Supporting Cardiac Rehabilitation With eNutriCardio
- Conditions
- Diet HabitDiet ModificationCardiac Event
- Interventions
- Behavioral: eNutriCardio personalised nutrition advice
- Registration Number
- NCT05449769
- Lead Sponsor
- University of Reading
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group eNutriCardio personalised nutrition advice 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).
- Primary Outcome Measures
Name Time Method Diet quality score (DQS) 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.
- Secondary Outcome Measures
Name Time Method Height Baseline Self-reported measurement of height
Body mass index (BMI) Week 12 Automatically calculated by eNutriCardio after providing self-reported weight and height
Individual DQS component scores, food group intakes (e.g. vegetables, wholegrains) and nutrient intakes (e.g. saturated fat, sodium) Week 12 Recorded via eNutriCardio FFQ
Participants motivation and perceived ability to make dietary changes Week 12 Measured through a short psychology questionnaire covering ability, opportunity, motivation, and knowledge
Participant feedback on the cardiac rehabilitation programme (or barriers preventing them from joining) Week 12 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).
Feedback on the dietary advice received (including eNutriCardio) and experience of the cardiac rehabilitation programme Within 4 months of completing the study 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.
Feedback on the longer-term impact of the dietary advice received Week 20 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.
Weight Week 12 Self-reported measurement of weight
Dried blood spot biomarkers Week 12 Biochemical markers of dietary intake (such as plasma fatty acids) and cardiovascular risk (such as blood total cholesterol)
Participant feedback on the dietary advice received from eNutriCardio and/or the NHS cardiac rehabilitation programme Week 12 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
Usability of eNutriCardio measured by the System Usability Scale (SUS) Baseline 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.
eNutriCardio Food Frequency Questionnaire (FFQ) dietary intake data Week 12 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.
Trial Locations
- Locations (2)
Royal Berkshire Hospital
🇬🇧Reading, Berkshire, United Kingdom
University of Reading
🇬🇧Reading, Berkshire, United Kingdom