Supporting Cardiac Rehabilitation With eNutriCardio

NCT ID: NCT05449769

Last Updated: 2024-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-09
• Study Completion Date: 2024-07-30

Brief 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. 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.

Conditions

Cardiac Event; Diet Habit; Diet Modification

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention group

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).

Group Type: EXPERIMENTAL

eNutriCardio personalised nutrition advice

Intervention Type: BEHAVIORAL

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.

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

eNutriCardio personalised nutrition advice

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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).

• 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.

• 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

Exclusion Criteria

• Diagnosed with dementia or other conditions affecting memory.
• Diagnosed with diabetes (any type).

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal Berkshire NHS Foundation Trust

OTHER_GOV

Sponsor Role: collaborator

University of Reading

OTHER

Sponsor Role: lead

Responsible Party

Faustina Hwang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Faustina Hwang, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Reading

Locations

Royal Berkshire Hospital

Reading, Berkshire, United Kingdom

University of Reading

Reading, Berkshire, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 35468093 (View on PubMed)

Other Identifiers

301799

Identifier Type: -

Identifier Source: org_study_id