Full Terms & Conditions of access and use can be found at https://www.tandfonline.com/action/journalInformation?journalCode=zgha20 Global Health Action ISSN: (Print) (Online) Journal homepage: www.tandfonline.com/journals/zgha20 The contextual awareness, response and evaluation (CARE) diabetes project: study design for a quantitative survey of diabetes prevalence and non-communicable disease risk in Ga Mashie, Accra, Ghana Swaib Abubaker Lule, Sandra Boatemaa Kushitor, Carlos S. Grijalva- Eternod, Kafui Adjaye-Gbewonyo, Olutobi Adekunle Sanuade, Mawuli Komla Kushitor, Lydia Okoibhole, Raphael Awuah, Leonard Baatiema, Irene Akwo Kretchy, Daniel Arhinful, Ama de-Graft Aikins, Kwadwo Koram, Edward Fottrell & the CARE Diabetes Team To cite this article: Swaib Abubaker Lule, Sandra Boatemaa Kushitor, Carlos S. Grijalva- Eternod, Kafui Adjaye-Gbewonyo, Olutobi Adekunle Sanuade, Mawuli Komla Kushitor, Lydia Okoibhole, Raphael Awuah, Leonard Baatiema, Irene Akwo Kretchy, Daniel Arhinful, Ama de- Graft Aikins, Kwadwo Koram, Edward Fottrell & the CARE Diabetes Team (2024) The contextual awareness, response and evaluation (CARE) diabetes project: study design for a quantitative survey of diabetes prevalence and non-communicable disease risk in Ga Mashie, Accra, Ghana, Global Health Action, 17:1, 2297513, DOI: 10.1080/16549716.2023.2297513 To link to this article: https://doi.org/10.1080/16549716.2023.2297513 © 2024 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group. Published online: 07 Feb 2024. Submit your article to this journal Article views: 720 View related articles View Crossmark data https://www.tandfonline.com/action/journalInformation?journalCode=zgha20 https://www.tandfonline.com/journals/zgha20?src=pdf https://www.tandfonline.com/action/showCitFormats?doi=10.1080/16549716.2023.2297513 https://doi.org/10.1080/16549716.2023.2297513 https://www.tandfonline.com/action/authorSubmission?journalCode=zgha20&show=instructions&src=pdf https://www.tandfonline.com/action/authorSubmission?journalCode=zgha20&show=instructions&src=pdf https://www.tandfonline.com/doi/mlt/10.1080/16549716.2023.2297513?src=pdf https://www.tandfonline.com/doi/mlt/10.1080/16549716.2023.2297513?src=pdf http://crossmark.crossref.org/dialog/?doi=10.1080/16549716.2023.2297513&domain=pdf&date_stamp=07 Feb 2024 http://crossmark.crossref.org/dialog/?doi=10.1080/16549716.2023.2297513&domain=pdf&date_stamp=07 Feb 2024 STUDY DESIGN ARTICLE The contextual awareness, response and evaluation (CARE) diabetes project: study design for a quantitative survey of diabetes prevalence and non-communicable disease risk in Ga Mashie, Accra, Ghana Swaib Abubaker Lulea, Sandra Boatemaa Kushitorb,c, Carlos S. Grijalva-Eternoda,d, Kafui Adjaye-Gbewonyoe, Olutobi Adekunle Sanuadef, Mawuli Komla Kushitorg, Lydia Okoibholea, Raphael Awuahh, Leonard Baatiemai,j, Irene Akwo Kretchyk, Daniel Arhinfulh, Ama de-Graft Aikinsl, Kwadwo Koramh, Edward Fottrell a and the CARE Diabetes Team aInstitute for Global Health, University College London, London, UK; bDepartment of Community Health, Ensign Global College, Kpong, Ghana; cDepartment of Food Science and Centre for Sustainability Studies, Stellenbosch University, Stellenbosch, South Africa; dDepartment of Population Health, London School of Hygiene and Tropical Medicine, London, UK; eInstitute for Lifecourse Development, University of Greenwich, London, UK; fDepartment of Population Health Sciences, Division of Health System Innovation and Research, Spencer Fox Eccles School of Medicine at the University of Utah, Salt Lake City, UT, USA; gDepartment of Health Policy, Fred Binka School of Public Health, University of Health and Allied Sciences, Ho, Ghana; hNoguchi Memorial Institute for Medical Research, University of Ghana, Accra, Ghana; iDepartment of Health Policy, Planning and Management, School of Public Health, University of Ghana, Accra, Ghana; jCenter for Tropical Medicine and Global Health Research, Nuffield Department of Medicine, University of Oxford, Oxford, UK; kDepartment of Pharmacy Practice and Clinical Pharmacy, School of Pharmacy, University of Ghana, Accra, Ghana; lInstitute of Advanced Studies, University College London, London, UK ABSTRACT Diabetes is estimated to affect between 3.3% and 8.3% of adults in Ghana, and prevalence is expected to rise. The lack of cost-effective diabetes prevention programmes designed speci- fically for the Ghanaian population warrants urgent attention. The Contextual Awareness, Response and Evaluation (CARE): Diabetes Project in Ghana is a mixed methods study that aims to understand diabetes in the Ga Mashie area of Accra, identify opportunities for community-based intervention and inform future diabetes prevention and control strategies. This paper presents the study design for the quantitative survey within the CARE project. This survey will take place in the densely populated Ga Mashie area of Accra, Ghana. A household survey will be conducted using simple random sampling to select households from 80 enumeration areas identified in the 2021 Ghana Population and Housing Census. Trained enumerators will interview and collect data from permanent residents aged ≥ 25 years. Pregnant women and those who have given birth in the last six months will be excluded. Data analysis will use a combination of descriptive and inferential statistics, and all analyses will account for the cluster sampling design. Analyses will describe the prevalence of diabetes, other morbidities, and associated risk factors and identify the relationship between diabetes and physical, social, and behavioural parameters. This survey will generate evidence on drivers and consequences of diabetes and facilitate efforts to prevent and control diabetes and other NCDs in urban Ghana, with relevance for other low-income communities. ARTICLE HISTORY Received 1 September 2023 Accepted 16 December 2023 RESPONSIBLE EDITOR Stig Wall KEYWORDS Type 2 diabetes mellitus; Accra; epidemiology; non- communicable diseases; urban poor communities Introduction Diabetes is a chronic, non-communicable disease (NCD) characterised by an increase in blood glucose concentra- tions [1]. Of the three main types of diabetes – type 1, type 2, and gestational diabetes – type 2 accounts for over 90% of all people living with diabetes globally [2]. Those with diabetes are at an increased risk of micro- and macro- vascular complications including, but not limited to, neuropathy, vision loss, and stroke, with implications for quality of life, longevity and individual, household and community economics [3–5]. Globally in 2021, one in ten (537 million) adults between 20–79 years of age were living with diabetes [6], rising from 4·7% in 1980 and 8·5% in 2014 [7,8]. Prevalence is higher in urban than rural areas and in high-income compared to low-income settings [2,9,10]. Global prevalence is expected to rise to 10.2% (578 million) by 2030 and to 12.2% (783 million) by 2045 [2,10] with over two-thirds of this rise occurring in low- and middle-income coun- tries (LMICs) [10–12]. Since there may be no warn- ing signs and early symptoms can be non-specific and CONTACT Edward Fottrell e.fottrell@ucl.ac.uk Institute for Global Health, University College London, 30 Guilford Street, London WC1N 1EH, UK *Joint first authors. #Moses Aikins, Samuel Amon, Publa Antwi, Ann Blandford, Hassan Haghparast-Bidgoli, Sarah Hawkes, Hannah Jennings, Ernestina Korleki Dankyi, Sedzro Kojo Mensah, Daniel Strachan, Megan Vaughan, Haim Yacobi. GLOBAL HEALTH ACTION 2024, VOL. 17, 2297513 https://doi.org/10.1080/16549716.2023.2297513 © 2024 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The terms on which this article has been published allow the posting of the Accepted Manuscript in a repository by the author(s) or with their consent. http://orcid.org/0000-0003-0518-7161 http://www.tandfonline.com https://crossmark.crossref.org/dialog/?doi=10.1080/16549716.2023.2297513&domain=pdf&date_stamp=2024-02-02 difficult to recognise, one in two people living with diabetes are unaware of their condition [2]. In Africa, diabetes prevalence has risen signifi- cantly over recent decades and an estimated 55 million people are forecasted to have diabetes in Africa by 2045 [6,8,12]. It is estimated that approximately one in 22 adults (24 million) on the continent were living with diabetes in 2021, resulting in nearly 416,000 deaths [6,10]. Relative to other regions, the African continent has the largest proportion of people with undiagnosed dia- betes, with 54% (13 million) of adults living with diabetes but unaware of it [6,10]. Estimates of dia- betes prevalence in Ghana range from 4.0% to 8.3% [9,13] and, it is expected that prevalence will rise [14]. The increase in diabetes prevalence is driven in part by urbanisation and changes in diet and life- styles [2,9,15]. Diabetes is associated with physical inactivity, increasing age, overweight or obesity, poor dietary intake, tobacco use, alcohol consump- tion, and socioeconomic factors such as education, employment status, wealth, and social class [7,9]. The rise in diabetes prevalence is expected to also increase the number of individuals living with other chronic and acute diseases, with profound effects on their quality of life and functioning, leading to poor mental and physical health, prema- ture mortality, increased demand for health ser- vices, and high economic costs [7,15,16]. Despite this high and increasing diabetes prevalence, little research focuses on understanding the burden and context of diabetes among adults in most LMICs, including Ghana [17]. Although evidence is consis- tent on the growing health and economic burden of diabetes and other NCDs in sub-Saharan Africa (SSA), efforts to prevent and control NCDs remain insufficient [18,19]. In addition to the scarcity of dedicated resources, implementing prevention and control strategies in Africa is impeded by a lack of knowledge of previous evidence-based interven- tions [19]. Behaviours related to diet, physical activity, reg- ular screening and treatment are known to prevent or delay the consequences of diabetes [4]. However, socio-cultural (e.g. social norms, traditions, and customs) and economic factors, as well as aware- ness of ones’ diabetic status, are important deter- minants of these behaviours [20]. Previous studies from Ghana showed that perceptions of risk, unwillingness or inability to change behaviour, lack of support, social stigma, poverty, long dis- tance to healthcare facilities, and poor access to healthy foods are some of the barriers to diabetes prevention and management [21–23]. The lack of cost-effective diabetes prevention programmes explicitly designed for Ghanaian populations warrants urgent attention [24]. For interventions to succeed, understanding the local context and knowledge of previous effective interventions is vital [17]. The ‘Contextual Awareness, Response and Evaluation (CARE): Diabetes in Ghana’ project is a mixed methods study in Ga Mashie, Accra, using an epidemiological survey alongside qualita- tive methods to generate a contextual understand- ing of diabetes in an urban poor population. The CARE project builds on earlier work on diabetes in Accra, Ghana, by the Regional Institute for Population Studies (RIPS) Urban Health and Poverty Project [24–27]. In this paper, we describe the CARE survey protocol for the quantitative component of the CARE project. The protocol of the qualitative component is described elsewhere. The CARE project aim The CARE project aims to generate data to under- stand the burden, narratives, socio-ecological drivers, consequences, and responses to diabetes in Ga Mashie and identify opportunities for community- based interventions for diabetes prevention and con- trol. The current paper describes the survey methods for the quantitative component of the CARE Diabetes project; the qualitative study design and methods are described in detail elsewhere. The CARE survey objectives The primary objective of the CARE Survey is to estimate the prevalence and distribution of diabetes and NCD risk factors among adults in Ga Mashie. The secondary objectives are to: (1) Estimate the prevalence of multimorbidity in Ga Mashie at the individual and household level, as defined by the co-occurrence at least two of diabetes, hypertension or obesity in one or different household members. (2) Estimate the prevalence of other non- communicable diseases and risk factors and their association with diabetes and multimorbidity. (3) Quantify care-seeking behaviours for diabetes care. (4) Estimate associations between contextual fac- tors and risk of diabetes. Methods Study design, setting and population The CARE Survey is a cross-sectional epidemiological study whereby trained local enumerators will collect data from households and individuals in Ga Mashie, 2 S. A. LULE ET AL. Accra, and will use Global Positioning System (GPS) to map the commercial and built environment, including the locations of all food and drink outlets, health facil- ities and physical, religious, and social spaces. Ga Mashie comprises James Town and Ussher Town across an area of 100 hectares east of the Korle Lagoon on the southwest coast of Accra. It is a densely populated urban setting with a population of around 120,000 and is characterised by low socio- economic status, low literacy rates, poor sanitary con- ditions, and predominantly old housing structures [28,29]. Housing consists mostly of double-storey compound houses constructed of sand-concrete blocks and bricks and roofed with aluminium sheet- ing, slate, or asbestos sheets and arranged into clus- ters connected via alleyways paved with blocks. On average, over five families reside within a single prop- erty; typically, each compound house has 10 to 15 rooms [28,29]. Figure 1 shows the aerial view of Ga Mashie, illustrating the densely populated, urban context. The area has several formal and informal health- care providers, including Ussher Town Polyclinic, a government facility [30]. The community of Ga Mashie consists mainly of the indigenous Ga people and migrant populations from other regions [28]. Fishing remains a major source of livelihood, though small-scale trading and other commercial activities now dominate the community [28,31]. London and Salaga markets serve the area, which is important for trade in a wider variety of local food and non-food items. Street trading is commonly engaged in by most households, with food such as Kenkey (a staple dish) often sold in front of many homes [28]. Study participant inclusion and exclusion criteria All individuals aged ≥25 years who are permanent resi- dents of the selected households will be eligible to parti- cipate in the survey. For the purposes of our study, we define a permanent resident as someone who has lived in a selected household for the past 12 months. A household is defined as a single person living alone or a group of people who may or may not be related but live at the same address and share cooking facilities, a living room, a sitting room, or a dining area [32]. Pregnancy is known to affect blood glucose and blood pressure (BP) and so pregnant women or those who have given birth within the last six months will be excluded from our survey. Additionally, anyone deemed unable to provide informed consent or complete the survey, such as individuals with impaired mental capa- city or who are deaf and unaided, will also be excluded. Sample size and sampling methods To calculate the survey sample, we used an assumed diabetes prevalence of 5.0%, a precision of 2.0% and a design effect of 2.5. The assumed prevalence of 5.0% was based on the lowest (thus most conservative) prevalence identified from a review of previous dia- betes studies in Ghana [9]. This calculation resulted in a required sample size of 1,242 individuals. To determine the number of households needed for the survey, we estimated that each household would have an average of two eligible adults, with a 10% refusal rate, resulting in a sample of 684 households. However, based on previous field experiences of some of the authors, we further assumed that 40% of households would be empty or non-traceable, lead- ing to an increased sample size of 958 households. We will conduct the survey in the 80 enumeration areas (EAs) of Ga Mashie to ensure a broad geogra- phical representation by including households from all EAs (Figure 2). The Ghana Statistical Service (GSS), which conducted the 2021 Ghana Population and Housing Census (including enumeration of Ga Mashie), will apply simple random sampling to pro- vide a sample of 12 households within each EA for inclusion in this study. As a result, the final sample size will increase to 960 households. Preparations A community engagement activity will be conducted before starting the survey. This will be a participatory Figure 1. An aerial view of Ga Mashie. GLOBAL HEALTH ACTION 3 event engaging sections of the community, including chiefs, female traditional leaders (often referred to as Queen Mothers), market leaders, fisherfolk, butchers, boxers, and health care providers, among others. The activity will be designed to introduce and explain the project, answer questions, and obtain the views of the potential project participants. We will partner with the local health authorities to create a health information leaflet about diabetes. The leaflet will describe diabetes, its risk factors, signs, and symptoms, as well as the care and management of the disease. During the survey, we will provide each household with a copy of the leaflet to learn more about identifying, preventing, and treating dia- betes and related risk factors. The leaflet will also provide information about where to access related services and treatment. Survey team Forty enumerators will be recruited to conduct the survey. They will undergo a three-day training pro- gramme on survey tools and data collection proce- dures, including obtaining informed consent, conducting participant interviews, maintaining con- fidentiality, measuring, and recording anthropo- metric, blood glucose, and BP data, and using the Open Data Kit (ODK) questionnaires on a mobile device. Standard Operating Procedures (SOPs) with detailed procedures to be followed by the survey staff will be developed. A standardisation exercise will be conducted dur- ing the training to ensure reliable anthropometric measurements. The exercise will consist of two ses- sions, each measuring five adult volunteers in five stations. Each station will have a height board, weight scale, measuring tape, and a mobile device for enter- ing data. During the first session, a group of anthro- pometric trainees will measure the adult volunteers’ height, weight, and waist circumference twice, at two independent time points. They will move in a clockwise direction to cover all stations. In the second session, the trainees will measure a new set of five volunteers, following the same pattern as in the first session. This approach will help to identify intra- and inter-observer variability and address any apparent inconsistencies or errors in measurement techniques. Consent We will invite all eligible members of the selected households to participate in the survey, and data collection will only start after obtaining informed consent. Enumerators will guide participants through the consenting process by providing information on what the survey is about, the purpose of the survey, what to expect, voluntary participation and disconti- nuation of participation, benefits and risks for parti- cipation, and who is conducting the survey. In this process, enumerators will provide sufficient time to ask questions and provide answers before requesting consent. It is possible that some study participants will be illiterate. In preparation for such instances, enumerators will be trained to verbally explain the study to the participant in the presence of a witness. If the participant understands more than one lan- guage, whenever possible, the consent process will be conducted in the preferred language of the parti- cipant. In the rare event that the enumerators do not Figure 2. Enumeration area map of Ga Mashie. 4 S. A. LULE ET AL. speak any language spoken by the participant, the participant will be excluded and the reason for exclu- sion recorded. If individuals choose to participate, they will sign the consent form in duplicate and keep one of the copies. A witness will sign in the instance of the participant being illiterate. The remaining copy will be kept securely at the University of Ghana. Participants will receive fresh fruit juice and a cracker, soaps and money as com- pensation for participating in the survey. Procedures We aim to conduct field activities over six weeks. Individual level data will be gathered from each consenting eligible individual within each household. In addition to providing their own individual-level data, household heads (the main earner or one that is responsible for purchases) as defined by house- hold members will provide data on household level data. To estimate the prevalence of common NCD risk factors and their association with diabetes and quan- tify care-seeking behaviours for diabetes, individual and household data will be collected from the respon- dents. For the purposes of our study, we use the term ‘risk factors’ to refer to personal or contextual factors associated with an increase in the outcomes of inter- est. Individual-level data will be collected from all eligible participants. We will obtain detailed informa- tion on diabetes, other NCDs and related risk factors, awareness, and risk perception. Information on sociodemographic characteristics, psychosocial well- being, physical activity, dietary intake, alcohol use, tobacco use, physical activity and exercise, and health service utilisation among study participants will also be obtained. Table 1 summarises the measures taken, operational definitions, rationale and tools to be used. Blood glucose, BP, and anthropometry (weight, height, and waist circumference) measurements will be used to estimate diabetes, hypertension, and obe- sity, respectively. We will estimate random blood glu- cose concentration by using a point-of-care glucometer (One Touch select plus, LifeScan Europe GmbH 6300 Zug, Switzerland) on capillary whole blood obtained from the middle figure following a finger prick. Whilst random blood glucose is not a diagnostic test for diabetes, it is useful for identifying risk of diabetes in population-based surveys where alternative measures such as fasting blood glucose and two-hour glucose tolerance tests are difficult to obtain [33]. As such, we define diabetes in our survey as random glucose concentration ≥11.1 mmol/L [3,34]. Three BP measurements will be taken on the left arm (except where not possible) raised at the heart level with a one-minute interval between measure- ments after an initial rest, with the participant seated quietly for at least five minutes [35]. An appropriate size cuff on a digital BP monitor (OMRON – M7 intelli IT HEM-7361T-EBK, Vietnam) will be used. The aver- age of the second and third BP measurements will be used to estimate systolic and diastolic BP. Evidence from earlier studies shows that the second and third BP measurements are, on average, more consistent and lower than the first BP measurement [36, 37]. Hypertension will be defined as systolic BP ≥140 mmHg and/or diastolic BP ≥90 mmHg or a self- reported diagnosis of hypertension by a medical pro- fessional or self-reported use of antihypertensive medication. When measuring weight, participants will be asked to stand unsupported on the centre of the scale, with the weight distributed evenly on both feet, arms hanging freely at the sides and wearing light clothing [38]. Weight will be recorded to the nearest 0.1 kg using a digital scale (GLC-D-200 KG digital body scale, GreenLife Canada). Height will be measured with stadiometers to the nearest completed 0.1 cm, with the participant standing with the feet together, without shoes, and the heels, buttocks and upper part of the back projected on the same vertical plane, with the head oriented on the plane of Frankfurt [38]. Waist circumference will be measured at the navel level using a measuring tape to the nearest completed 0.1 cm [38]. The patient will be instructed to breathe normally, and the measurement will be taken at the end of a normal expiration. BMI will be calculated as weight in kg divided by height squared (m2), and obesity will be defined as a BMI ≥30 kg/m2 [39]. Central obesity will be defined as a waist circumference ≥102 cm for men or ≥88 cm for women [40] and [42]. A wealth index score will be generated using principal components analysis of items owned [43]. Data capture, management, and analysis We will capture household-level and individual-level data using electronic questionnaires preloaded into the Open Data Kit (ODK) Collect app on an Android mobile device. These mobile devices will be encrypted and password-protected. For each household on the sampling list, a unique household identifier will be generated, barcoded, and uploaded into the ODK. Additional household infor- mation obtained from GSS, including the structure number, house number, subjects’ names, telephone number, and address, will also be uploaded in the ODK and used to identify a selected household. The household head will then confirm whether the infor- mation about his/her household is correct. If correct, the same unique household identifier will be applied to all members of the same household. Household and individual-level data will be collected separately GLOBAL HEALTH ACTION 5 Table 1. List of measures included in the survey, with operational definitions, rationale, level of measurement (household or individual) and tools used. Measure Operational definition Rationale Household or individual level measure Tool used Household characteristics Household membership, occupation of household head, household asset ownership, household water and sanitation details, household fuel use, size, financial hardship To characterise the sampled household Household Adapted from Ghana Demographic & Health Survey [44] Individual characteristics Age, sex, religion, ethnic group, education, occupation, marital status To characterise the sampled individuals Individual Adapted from Ghana Demographic & Health Survey [44] Social cohesion and trust Broad concept spanning community sense of belonging, trust in the community, sense of obligation to help others and confidence in return of assistance, equality with community members, and community networks. To understand aspects of social cohesion and trust and associations with health behaviours and disease outcomes (Objective 4) Individual Urban Health and Poverty Survey [45] Medical history related to the professional diagnosis of the main NCDs (Heart Disease (Angina, Abnormal Heart Rhythm), Stroke, Chronic Lung Disease (Chronic Bronchitis or Emphysema), Hypertension, Cancer, Asthma, Arthritis, Kidney Disease, Liver Disease, High Blood Cholesterol, Obesity) Medical history based on self- report of a diagnosis of condition by a medical professional. To estimate prevalence of major non-communicable diseases and common risk factors (Objectives 1 & 2). Individual WHO STEPwise tool [46] Global Physical Activity Questionnaire (GPAQ) [48] Risk behaviours including tobacco use alcohol consumption, and physical inactivity. Physical activity refers to all movement including during leisure time, for transport to get to and from places, or as part of a person’s work. Diet quality Consumption of different food groups, i.e. sets of foods that share similar nutritional properties or biological or culinary characteristics. To understand dietary practices and quality as a major risk factor for NCDS (Objective 2) Individual Diet Quality Questionnaire [47] Self-rated health Perceived health status based on a scale of 0 (worst health) to 100 (perfect health). To understand perceived health status as a risk factor and/or consequence of health behaviours and outcomes. Individual Score from 0 to 100 Quality of Life An individual’s perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards, and concerns. To understand associations between quality of life and NCD risk and disease. Quality of life may be a risk for or consequence of diabetes and other NCDs. Individual World Health Organisation Quality of Life (WHOQOL- BREF) [41] Social Support The number of close confidants, sense of concern from other people, and relationships with neighbours, with a focus on the accessibility of practical help. To understand the social context and associations with diabetes and other NCD outcomes and risks. (Objective 4) Individual Oslo Social Support Scale (OSSS-3) [49] Personal stress Extent to which events in a person’s life are assessed as stressful, unpredictable, and uncontrollable. To understand associations between health, behaviours, and perceived personal stress as a possible risk factor for or consequence of ill health. Individual Perceived Stress Scale (PSS-10) [50] Psychological distress A measure of stress, anxiety, and depressive symptoms. To understand associations between health, behaviours, and psychological wellbeing as a possible risk factor for or consequence of ill health. Individual Psychological Distress Scale (PDS) developed and used in the Urban Health and Poverty Survey (EDULINK Wave III) survey [45] (Continued ) 6 S. A. LULE ET AL. on different ODK questionnaires for members of the same household. Collected data will be uploaded reg- ularly onto a dedicated secure server for storage, cleaning, coding, and anonymisation. When a selected household cannot be located or correctly identified (e.g. identification data on the sampling list does not match the information pro- vided by the participants) or the participant refuses or discontinues participation, the enumerators will not proceed with data collection but move to locate and identify the next household on the sampling list. Specific analysis plans to address the objectives of the CARE Diabetes project will be described else- where, and we refrain from defining variables as exposures or outcomes in this study design paper in recognition that 1) a single variable may have various roles in subsequent analyses to understand the com- plex inter-relationships between contextual factors and health and 2) the cross-sectional design of our survey hinders assessment of cause and effect implied by exposure and outcome labels assigned at the design stage. Broadly, analysis will entail a description of study population characteristics sum- marised as frequencies and percentages for categori- cal variables and means with standard deviation or median with 25th and 75th percentile for continuous variables, depending on the nature of the distribu- tion. Chi-square tests will be used for comparison between categorical variables, and we will use para- metric or non-parametric tests such as the t-test or Wilcoxon-Mann-Whitney test to test differences between continuous variables, depending on data dis- tribution as appropriate. We will use logistic and linear regression models to further elucidate associa- tions between variables, controlling for potential con- founding and effect modification as appropriate and such analyses will be informed by theoretical frame- works and specified in subsequent papers. All ana- lyses will account for the survey design and unequal probability sampling methods applied. Missing data will be treated as missing, without imputation. Data outliers will be identified on the basis of plausibility Table 1. (Continued). Measure Operational definition Rationale Household or individual level measure Tool used Diabetes knowledge, diabetes- related behaviours, and diabetes-related consequences Knowledge and awareness of the causes, signs/symptoms, consequences, and ways to prevent/control diabetes; self- reported history of diabetes testing and/or diagnosis of diabetes; care-seeking self- reported diabetes-related complications among individuals living with a diagnosis of diabetes To describe population awareness and knowledge of diabetes and, for those living with the disease, their care-seeking behaviours, and self-reported complications of diabetes. Individual Questions developed by the study team and adapted from the Bangladesh DMagic study tools [53] Appraisal of diabetes among those living with a diagnosis Perceptions of one’s ability to control their diabetes and its impacts on life goals. To understand an individual’s thoughts about coping with a diagnosis of diabetes. This will provide insight into the consequences of diabetes in the study context. Individual Appraisal of Diabetes Scale [51] Self-management of diabetes Perceived self-efficacy of patients to self-manage their diabetes To understand an individual’s perception of their ability to manage their diabetes through behaviours, medication, etc. within the study context. Individual Diabetes Empowerment Scale Short Form (DES- SF) [52] Care-seeking and costs of care seeking Self-reported care-seeking and associated costs related to an NCD To understand care-seeking behaviours and economic consequences of diabetes and other NCDs. (Objective 3) Individual Questions developed by the study team. Weight, height, and waist circumference Absolute measures to the nearest 0.1 cm for height and waist circumference, and to the nearest 0.1 kg for weight. To measure adiposity. Obesity will be defined as BMI (weight/ height2)>30. Central obesity will be defined as a waist circumference ≥102 cm for men or ≥88 cm for women or a waist-for-height ratio > 0.5. (Objectives 1 & 2) Individual Measuring tape & weighing scales Blood pressure Diastolic and systolic blood pressure in mmHg To measure blood pressure (Objectives 1 & 2) Individual Digital blood pressure monitor Blood glucose Random blood glucose in mmol/l To estimate risk of diabetes where glucose concentration ≥11.1 mmol/L indicates diabetes. (Objectives 1 & 2) Individual Digital point-of care glucometer GLOBAL HEALTH ACTION 7 and probability and any that cannot be corrected will be re-coded as missing values. Quality control and validation of the information Staff for this survey will be trained using SOPs to conduct various procedures, including measurement of BP and anthropometric parameters, consenting, and data collection. Data will be entered directly in ODK on Android devices. The ODK form will be designed with con- straints, logic and consistency checks to ensure data accuracy and completeness. Field team leaders will coordinate and supervise data collection and quality checks. Data cleaning will be conducted to ensure a suitable dataset is available for analysis. Pilot testing Pilot testing of the survey tools and procedures will be conducted among 50 households selected at ran- dom by the GSS in the La municipal area of Accra. The same selection criteria will be used for the inclu- sion and exclusion of participants in the pilot study. Field procedures and data processes will be modified to address any challenges identified in the pilot test and to maximise data quality in the full survey. The time required to complete a home visit will be esti- mated. Data from the pilot study will not be included in the survey data and will not be considered for data analysis. Expected outcomes The survey will estimate the prevalence of diabetes, hypertension, overweight and obesity, self-reported NCDs and major NCD risks in Ga Mashie. Analyses will identify important associations between socio- demographic, contextual and physical parameters and risk of diabetes and other NCDs. The evidence generated will help build a detailed understanding of the context, socio-cultural and economic drivers, and consequences of diabetes and NCD risk in Accra, including associations with quality of life and health- care expenditure. This survey will map the local area to further enhance our understanding of how the physical environment in terms of the commercial, recrea- tional, and social use of space, and perceptions of security can impact diabetes, NCDs and associated risk factors. Through community engagement initiatives throughout the project and subsequent sharing of study findings with the community, it is anticipated that this project will contribute to community and stakeholder capacity to understand health in this population and organise and advocate for initiatives to prevent and control diabetes and other NCDs. Public involvement The Ga Mashie Development Agency (GAMADA) and the local chief’s council are leading governance organi- sations within the community of Ga Mashie. GAMADA is an organisation tasked with leading development processes in the two communities that form Old Accra. Approval from these organisations and stakeholders is needed before any research engage- ment can happen in the community. The CARE project will collaborate with GAMADA, the local chief’s coun- cil and the Ghana NCD Alliance, an NGO involved in NCD advocacy. Various stakeholders have been con- sulted during protocol development and will have opportunities to engage throughout the project. A community orientation meeting (known locally as a durbar) was hosted by GAMADA on 27 August 2022 to formally introduce the CARE diabetes project to the two study communities, James Town and Ussher Town. This was necessary to ensure that the CARE diabetes project activities aligned with the general development goals of the communities. A broad profile of community mem- bers attended the community engagement activity, including groups of young people from local box- ing clubs and from a local NGO focused on youth development through basketball, and older people from the James Town Health Club (an initiative originating from several years of work by the research team in the community). Many commu- nity leaders graced the programme, including chiefs, fishermen, and market leaders. Two repre- sentatives from the community’s main public hos- pital (Ussher Polyclinic) also participated. Discussion We have described the design of a cross-sectional survey to quantify the prevalence of diabetes and other major NCDs and risk factors, care seeking, and the social and contextual factors that are asso- ciated with diabetes in a poor urban community in Ghana. This is part of the larger CARE Diabetes project, which seeks to apply transdisciplinary approaches to understand how context influences the burden of diabetes and its consequences in order to develop context-specific intervention strate- gies. This addresses data gaps on contextual factors driving prevalence, management, and control of dia- betes and other NCDs in urban Africa, and our find- ings will inform the development and evaluation of interventional studies on diabetes and other NCDs in the study setting and elsewhere. 8 S. A. LULE ET AL. The large, population-based random-sample design using objective measures of blood glucose, blood pressure and anthropometry, and standardised tools for measurement of social, behavioural, and contextual factors are major strengths of our design. Nevertheless, our study design reflects a compromise between the precision of measurements and feasibil- ity of data collection in a population-based survey in a densely populated, poor urban context. For exam- ple, we will use random plasma glucose (RPG) to test for diabetes in this population instead of the more sensitive approach of fasting plasma glucose (FPG) on its own or combined with an oral glucose toler- ance test (OGTT), which would also allow us to identify instances of impaired fasting glucose and impaired glucose tolerance – stages of intermediate hyperglycaemia associated with increased risk of dia- betes. This decision is based on the impracticalities of ensuring fasting in our study sample and the exces- sive time demands required for OGTT, which demands repeat blood glucose testing two-hours after an oral glucose load. Specifically, FPG in popu- lation-based surveys requires multiple contacts with participants who need to be briefed to abstain from all food and drink, except water, for at least eight hours, and requires enumerators to take measures early in the morning before the fast is broken – a time when the majority of our study population will be engaged in commercial activities. Further, the use of FPG and OGTT increases the duration of data collection substantially and would double the number of blood samples that need to be taken, with implica- tions for participants and project resources. Tests would need to be rescheduled if participants failed to abstain from food and drinks, and it is likely that the approach would increase non-compliance, refusal or withdrawal from the survey. The RPG is a simple, low-cost, and quick proce- dure that can be done at any time of day and can be completed in a single contact with the participant at their home, with results available immediately. RPG can be influenced by time of test and time since last meal – details which we will record in our survey and will use in interpreting our data. So, whilst RPG is not suitable as a clinical diagnostic test for diabetes, it is a practical tool for epidemiological description of diabetes risk in a population where random plasma glucose levels ≥11.1 mmol/L will be interpreted as screen-positive for diabetes [3,33]. Study participants will be informed that the RPG test will not provide a diagnosis of diabetes, and participants with higher- than-expected RPG levels (≥6.1 mmol/L) will be referred for further assessment at the Ussher Town Polyclinic or Korle-Bu Teaching Hospital. Alternative methods such as HbA1c, dry blood spots or venous blood sampling for laboratory analysis were not con- sidered viable in the study context. A further limitation of our study design is that several of the parameters measured through our survey rely on self-reported behaviours, medical history, and knowledge. Though we use many standardised and previously validated tools in our survey, there is poten- tial for recall and reporting bias in data gathered in this way. Internal consistency, range and logic checks in our data collection tools will help to identify any obviously spurious responses, but many may be undetectable. Enumerator training, community engagement, as well as our participant information and consent forms, will emphasise confidentiality and the intended use of the data, which may discourage deliberately false responses. Nevertheless, interpretation of all data should be aware of the inherent limitations of the methods used. Acknowledgments The authors thank Dr Lucy Twumwaah from the Ghana Statistical Services for conducting the sampling and provi- sion of the map of the study area and the Ga Mashie Development Authority (GAMADA) for the support offered during the survey preparation. Author contributions All authors contributed towards the design and implemen- tation of the study. LS led the drafting of the manuscript, supported by SBK. The rest of the authors reviewed the drafts, and read and approved the final manuscript. EF, DA, KK and AdGA provided oversight of the project study design and manuscript writing. Disclosure statement No potential conflict of interest was reported by the author(s). Ethics and consent Ethical approval for the CARE project has been obtained from the Ghana Health Service (GHS-ERC:017/02/22); Noguchi Memorial Institute for Medical Research Institutional Review Board, University of Ghana (NMIMR-IRB CP 060/21–22); and the Research Ethics Committee at University College London (ID:21541/001). Participants will provide written informed consent. Findings will be dissemi- nated at relevant conferences, community durbars, stake- holder meetings and through peer-reviewed journals. The project will stay consistent with the methodology submitted for ethics approval. Funding information The work was supported by the Medical Research Council (MRC) through the United Kingdom Research and Innovation (UKRI), grant number MR/T029919/1. The funder has no role in the study design and conduct of this study.The CARE project is conducted by the University of Ghana in collaboration with University GLOBAL HEALTH ACTION 9 College London and the Universities of York, Melbourne, and Greenwich. Paper context The CARE diabetes project is a transdisciplinary study aiming to generate a contextual understanding of diabetes in urban poor communities in Ghana. The CARE diabetes study seeks to provide relevant information to identify opportunities for community-based intervention strategies for diabetes preven- tion, management, and control in urban poor communities in Ghana. Given the cross-sectional design of the survey, the temporality of events between diabetes and assessed factors cannot be established. ORCID Edward Fottrell http://orcid.org/0000-0003-0518-7161 References [1] Harreiter J, Roden M. Diabetes mellitus: definition, classification, diagnosis, screening and prevention (Update 2023). 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LULE ET AL. https://doi.org/10.1093/heapol/czl029 https://doi.org/10.1371/journal.pone.0202818 https://extranet.who.int/ncdsmicrodata/index.php/catalog/630 https://extranet.who.int/ncdsmicrodata/index.php/catalog/630 http://www.dietquality.org https://www.who.int/publications/m/item/global-physical-activity-questionnaire https://www.who.int/publications/m/item/global-physical-activity-questionnaire https://doi.org/10.1007/s00127-006-0051-5 https://doi.org/10.1007/s00127-006-0051-5 https://doi.org/10.1111/j.1559-1816.2012.00900.x https://doi.org/10.1007/BF00844767 https://doi.org/10.2337/diacare.26.5.1641-a https://doi.org/10.1136/bmjgh-2018-000787 https://doi.org/10.1136/bmjgh-2018-000787 Abstract Introduction The CARE project aim The CARE survey objectives Methods Study design, setting and population Study participant inclusion and exclusion criteria Sample size and sampling methods Preparations Survey team Consent Procedures Data capture, management, and analysis Quality control and validation of the information Pilot testing Expected outcomes Public involvement Discussion Acknowledgments Author contributions Disclosure statement Ethics and consent Funding Paper context References