Supporting Cardiac Rehabilitation With eNutriCardio

NCT05449769 | Completed

• 1 other identifier: 301799
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 2

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.

Conditions

Cardiac Event; Diet Habit; Diet Modification

Keywords

Food frequency questionnaire; Nutrition; Dietary intake; Diet quality; Cardiac rehabilitation; Personalised nutrition

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (18)

• Weight

  Baseline

• Weight

  Week 12

• Height

  Baseline

• Body mass index (BMI)

  Baseline

• Body mass index (BMI)

  Week 12

Study Arms (2)

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).

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.

Interventions

eNutriCardio personalised nutrition advice 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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Reading: lead
• Royal Berkshire NHS Foundation Trust: collaborator

Study Sites (2)

Royal Berkshire Hospital

Reading, Berkshire, RG1 5AN, United Kingdom

Location

University of Reading

Reading, Berkshire, RG6 6DZ, United Kingdom

Location

Related 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.

  PMID: 35468093 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Officials

• Faustina Hwang, Professor

  University of Reading

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: July 8, 2022
• Study Start: November 9, 2022
• Primary Completion: June 4, 2024
• Study Completion: July 30, 2024
• Last Updated: August 2, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: No later than the time of first publication and available indefinitely thereafter.
• Access Criteria: We plan for open access.

Locations

GB (2)