Supporting Cardiac Rehabilitation With eNutriCardio

Sponsor

University of Reading (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05449769

Collaborator

Royal Berkshire NHS Foundation Trust (Other)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

4.1

Patients Per Site Per Month

Study Details

Study Description

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 Royal Berkshire Hospital Trust's (RBFT) 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. 50 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 the RBFT's 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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Event Diet Habit Diet Modification	Behavioral: eNutriCardio personalised nutrition advice	N/A

Detailed Description

50 participants will be recruited and 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 CR offering, participants will receive web-based delivery of PN advice based on the participant's dietary intake and tailored according to their BMI; PN advice will be unique to each participant.
Control group: participants will receive the usual 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 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 CR offering from RBFT:

Week 0 (baseline; 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 the 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-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

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Masking Description:

Due to the nature of the study, the participants and researchers will be unblinded. Although the participants will not be explicitly told which group they are in, they will become aware of their group after completing the eNutriCardio FFQ at baseline. Those randomised to the intervention group will receive their eNutriCardio PN advice and those randomised to the control group will not receive any PN advice from eNutriCardio and therefore know which group they have been allocated to.

Primary Purpose:

Supportive Care

Official Title:

Piloting a Web-based Personalised Nutrition App (eNutriCardio) With Patients Offered Cardiac Rehabilitation

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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 the RBFT CR programme (if they choose to join).	Behavioral: 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 and body mass index 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 RBFT CR programme.
No Intervention: 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 the RBFT CR programme.

Arm

Intervention/Treatment

Experimental: 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 the RBFT CR programme (if they choose to join).

Behavioral: 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 and body mass index 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 RBFT CR programme.

No Intervention: 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 the RBFT CR programme.

Outcome Measures

Primary Outcome Measures

Diet quality score (DQS) [Baseline]
An 11-item eNutriCardio DQS will be automatically calculated by eNutriCardio after completing the FFQ. The eNutri DQS was developed for Northern Europe and quantifies diet quality (i.e. the healthiness of a diet). 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) [Week 12]
An 11-item eNutriCardio DQS will be automatically calculated by eNutriCardio after completing the FFQ. The eNutri DQS was developed for Northern Europe and quantifies diet quality (i.e. the healthiness of a diet). 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

Weight [Baseline]
Self-reported measurement of weight
Weight [Week 12]
Self-reported measurement of weight
Height [Baseline]
Self-reported measurement of height
Body mass index (BMI) [Baseline]
Automatically calculated by eNutriCardio after providing self-reported weight and height
Body mass index (BMI) [Week 12]
Automatically calculated by eNutriCardio after providing self-reported weight and height
eNutriCardio Food Frequency Questionnaire (FFQ) dietary intake data [Baseline]
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.
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.
Individual DQS component scores, food group intakes (e.g. vegetables, wholegrains) and nutrient intakes (e.g. saturated fat, sodium) [Baseline]
Recorded via eNutriCardio FFQ
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
Dried blood spot biomarkers [Baseline]
Biochemical markers of dietary intake (such as blood carotenoids) and cardiovascular risk (such as blood total cholesterol)
Dried blood spot biomarkers [Week 12]
Biochemical markers of dietary intake (such as blood carotenoids) and cardiovascular risk (such as blood total cholesterol)
Participants motivation and perceived ability to make dietary changes [Baseline]
Measured through a short psychology questionnaire covering ability, opportunity, motivation, and knowledge
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 dietary advice received from eNutriCardio and/or the RBH 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
Participant feedback on the cardiac rehabilitation programme (or barriers preventing them from joining) [Week 12]
Questionnaire covering the type of cardiac rehabilitation programme joined (postal 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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 the CR programme run by the RBFT (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 the RBFT 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.