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Cardio Vascular DiseaseNCT07672054

Lifestyle Advice in CVD

An observational study of Cardio Vascular Disease and Dietary Change, run by University of Nottingham at 1 site in United Kingdom.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Individuals living in the UK who are from ethnic minority communities have a higher risk of heart disease and strokes than white individuals. This risk arises from the social determinants of health. These include lifestyle factors such as diet, physical activity and smoking. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Experience of healthcare
How many people
15 participants
Where
1 siteUnited Kingdom
Study dates
6 Jul 2026to 31 Jan 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: UK-based volunteers living in the community who have a personal history of non-white ethnicity and of cardiovascular disease

Who may be able to join

  • Patients over the age of 18 years with a personal history of minority ethnicity (non-white) and a diagnosis of cardiovascular disease

Who cannot join

  • Patients with a personal history of white ethnicity Patients without a history of cardiovascular disease

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

John PJ Frain, MB ChB contact

+447831338172

john.frain@nottingham.ac.uk

United Kingdom1 site
  • Division of Medical Sciences and Graduate Entry Medicine, University of Nottingham Medical School at the Royal Derby Hospital, Derby, United Kingdom. DE22 3DT

    Derby, DE22 3DT

    John PJ Frain, +447831338172, john.frain@nottingham.ac.uk

Other trials in United Kingdom

About this study

Official title: Perspectives and Experience of Patients From Minority Ethic Communities on Advice Provided About Diet and Lifestyle Advice in Management of Their Cardiovascular Disease

Individuals living in the UK who are from ethnic minority communities have a higher risk of heart disease and strokes than white individuals. This risk arises from the social determinants of health. These include lifestyle factors such as diet, physical activity and smoking. Improving these lifestyle factors in individuals is an essential part of reducing the chances of heart attacks and stroke. Patients may have diets and lifestyles arising from their cultural and religious backgrounds but receive advice which is not aligned to their own customs and experiences. Receiving advice which is not relevant to their own types of diet and lifestyle customs may create difficulties for patients in managing their heart and circulation health. Moreover, the dissonance between advice given and patient-specific relevance may lead to poorer adherence to the recommendations made to manage their condition. This can lead to poorer health outcomes for these patients. In addition, they may be advised to adopt diets and behaviours which are not appropriate to their cultures and may be also difficult to put into practice. This is important because lifestyle advice aligned to a patient's existing diet, behaviours and cultural beliefs leads to improved control of these health conditions. Learning to provide dietary and lifestyle advice relevant to individual patients needs is an important skill for the clinicians caring for them.

Read the detailed description

Background The experience of patients from ethnic and differing cultural backgrounds may range from unempathetic to discriminatory. Treatment and management pathways may be contrary to patients' cultural beliefs and values. Lack of awareness of cultural differences among individual clinicians and healthcare organisations contributes to racial disparities in health. The risk of cardiovascular disease is higher in ethnic minorities in developed countries than for white populations. This is reflected in patients of South Asian and African Caribbean heritage living in the UK. Lifestyle factors including diet and physical activity contribute to the social determinants of health which place some communities at a disadvantage relative to others.

Support with self-managing chronic disease can be individual, from family and friends, the wider community as well as from local primary and secondary care services. Social stigma and dietary challenges are significant barriers to effective diabetes management in South Asian patients. The role of family members and religious observance can be important in optimising diabetes management. Adherence to recommended diet is the most significant challenge for diabetes management. While media from healthcare professionals, leaflets and magazines can be valuable, it needs to be culturally attuned. This includes the preferred language of communication for patients. The role of family members in supporting dietary adaptation and adherence is significant.

Cardiovascular risk factors apply across all populations in all regions and include lifestyle factors. Management of lifestyle factors is important in both primary and secondary prevention of cardiovascular disease and requires patient adherence to recommendations. Lifestyle modification programmes can improve patient knowledge, self-care behaviours and glycaemic control when tailored to patient experience, psychosocial characteristics, culture, and worldview. Guidelines should account for patient's daily routines, with cultural and familial expectations of different ages and genders as well as facilitators and barriers for each group. Patients are aware of the facilitators and barriers to behavioural change affecting them though this may not apply to their clinicians and healthcare providers.

Clinicians and organisations providing care to minority ethnic patients with chronic cardiovascular disease need to be aware of the facilitators and barriers to self-management of cardiovascular disease. This includes engendering a sense of personal vulnerability and empowering self-efficacy among individuals to achieve optimal self-care.

Whilst there is existing research on this topic, it is often focussed on self-management of diabetes. Diabetes is itself a risk factor for cardiovascular disease. This study will consider patients' experience of dietary advice and facilitators and barriers to adherence in the context of a diagnosis of cardiovascular disease. Cardiovascular disease is defined as any condition relating to the heart, blood vessels and blood supply to the brain in which the management of risk factors including lifestyle is relevant to preventing the progression of the disease. Studies of risk factors in diverse populations highlight the impact of cross-cultural differences in diet or lifestyle resulting in variation in disease patterns. Diet is very influential on primary prevention of cardiovascular disease. Dietary interventions require tailoring to specific ethnic minority communities. The determinants of food choice include the nutritional environment, economic, cultural and individual factors. As well as the lack of time and motivation affecting white populations, ethnic communities may have issues around cultural commitments including extended family and faith events. Lack of access to culturally relevant information may prevent dietary change. Adjustment of cultural traditions in adaptation to the host country (acculturation) may affect health and dietary habits. In particular for dietary advice, a lack of support post intervention may lead to return to prior habits.

Main research question What are the perspectives and experiences of patients from minority ethnic communities on advice provided on diet and lifestyle advice in management of their cardiovascular disease?

Supplementary question Is the dietary and lifestyle advice provided to ethnic minority patients with cardiovascular disease appropriate to their dietary culture and background?

Data collection methods

Data for the study will be collected using a mixed methods approach and will involve:

  1. One-to-one interviews exploring the lived experience of ethnic community patients and the facilitators and barriers to making recommended changes to diet and lifestyle. This will be using a phenomenological approach exploring patients' dietary and lifestyle changes following diagnosis of cardiovascular disease and how these have been facilitated by healthcare providers.

Summary of known and potential risks and benefits The benefits include an increased level and understanding among healthcare staff, trainees, and educators of the lived experience of minority ethnic individuals with cardiovascular disease. It may also increase confidence and belief among the volunteers in the study of a willingness of healthcare staff and future doctors in wishing to engage, support, and help ethnic minority patients with chronic diseases in which lifestyle and social factors are relevant.

It will assist the student researchers' understanding of communicating sensitively with ethnic minority patients and their possible experiences around dietary and lifestyle advice as well as the facilitators and barriers to change in self-managing their condition.

Interviews may include topics that might be sensitive, embarrassing or upsetting either to the patient volunteers or to the students experiencing similar feelings in their own lives or family and friends. It is possible that other disclosures (e.g. previous unprofessional behaviours by healthcare staff) requiring action could occur during the study.

Description of the population to be studied and special considerations

The study population will be ethnic minority volunteers with a history of established cardiovascular disease. They will be participating to discuss their healthcare experience particularly around dietary and lifestyle advice. Special considerations will be ensuring all participants are fully informed prior to consent regarding the use of data for analysis and storage. Patients from these communities may have previously experienced or witnessed adverse healthcare experiences which may affect their confidence in participating or sharing their thoughts and opinions. Psychological safety should be provided to participants and compliance with University safeguarding procedures should be in place in the event of participant distress.

Being tested
Experience of healthcare
Keywords
Diet, Cardiovascular disease, Ethnicity, Behavioural change, Modification, Healthcare experience, Healthcare access, Medical education
Medical subject headings
Feeding Behavior, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experience of healthcareBehavioural

    Individual participants from ethnic minority groups who have experience of accessing and receiving culturally appropriate dietary advice following a diagnosis and living with cardiovascular disease and their reflections on the educational needs of healthcare staff and medical students in the dietary needs for people with cardiovascular disease from ethnic minority groups.

Study groups in NCT07672054
Study groupRoleWhat they receive
Individuals with cardiovascular diseaseIndividuals from ethnic minority groups with either a personal history of cardiovascular disease or in a caring role for a family member
Receives: Behavioral: Experience of healthcare

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Needs and beliefs of people from ethnic communities

    Discovering the needs and beliefs of patients from ethnic communities on the role of diet and lifestyle factors in the management of their cardiovascular disease

    Measured: 6 months

Secondary outcomes (1)
  1. Barriers and facilitators to culturally appropriate lifestyle advice

    • Is advice on diet and lifestyle to minority ethnic communities culturally appropriate and tailored to their unique needs?
    • What are the facilitators and barriers to providing culturally appropriate dietary and lifestyle advice in cardiovascular disease?
    • What are the facilitators and barriers to complying with dietary and lifestyle advice in cardiovascular advice?

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2026
  2. Study start6 Jul 2026 (estimated)
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion31 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07672054
Sponsor's protocol ID
UNottingham FMHS 123-0425
Status last verified
Jun 2026
First submitted
22 Jun 2026
Last updated
26 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The participants include vulnerable individuals. Even where data is anonymised, it would be appropriate to request IPD only after the study is completed and they have reflected on their experience of participating in the project and had further opportunity to discuss IPD.

Publications

  • Deslippe AL, Soanes A, Bouchaud CC, Beckenstein H, Slim M, Plourde H, Cohen TR. Barriers and facilitators to diet, physical activity and lifestyle behavior intervention adherence: a qualitative systematic review of the literature. Int J Behav Nutr Phys Act. 2023 Feb 14;20(1):14. doi: 10.1186/s12966-023-01424-2.

    PubMed 36782207
  • Satia-Abouta J, Patterson RE, Neuhouser ML, Elder J. Dietary acculturation: applications to nutrition research and dietetics. J Am Diet Assoc. 2002 Aug;102(8):1105-18. doi: 10.1016/s0002-8223(02)90247-6.

    PubMed 12171455
  • Emadian A, England CY, Thompson JL. Dietary intake and factors influencing eating behaviours in overweight and obese South Asian men living in the UK: mixed method study. BMJ Open. 2017 Jul 20;7(7):e016919. doi: 10.1136/bmjopen-2017-016919.

    PubMed 28729327
  • Kris-Etherton PM, Petersen KS, Velarde G, Barnard ND, Miller M, Ros E, O'Keefe JH, Williams K Sr, Horn LV, Na M, Shay C, Douglass P, Katz DL, Freeman AM. Barriers, Opportunities, and Challenges in Addressing Disparities in Diet-Related Cardiovascular Disease in the United States. J Am Heart Assoc. 2020 Apr 7;9(7):e014433. doi: 10.1161/JAHA.119.014433. Epub 2020 Mar 23.

    PubMed 32200727
  • Svetkey LP, Simons-Morton D, Vollmer WM, Appel LJ, Conlin PR, Ryan DH, Ard J, Kennedy BM. Effects of dietary patterns on blood pressure: subgroup analysis of the Dietary Approaches to Stop Hypertension (DASH) randomized clinical trial. Arch Intern Med. 1999 Feb 8;159(3):285-93. doi: 10.1001/archinte.159.3.285.

    PubMed 9989541
  • Chow CK, Jolly S, Rao-Melacini P, Fox KA, Anand SS, Yusuf S. Association of diet, exercise, and smoking modification with risk of early cardiovascular events after acute coronary syndromes. Circulation. 2010 Feb 16;121(6):750-8. doi: 10.1161/CIRCULATIONAHA.109.891523. Epub 2010 Feb 1.

    PubMed 20124123
  • Anand S, Bradshaw C, Prabhakaran D. Prevention and management of CVD in LMICs: why do ethnicity, culture, and context matter? BMC Med. 2020 Jan 24;18(1):7. doi: 10.1186/s12916-019-1480-9.

    PubMed 31973762
  • Gowani A, Ahmed HI, Khalid W, Muqeet A, Abdullah S, Khoja S, Kamal AK. Facilitators and barriers to NCD prevention in Pakistanis-invincibility or inevitability: a qualitative research study. BMC Res Notes. 2016 May 23;9:282. doi: 10.1186/s13104-016-2087-2.

    PubMed 27215828
  • Jose NK, Sruthi MV, Rachel J, Jerome K, Vaz C, Saju CR. Barriers and facilitators of noncommunicable disease (NCD) prevention in Kerala: A qualitative study. J Family Med Prim Care. 2022 Jun;11(6):3109-3114. doi: 10.4103/jfmpc.jfmpc_1471_21. Epub 2022 Jun 30.

    PubMed 36119306
  • Carbone ET, Rosal MC, Torres MI, Goins KV, Bermudez OI. Diabetes self-management: perspectives of Latino patients and their health care providers. Patient Educ Couns. 2007 May;66(2):202-10. doi: 10.1016/j.pec.2006.12.003. Epub 2007 Feb 27.

    PubMed 17329060
  • Yusuf S, Hawken S, Ounpuu S, Dans T, Avezum A, Lanas F, McQueen M, Budaj A, Pais P, Varigos J, Lisheng L; INTERHEART Study Investigators. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet. 2004 Sep 11-17;364(9438):937-52. doi: 10.1016/S0140-6736(04)17018-9.

    PubMed 15364185
  • Tariq O, Rosten C, Huber J. Experiences of living with type 2 diabetes in Pakistan: the role of culture and family in physical activity. Int J Equity Health. 2022 Jul 29;21(1):103. doi: 10.1186/s12939-022-01706-4.

    PubMed 35906689
  • Singh H, Cinnirella M, Bradley C. Support systems for and barriers to diabetes management in South Asians and Whites in the UK: qualitative study of patients' perspectives. BMJ Open. 2012 Nov 14;2(6):e001459. doi: 10.1136/bmjopen-2012-001459. Print 2012.

    PubMed 23151392
  • Sasegbon A, Vasant DH. Understanding racial disparities in the care of patients with irritable bowel syndrome: The need for a unified approach. Neurogastroenterol Motil. 2021 May;33(5):e14152. doi: 10.1111/nmo.14152. Epub 2021 Apr 9.

    PubMed 33835634
  • Vaduganathan M, Mensah GA, Turco JV, Fuster V, Roth GA. The Global Burden of Cardiovascular Diseases and Risk: A Compass for Future Health. J Am Coll Cardiol. 2022 Dec 20;80(25):2361-2371. doi: 10.1016/j.jacc.2022.11.005. Epub 2022 Nov 9. No abstract available.

    PubMed 36368511

Questions about this trial

What is this clinical trial studying?

An observational study of Cardio Vascular Disease and Dietary Change, run by University of Nottingham at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact John PJ Frain, MB ChB (+447831338172, john.frain@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Needs and beliefs of people from ethnic communities (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07672054, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.

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