact of the dietary advice received.
Measured: Week 20
Usability of eNutriCardio measured by the System Usability Scale (SUS)
The SUS is a 10-item questionnaire with 5 response options that range from Strongly Agree to Strongly Disagree and is a reliable tool for measuring usability.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start9 Nov 2022
- Primary completion4 Jun 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac EventStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Berkshire NHS Foundation Trust
- Responsible party
- Principal investigator, Faustina Hwang, University of Reading
- Investigators
- Faustina Hwang, Professor, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449769
- Sponsor's protocol ID
- 301799
- Status last verified
- Aug 2024
- First submitted
- 16 Jun 2022
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share anonymised individual participant data that underlie results in publications in a public repository. Sharing of IPD will be in line with the confidentiality and consent agreements. This may include: * Sociodemographics * Anthropometrics * Dietary intake data * Blood biomarkers
Publications
Zenun Franco R, Fallaize R, Weech M, Hwang F, Lovegrove JA. Effectiveness of Web-Based Personalized Nutrition Advice for Adults Using the eNutri Web App: Evidence From the EatWellUK Randomized Controlled Trial. J Med Internet Res. 2022 Apr 25;24(4):e29088. doi: 10.2196/29088.
PubMed 35468093
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting a Web-based Personalised Nutrition App (eNutriCardio) With Patients Offered Cardiac Rehabilitation
- ClinicalTrials.gov ID
- NCT05449769
- Acronym / sponsor ID
- 301799
- Conditions
- Cardiac Event, Diet Habit, Diet Modification
- Keywords
- Food frequency questionnaire, Nutrition, Dietary intake, Diet quality, Cardiac rehabilitation, Personalised nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- Royal Berkshire NHS Foundation Trust
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- 4 Jun 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 8 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Following a heart attack or percutaneous coronary intervention (PCI) procedure (to 'open up' narrowed blood vessels in the heart), patients are encouraged to join a cardiac rehabilitation (CR) programme, which provides health and lifestyle advice to assist recovery and reduce risk of future cardiac events. Whilst NICE recommends that CR should "offer people an individual consultation to discuss diet", access to registered dietitians is limited. Instead, CR patients typically receive general healthy eating guidance. Since approximately 50% of patients decline CR, online tools may improve participation. The University of Reading have developed a web-based application (eNutriCardio) that uses a diet questionnaire to assess the quality ('healthiness') of a user's diet. It provides the user with unique, personalised recommendations of foods to increase/reduce to improve diet quality, which aligns with UK public health dietary advice, and incorporates behaviour change techniques.
This pilot study will investigate whether supplementing the usual NHS CR offering with personalised nutrition advice from eNutriCardio (intervention) has a different impact on diet quality and cardiac risk factors (e.g. weight and blood cholesterol) than the CR offering alone (control) after 12 weeks. 82 post-heart attack or PCI patients will provide a dried blood spot sample and record their typical diet using eNutriCardio before being randomly allocated to the control or intervention group. Both groups will be invited to participate in an NHS CR programme, but only intervention participants will receive nutrition advice from eNutriCardio. After 12 weeks, both groups will repeat the diet questionnaire and blood spot sample at home. A follow-up questionnaire will be completed after a further 8 weeks. Participants may also join an optional focus group to discuss their experiences of CR and eNutriCardio. This study is funded by the Health Innovation Partnership, a collaboration between the University of Reading and RBFT.
Detailed description
Recruitment will end when 82 participants have been recruited or the recruitment end date (29th February 2024) is reached (whichever comes first). Participants will be screened by the experienced RBFT Cardiology Research Team following their admission to hospital for a myocardial infarction or PCI procedure. Immediately after receiving informed consent and completing the screening form, the Cardiology Research Team will direct eligible participants to eNutriCardio and help them to register. After registration, participants will be randomly allocated by eNutriCardio to either the PN intervention or control group:
- PN intervention group: in addition to the usual NHS CR offering, participants will receive web-based delivery of PN advice based on the participant's dietary intake; PN advice will be unique to each participant.
- Control group: participants will receive the usual NHS CR offering without PN advice from eNutriCardio.
Since people are often more motivated to change their diet following a 'health scare', participants will use eNutriCardio during their hospital stay or be asked to do this within 7 days of discharge to ensure their pre-event/pre-surgery diet is captured at baseline (any new 'healthier' dietary regimes would be misrepresentative of their habitual intake).
This proof-of-principle pilot study will be conducted over 20 weeks alongside the usual NHS CR offering:
- Week 0 (baseline; ideally within 7 days of hospital discharge): participants will use eNutriCardio to complete the eNutri FFQ, to provide self-reported anthropometric measurements (height and weight) and demographic information, and to answer questions on behaviour change, physical activity, computer proficiency, and usability of eNutriCardio (via the system usability scale (SUS)). They will also provide a DBS sample. Those randomised to the PN group will also receive PN advice about their diet via eNutriCardio.
- Approximately 10 days after hospital discharge: as part of the usual CR care, participants will be contacted by a CR team to discuss CR. They may choose to join or decline to take part.
- Approximately week 4-8: as part of usual CR care, participants will start their 6-8 week CR programme (unless they have declined).
- Weeks 2, 4 \& 8: participants in the PN group only will receive interactive coaching emails to set goals and be reminded of their PN advice.
- Week 12 (end of study): participants in both groups will use eNutriCardio to complete the eNutri FFQ, provide self-reported weight, answer questions on physical activity and behaviour change (repeated from week 0), and provide feedback on the CR offering and dietary advice received during the study (e.g. from CR and/or eNutriCardio). They will also provide a second DBS sample.
- Week 20 follow-up: participants in both groups will complete a short online questionnaire about the longer-term effects of the dietary advice received during the study.
- Focus group: after completing the study, 8-10 participants in each group will be invited to participate in an optional focus group at the University of Reading to discuss the dietary advice in more detail.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: eNutriCardio personalised nutrition adviceThose in the intervention group will receive eNutriCardio PN advice after completing the eNutriCardio FFQ at baseline only. At weeks 2, 4 and 8 of the study, participants will also receive coaching emails which includes reminders of their PN advice and questions asking them to reflect on their goal progress, if any. This will be in addition to their participation in an NHS CR programme (if they choose to join). |
| Control group | No intervention | –Those in the control group will not receive any PN advice from eNutriCardio and hence, will not receive any coaching emails. They will record their diet using eNutriCardio's FFQ . They will still be eligible to take part in an NHS CR programme. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eNutriCardio personalised nutrition adviceeNutriCardio is a web-based app that administers an FFQ and delivers PN advice to the user. The advice is generated from their responses in the FFQ and considers their sex so the reports are unique to each participant. This report (referred to as a 'healthy eating report') will also include an interactive component, allowing the participant to reflect on the advice received and set personal healthy eating goals to motivate behaviour change. The messages presented in the report have been developed by the eNutriCardio Team, including a registered dietitian and registered nutritionist, are in line with UK dietary guidelines (primarily the EatWell Guide), and promote a Mediterranean-style diet (in line with NICE guidance). Therefore, the advice builds on the generalised advice given during the usual NHS CR programme. | Behavioural | Intervention group |
Primary outcome
Diet quality score (DQS)
Time frame: Baseline
An 11-item eNutriCardio DQS will be automatically calculated by eNutriCardio after completing the FFQ. The eNutri DQS was originally developed to quantify diet quality (i.e., the healthiness of a diet) for Northern European adults and has been revised for a UK population. It is composed of 11 food and nutrient components that are summed to give an overall score, where higher scores reflect the healthiest diets based on adherence to dietary guidelines.
Diet quality score (DQS)
Time frame: Week 12
An 11-item eNutriCardio DQS will be automatically calculated by eNutriCardio after completing the FFQ. The eNutri DQS was originally developed to quantify diet quality (i.e., the healthiness of a diet) for Northern European adults and has been revised for a UK population. It is composed of 11 food and nutrient components that are summed to give an overall score, where higher scores reflect the healthiest diets based on adherence to dietary guidelines.
18 secondary outcomes
Weight
Time frame: Baseline
Weight
Time frame: Week 12
Height
Time frame: Baseline
Body mass index (BMI)
Time frame: Baseline
Body mass index (BMI)
Time frame: Week 12
eNutriCardio Food Frequency Questionnaire (FFQ) dietary intake data
Time frame: Baseline
eNutriCardio Food Frequency Questionnaire (FFQ) dietary intake data
Time frame: Week 12
Individual DQS component scores, food group intakes (e.g. vegetables, wholegrains) and nutrient intakes (e.g. saturated fat, sodium)
Time frame: Baseline
Individual DQS component scores, food group intakes (e.g. vegetables, wholegrains) and nutrient intakes (e.g. saturated fat, sodium)
Time frame: Week 12
Dried blood spot biomarkers
Time frame: Baseline
Dried blood spot biomarkers
Time frame: Week 12
Participants motivation and perceived ability to make dietary changes
Time frame: Baseline
Participants motivation and perceived ability to make dietary changes
Time frame: Week 12
Participant feedback on the dietary advice received from eNutriCardio and/or the NHS cardiac rehabilitation programme
Time frame: Week 12
Participant feedback on the cardiac rehabilitation programme (or barriers preventing them from joining)
Time frame: Week 12
Feedback on the dietary advice received (including eNutriCardio) and experience of the cardiac rehabilitation programme
Time frame: Within 4 months of completing the study
Feedback on the longer-term impact of the dietary advice received
Time frame: Week 20
Usability of eNutriCardio measured by the System Usability Scale (SUS)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Background: PubMed 35468093Zenun Franco R, Fallaize R, Weech M, Hwang F, Lovegrove JA. Effectiveness of Web-Based Personalized Nutrition Advice for Adults Using the eNutri Web App: Evidence From the EatWellUK Randomized Controlled Trial. J Med Internet Res. 2022 Apr 25;24(4):e29088. doi: 10.2196/29088.
- Individual participant dataSharing planned: Yes. We plan to share anonymised individual participant data that underlie results in publications in a public repository. Sharing of IPD will be in line with the confidentiality and consent agreements. This may include: * Sociodemographics * Anthropometrics * Dietary intake data * Blood biomarkers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faustina Hwang, Professor principal investigator
University of Reading
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eNutriCardio personalised nutrition advice in people with Cardiac Event and Diet Habit, run by University of Reading at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diet quality score (DQS) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05449769, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.