- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07672054
Lifestyle Advice in CVD
Perspectives and Experience of Patients From Minority Ethic Communities on Advice Provided About Diet and Lifestyle Advice in Management of Their Cardiovascular Disease
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: John PJ Frain, MB ChB
- Phone Number: +447831338172
- Email: john.frain@nottingham.ac.uk
Study Locations
-
-
-
Derby, United Kingdom, DE22 3DT
- Division of Medical Sciences and Graduate Entry Medicine, University of Nottingham Medical School at the Royal Derby Hospital, Derby, United Kingdom. DE22 3DT
-
Contact:
- John PJ Frain
- Phone Number: +447831338172
- Email: john.frain@nottingham.ac.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients over the age of 18 years with a personal history of minority ethnicity (non-white) and a diagnosis of cardiovascular disease
Exclusion Criteria:
- Patients with a personal history of white ethnicity Patients without a history of cardiovascular disease
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Individuals with cardiovascular disease
Individuals from ethnic minority groups with either a personal history of cardiovascular disease or in a caring role for a family member
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Needs and beliefs of people from ethnic communities
Time Frame: 6 months
|
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
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Barriers and facilitators to culturally appropriate lifestyle advice
Time Frame: 6 months
|
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John PJ Frain, Univeristy of Nottingham
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UNottingham FMHS 123-0425
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardio Vascular Disease
-
National Taiwan University HospitalJohnson & JohnsonEnrolling by invitationCardio Vascular Disease | CryoablationTaiwan
-
Nanjing Medical UniversityWest China Hospital; The Affiliated Hospital of Qingdao University; Beijing Anzhen... and other collaboratorsNot yet recruitingCardiopulmonary Bypass | Cardio Vascular DiseaseChina
-
Alliance For Medical Research in AfricaInstitut Pasteur de DakarActive, not recruitingCancer | Mortality | Cardiovascular | Cardio Vascular DiseaseSenegal
-
University Hospital, MontpellierTerminated
-
Gloucestershire Hospitals NHS Foundation TrustNot yet recruitingCardio Vascular DiseaseUnited Kingdom
-
Chinese University of Hong KongRecruitingHyperlipidemia | Cardio Vascular DiseaseHong Kong
-
Mahdi MutaharImperial College London; Temple University; Loughborough UniversityRecruitingVascular Dysfunction | Cardio Vascular Disease | Endothelial Function and Arterial Stiffness | Periodontal Disease (PD) | Oral-Systemic LinkUnited Kingdom
-
The University of Hong KongRecruitingExercise | Fitness Trackers | Cardio Vascular Disease | Physical Activities | Health CoachingHong Kong
-
SINA Health Education and Welfare TrustAga Khan UniversityNot yet recruitingHypertension | Self Care | Cardio Vascular Disease | Educational Intervention | Video Streaming
-
Fondation Hôpital Saint-JosephRecruitingCardio Vascular DiseaseFrance
Clinical Trials on Experience of healthcare
-
University of NottinghamNot yet recruitingLearning Disabilities | Experience | Healthcare AccessUnited Kingdom
-
Assistance Publique - Hôpitaux de ParisNot yet recruiting
-
University of SouthamptonCompleted
-
Meyer Children's Hospital IRCCSUniversity of FlorenceCompletedHospital School ExperienceItaly
-
Florida State UniversityNational Heart, Lung, and Blood Institute (NHLBI)Completed
-
Liverpool School of Tropical MedicineWellcome Trust (Liverpool Clinical PhD Programme)Not yet recruitingMultimorbidity | Chronic Kidney Disease(CKD) | Long-term Health ConditionsMalawi
-
Milton S. Hershey Medical CenterNot yet recruitingBurn Out | Nurses
-
Hospices Civils de LyonUnknown
-
Hospices Civils de LyonRecruitingOptical PhenomenaFrance
-
National Yang Ming UniversityCompletedCardiovascular Diseases | Chronic Kidney Diseases | Type 2 Diabetes MellitusTaiwan