Supporting Cardiac Rehabilitation With eNutriCardio

Diet Habit Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05449769
• Other study ID #: 301799
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 9, 2022
• Est. completion date: August 2024

Study information

• Verified date: March 2024
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 61
• Est. completion date: August 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Event
• Cardiovascular Diseases
• Diet Habit
• Diet Modification

Intervention

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 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.

Locations

Country	Name	City	State
United Kingdom	Royal Berkshire Hospital	Reading	Berkshire
United Kingdom	University of Reading	Reading	Berkshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Reading	Royal Berkshire NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	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.	Week 12
Secondary	Weight	Self-reported measurement of weight	Baseline
Secondary	Weight	Self-reported measurement of weight	Week 12
Secondary	Height	Self-reported measurement of height	Baseline
Secondary	Body mass index (BMI)	Automatically calculated by eNutriCardio after providing self-reported weight and height	Baseline
Secondary	Body mass index (BMI)	Automatically calculated by eNutriCardio after providing self-reported weight and height	Week 12
Secondary	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.	Baseline
Secondary	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.	Week 12
Secondary	Individual DQS component scores, food group intakes (e.g. vegetables, wholegrains) and nutrient intakes (e.g. saturated fat, sodium)	Recorded via eNutriCardio FFQ	Baseline
Secondary	Individual DQS component scores, food group intakes (e.g. vegetables, wholegrains) and nutrient intakes (e.g. saturated fat, sodium)	Recorded via eNutriCardio FFQ	Week 12
Secondary	Dried blood spot biomarkers	Biochemical markers of dietary intake (such as plasma fatty acids) and cardiovascular risk (such as blood total cholesterol)	Baseline
Secondary	Dried blood spot biomarkers	Biochemical markers of dietary intake (such as plasma fatty acids) and cardiovascular risk (such as blood total cholesterol)	Week 12
Secondary	Participants motivation and perceived ability to make dietary changes	Measured through a short psychology questionnaire covering ability, opportunity, motivation, and knowledge	Baseline
Secondary	Participants motivation and perceived ability to make dietary changes	Measured through a short psychology questionnaire covering ability, opportunity, motivation, and knowledge	Week 12
Secondary	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	Week 12
Secondary	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).	Week 12
Secondary	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.	Within 4 months of completing the study
Secondary	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.	Week 20
Secondary	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.	Baseline