Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-24 @ 10:51 PM
NCT ID:
NCT05449769
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT05449769
Study Brief:
Protocol Section:
NCT05449769