Sociodemographic characteristics and COVID-19 testing rates: spatiotemporal patterns and impact of test accessibility in Sweden.

BACKGROUND: Diagnostic testing is essential for disease surveillance and test-trace-isolate efforts. We aimed to investigate if residential area sociodemographic characteristics and test accessibility were associated with Coronavirus Disease 2019 (COVID-19) testing rates. METHODS: We included 426 224 patient-initiated COVID-19 polymerase chain reaction tests from Uppsala County in Sweden from 24 June 2020 to 9 February 2022. Using Poisson regression analyses, we investigated if postal code area Care Need Index (CNI; median 1.0, IQR 0.8-1.4), a composite measure of sociodemographic factors used in Sweden to allocate primary healthcare resources, was associated with COVID-19 daily testing rates after adjustments for community transmission. We assessed if the distance to testing station influenced testing, and performed a difference-in-difference-analysis of a new testing station targeting a disadvantaged neighbourhood. RESULTS: We observed that CNI, i.e. primary healthcare need, was negatively associated with COVID-19 testing rates in inhabitants 5-69 years. More pronounced differences were noted across younger age groups and in Uppsala City, with test rate ratios in children (5-14 years) ranging from 0.56 (95% CI 0.47-0.67) to 0.87 (95% CI 0.80-0.93) across three pandemic waves. Longer distance to the nearest testing station was linked to lower testing rates, e.g. every additional 10 km was associated with a 10-18% decrease in inhabitants 15-29 years in Uppsala County. The opening of the targeted testing station was associated with increased testing, including twice as high testing rates in individuals aged 70-105, supporting an intervention effect. CONCLUSIONS: Ensuring accessible testing across all residential areas constitutes a promising tool to decrease inequalities in testing.

Food environment interactions after migration: a scoping review on low- and middle-income country immigrants in high-income countries.

OBJECTIVE: To map and characterise the interactions between the food environment and immigrant populations from low- and middle-income countries living in high-income countries. DESIGN: A scoping review was carried out following the framework outlined by Arksey and O'Malley, as well as Levac et al. Peer-reviewed studies in English published between 2007 and 2021 were included. Two reviewers screened and selected the papers according to predefined inclusion criteria and reporting of results follows the PRISMA-ScR guidelines. A 'Best fit' framework synthesis was carried out using the Analysis Grid for Environments Linked to Obesity (ANGELO) framework. SETTING: High-income countries. PARTICIPANTS: Immigrants from low- and middle-income countries. RESULTS: A total of sixty-eight articles were included, primarily based in the USA, as well as Canada, Australia and Europe, with immigrants originating from five regions of the globe. The analysis identified three overarching themes that interconnected different aspects of the food environment in addition to the four themes of the ANGELO framework. They demonstrate that in valuing fresh, healthy and traditional foods, immigrants were compelled to surpass barriers in order to acquire these, though children's demands, low incomes, time scarcity and mobility influenced the healthiness of the foods acquired. CONCLUSION: This study brought together evidence on interactions between immigrant populations and the food environment. Immigrants attempted to access fresh, traditional, healthier food, though they faced structural and family-level barriers that impacted the healthiness of the food they acquired. Understanding the food environment and interactions therein is key to proposing interventions and policies that can potentially impact the most vulnerable.

Motivational determinants of physical activity in disadvantaged populations with (pre)diabetes: a cross-cultural comparison.

BACKGROUND: Understanding motivational determinants of physical activity (PA) is essential to guide the implementation of PA at individual and population level. Knowledge about the cross-cultural generalizability of these determinants is lacking and they have mostly been studied as separate factors. This study compares a motivational process model across samples from diverse populations with, or at risk of diabetes. METHODS: Measurement invariance of barrier identified regulation, barrier self-efficacy and social support was assessed in a rural Ugandan sample (n = 712) and disadvantaged samples with high proportions of immigrants in urban South Africa (n = 566) and Sweden (n = 147). These motivational determinants were then compared through multigroup structural equation modeling. RESULTS: The studied motivational constructs showed scalar invariance. Latent mean levels of perceived social support and barrier self-efficacy were lower in South Africa and Sweden. Structural models (for different PA outcomes) were not consistent across settings except for the association between perceived social support and identified regulation. Identified regulation was only associated with vigorous PA in Uganda and with moderate PA in South Africa. The association between social support and PA outcomes ranged from weak to not significant and the association between self-efficacy and PA was not significant. Self-reported PA was highest in Uganda and lowest in Sweden. Self-reported vigorous PA was significantly related to lower hemoglobin A1c levels, while moderate PA was not. CONCLUSIONS: Findings suggest that: 1) it is feasible to compare a motivational process model across diverse settings; 2) there is lower perceived social support and self-efficacy in the urban, migrant samples; 3) identified regulation is a more promising determinant of PA than self-efficacy or social support in these populations; 4) associations between motivational determinants and PA depend on the perceived type and/or intensity of PA; 5) perceived relatedness functions as a basic psychological need across diverse settings; and 6) people's perception of the PA they perform depends on their perceived level of intensity of PA which would have major implications for health promotion.

Dietary patterns and practices in rural eastern Uganda: Implications for prevention and management of type 2 diabetes.

BACKGROUND: The burden of type 2 diabetes in Sub-Saharan Africa is projected to double by 2040, partly attributable to rapidly changing diets. In this paper, we analysed how community members in rural Uganda understood the concept of a healthy or unhealthy diet, food preparation and serving practices to inform the process of facilitating knowledge and skill necessary for self-management and care for type 2 diabetes. This was a qualitative study involving 20 focus group discussions and eight in-depth interviews among those at risk, patients with type 2 diabetes and the general community members without diabetes mellitus. Data was coded and entered into Atlas ti version 7.5.12 and interpreted using thematic analysis. We identified three main themes, which revealed, the perceptions on food and diet concerning health; the social dimensions of food and influence on diet practices; and food as a gendered activity. Participants noted that eating and cooking practices resulted in unhealthy diets. Their practices were affected by beliefs, poverty and food insecurity. Women determined which foods to prepare, but men prepared only some of the foods such as delicacies like a rice dish "pilau." New commercial and processed foods were increasingly available and consumed even in rural areas. Participants linked signs and symptoms of illness to diet as they narrated changes from past to current food preparation behaviours. Their view of overweight and obesity was also gendered and linked to social status. Participants' perception of disease influenced by diet was similar among those with and without type 2 diabetes, and those at risk. People described what is a healthy diet was as recommended by the health workers, but stated that their practices differed greatly from their knowledge. There was high awareness about healthy and balanced diets, but food is entrenched within social and gendered paradigms, which are slowly changing. Social and gender dimensions of food will need to be addressed through interventions in communities to promote change on a society level.

Cultural adaptation of a peer-led lifestyle intervention program for diabetes prevention in India: the Kerala diabetes prevention program (K-DPP).

BACKGROUND: Type 2 diabetes mellitus (T2DM) is now one of the leading causes of disease-related deaths globally. India has the world's second largest number of individuals living with diabetes. Lifestyle change has been proven to be an effective means by which to reduce risk of T2DM and a number of "real world" diabetes prevention trials have been undertaken in high income countries. However, systematic efforts to adapt such interventions for T2DM prevention in low- and middle-income countries have been very limited to date. This research-to-action gap is now widely recognised as a major challenge to the prevention and control of diabetes. Reducing the gap is associated with reductions in morbidity and mortality and reduced health care costs. The aim of this article is to describe the adaptation, development and refinement of diabetes prevention programs from the USA, Finland and Australia to the State of Kerala, India. METHODS: The Kerala Diabetes Prevention Program (K-DPP) was adapted to Kerala, India from evidence-based lifestyle interventions implemented in high income countries, namely, Finland, United States and Australia. The adaptation process was undertaken in five phases: 1) needs assessment; 2) formulation of program objectives; 3) program adaptation and development; 4) piloting of the program and its delivery; and 5) program refinement and active implementation. RESULTS: The resulting program, K-DPP, includes four key components: 1) a group-based peer support program for participants; 2) a peer-leader training and support program for lay people to lead the groups; 3) resource materials; and 4) strategies to stimulate broader community engagement. The systematic approach to adaptation was underpinned by evidence-based behavior change techniques. CONCLUSION: K-DPP is the first well evaluated community-based, peer-led diabetes prevention program in India. Future refinement and utilization of this approach will promote translation of K-DPP to other contexts and population groups within India as well as other low- and middle-income countries. This same approach could also be applied more broadly to enable the translation of effective non-communicable disease prevention programs developed in high-income settings to create context-specific evidence in rapidly developing low- and middle-income countries. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry: ACTRN12611000262909 . Registered 10 March 2011.

Balancing expectations amidst limitations: the dynamics of food decision-making in rural Kerala.

BACKGROUND: Food decision-making is a complex process and varies according to the setting, based on cultural and contextual factors. The study aimed to understand the process of food decision-making in households in rural Kerala, India, to inform the design of a dietary behaviour change intervention. METHODS: Three focus group discussions (FGDs) and 17 individual interviews were conducted from September 2010 to January 2011 among 13 men and 40 women, between 23 and 75 years of age. An interview guide facilitated the process to understand: 1) food choices and decision-making in households, with particular reference to access; and 2) beliefs about foods, particularly fruits, vegetables, salt, sugar and oil. The interviews and FGDs were transcribed verbatim and analysed using qualitative content analysis. RESULTS: The analysis revealed one main theme: 'Balancing expectations amidst limitations' with two sub-themes: 'Counting and meeting the costs'; and 'Finding the balance'. Food decisions were made at the household level, with money, time and effort costs weighed against the benefits, estimated in terms of household needs, satisfaction and expectations. The most crucial decisional point was affordability in terms of money costs, followed by food preferences of husband and children. Health and the risk of acquiring chronic diseases was not a major consideration in the decision-making process. Foods perceived as essential for children were purchased irrespective of cost, reportedly owing to the influence of food advertisements. The role of the woman as the homemaker has gendered implications, as the women disproportionately bore the burden of balancing the needs and expectations of all the household members within the available means. CONCLUSIONS: The food decision-making process occurred at household level, and within the household, by the preferences of spouse and children, and cost considerations. The socio-economic status of households was identified as limiting their ability to manoeuvre this fine balance. The study has important policy implications in terms of the need to raise public awareness of the strong link between diet and chronic non-communicable diseases.

Conceptual model for dietary behaviour change at household level: a 'best-fit' qualitative study using primary data.

BACKGROUND: Interventions having a strong theoretical basis are more efficacious, providing a strong argument for incorporating theory into intervention planning. The objective of this study was to develop a conceptual model to facilitate the planning of dietary intervention strategies at the household level in rural Kerala. METHODS: Three focus group discussions and 17 individual interviews were conducted among men and women, aged between 23 and 75 years. An interview guide facilitated the process to understand: 1) feasibility and acceptability of a proposed dietary behaviour change intervention; 2) beliefs about foods, particularly fruits and vegetables; 3) decision-making in households with reference to food choices and access; and 4) to gain insights into the kind of intervention strategies that may be practical at community and household level. The data were analysed using a modified form of qualitative framework analysis, which combined both deductive and inductive reasoning. A priori themes were identified from relevant behaviour change theories using construct definitions, and used to index the meaning units identified from the primary qualitative data. In addition, new themes emerging from the data were included. The associations between the themes were mapped into four main factors and its components, which contributed to construction of the conceptual model. RESULTS: Thirteen of the a priori themes from three behaviour change theories (Trans-theoretical model, Health Belief model and Theory of Planned Behaviour) were confirmed or slightly modified, while four new themes emerged from the data. The conceptual model had four main factors and its components: impact factors (decisional balance, risk perception, attitude); change processes (action-oriented, cognitive); background factors (personal modifiers, societal norms); and overarching factors (accessibility, perceived needs and preferences), built around a three-stage change spiral (pre-contemplation, intention, action). Decisional balance was the strongest in terms of impacting the process of behaviour change, while household efficacy and perceived household cooperation were identified as 'markers' for stages-of-change at the household level. CONCLUSIONS: This type of framework analysis made it possible to develop a conceptual model that could facilitate the design of intervention strategies to aid a household-level dietary behaviour change process.

Prevalence and social determinants of anxiety and depression among adults in Ghana: a systematic review and meta-analysis protocol.

INTRODUCTION: Anxiety and depression pose a significant global health challenge, especially affecting adults in low-income and middle-income countries. In many low-income and middle-income countries, including those in sub-Saharan Africa, social determinants such as access to affordable health services, conflict, food insecurity, and poverty may be associated with the prevalence of anxiety and depression, further contributing to health disparities. To mitigate the burden of anxiety and depression in sub-Saharan Africa, it is essential to develop country-level tailored mental health policies and strategies. For example, Ghana is working towards improving mental health via its 12 year Mental Health policy launched in 2021. However, the prevalence of anxiety and depression among adults in Ghana, along with associated social determinants remains largely unknown, posing challenges for mental health planning, resource allocation and developing targeted interventions. This systematic review seeks to (1) examine the prevalence of anxiety and depression among adults in Ghana and (2) explore social determinants potentially associated with anxiety and depression. METHODS AND ANALYSIS: Electronic databases (eg, African Index Medicus, CINAHL, EMBASE, MEDLINE, and PsycINFO) will be searched with all screening steps conducted by two independent reviewers. Secondary search strategies, including grey literature searches, will be used. Studies reporting on the prevalence of anxiety, depression and/or a combined symptom measure (ie, psychological distress) among adults in Ghana, using validated instruments will be included. If data allows, random-effects-meta-analyses will be performed to estimate pooled prevalence rates of anxiety and depression. Potential clinical and methodological moderators will be examined using subgroup analyses and meta-regression. A narrative synthesis will explore social determinants potentially associated with anxiety and depression among adults in Ghana. ETHICS AND DISSEMINATION: Ethical approval is not required as no primary data will be collected. Results will be disseminated via a peer-reviewed publication and presentations at academic conferences. Plain language summaries will be provided to relevant non-governmental organisations working in Ghana. PROSPERO REGISTRATION NUMBER: CRD42023463078.

Correction: Prevention and management of type 2 diabetes mellitus in Uganda and South Africa: Findings from the SMART2D pragmatic implementation trial.

[This corrects the article DOI: 10.1371/journal.pgph.0000425.].

Smoking cessation among diabetes patients: results of a pilot randomized controlled trial in Kerala, India.

BACKGROUND: India has the second largest diabetic population (61 million) and tobacco users (275 million) in the world. Data on smoking cessation among diabetic patients are limited in low and middle income countries. The objective of the study was to document the effectiveness of diabetic specific smoking cessation counseling by a non-doctor health professional in addition to a cessation advice to quit, delivered by doctors. METHODS: In our parallel-group randomized controlled trial, we selected 224 adult diabetes patients aged 18 years or older who smoked in the last month, from two diabetes clinics in South India. Using a computer generated random sequence with block size four; the patients were randomized equally into intervention-1 and intervention-2 groups. Patients in both groups were asked and advised to quit smoking by a doctor and distributed diabetes specific education materials. The intervention-2 group received an additional diabetes specific 30 minutes counseling session using the 5As (Ask, Advise, Assess, Assist and Arrange), and 5 Rs (Relevance, Risks, Rewards, Roadblocks and Repetition) from a non-doctor health professional. Follow up data were available for 87.5% of patients at six months. The Quit Tobacco International Project is supported by a grant from the Fogarty International Centre of the US National Institutes of Health (RO1TW005969-01).The primary outcomes were quit rate (seven day smoking abstinence) and harm reduction (reduction of the number of cigarettes / bidis smoked per day > 50% of baseline use) at six months. RESULTS: In the intention to treat analysis, the odds for quitting was 8.4 [95% confidence interval (CI): 4.1-17.1] for intervention-2 group compared to intervention-1 group. Even among high level smokers the odds of quitting was similar. The odds of harm reduction was 1.9 (CI: 0.8-4.1) for intervention-2 group compared to intervention-1 group. CONCLUSIONS: The value addition of culturally sensitive diabetic specific cessation counseling sessions delivered by non-doctor health professional was an impressive and efficacious way of preventing smoking related diabetic complications. TRIAL REGISTRATION: Clinical Trial Registry of India (CTRI/2012/01/002327).

Lifestyle change in Kerala, India: needs assessment and planning for a community-based diabetes prevention trial.

BACKGROUND: Type 2 Diabetes Mellitus (T2DM) has become a major public health challenge in India. Factors relevant to the development and implementation of diabetes prevention programmes in resource-constrained countries, such as India, have been under-studied. The purpose of this study is to describe the findings from research aimed at informing the development and evaluation of a Diabetes Prevention Programme in Kerala, India (K-DPP). METHODS: Data were collected from three main sources: (1) a systematic review of key research literature; (2) a review of relevant policy documents; and (3) focus groups conducted among individuals with a high risk of progressing to diabetes. The key findings were then triangulated and synthesised. RESULTS: Prevalence of risk factors for diabetes is very high and increasing in Kerala. This situation is largely attributable to rapid changes in the lifestyle of people living in this state of India. The findings from the systematic review and focus groups identified many environmental and personal determinants of these unhealthy lifestyle changes, including: less than ideal accessibility to and availability of health services; cultural values and norms; optimistic bias and other misconceptions related to risk; and low expectations regarding one's ability to make lifestyle changes in order to influence health and disease outcomes. On the other hand, there are existing intervention trials conducted in India which suggests that risk reduction is possible. These programmes utilize multi-level strategies including mass media, as well as strategies to enhance community and individual empowerment. India's national programme for the prevention and control of major non-communicable diseases (NCD) also provide a supportive environment for further community-based efforts to prevent diabetes. CONCLUSION: These findings provide strong support for undertaking more research into the conduct of community-based diabetes prevention in the rural areas of Kerala. We aim to develop, implement and evaluate a group-based peer support programme that will address cultural and family determinants of lifestyle risks, including family decision-making regarding adoption of healthy dietary and physical activity patterns. Furthermore, we believe that this approach will be feasible, acceptable and effective in these communities; with the potential for scale-up in other parts of India.

Cluster randomised controlled trial of a peer-led lifestyle intervention program: study protocol for the Kerala diabetes prevention program.

BACKGROUND: India currently has more than 60 million people with Type 2 Diabetes Mellitus (T2DM) and this is predicted to increase by nearly two-thirds by 2030. While management of those with T2DM is important, preventing or delaying the onset of the disease, especially in those individuals at 'high risk' of developing T2DM, is urgently needed, particularly in resource-constrained settings. This paper describes the protocol for a cluster randomised controlled trial of a peer-led lifestyle intervention program to prevent diabetes in Kerala, India. METHODS/DESIGN: A total of 60 polling booths are randomised to the intervention arm or control arm in rural Kerala, India. Data collection is conducted in two steps. Step 1 (Home screening): Participants aged 30-60 years are administered a screening questionnaire. Those having no history of T2DM and other chronic illnesses with an Indian Diabetes Risk Score value of ≥60 are invited to attend a mobile clinic (Step 2). At the mobile clinic, participants complete questionnaires, undergo physical measurements, and provide blood samples for biochemical analysis. Participants identified with T2DM at Step 2 are excluded from further study participation. Participants in the control arm are provided with a health education booklet containing information on symptoms, complications, and risk factors of T2DM with the recommended levels for primary prevention. Participants in the intervention arm receive: (1) eleven peer-led small group sessions to motivate, guide and support in planning, initiation and maintenance of lifestyle changes; (2) two diabetes prevention education sessions led by experts to raise awareness on T2DM risk factors, prevention and management; (3) a participant handbook containing information primarily on peer support and its role in assisting with lifestyle modification; (4) a participant workbook to guide self-monitoring of lifestyle behaviours, goal setting and goal review; (5) the health education booklet that is given to the control arm. Follow-up assessments are conducted at 12 and 24 months. The primary outcome is incidence of T2DM. Secondary outcomes include behavioural, psychosocial, clinical, and biochemical measures. An economic evaluation is planned. DISCUSSION: Results from this trial will contribute to improved policy and practice regarding lifestyle intervention programs to prevent diabetes in India and other resource-constrained settings. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry: ACTRN12611000262909.

Catastrophic health expenditure & coping strategies associated with acute coronary syndrome in Kerala, India.

BACKGROUND & OBJECTIVES: India contributes a significant number of deaths attributed to coronary artery disease (CAD) compared to the rest of the world. Data on catastrophic health expenditure (CHE) related to acute coronary syndrome (ACS), the major cause of deaths in CAD, are limited in the literature. We estimated the magnitude of CHE and studied the strategies used to cope with CHE. METHODS: Two hundred and ten ACS patients (mean age 56 yr, 83% men) were randomly selected proportionately from six hospitals in Thiruvananthapuram district, Kerala, India. Information on demographics, ACS-related out-of-pocket expenditure and coping strategies was collected using a pre-tested structured interview schedule. CHE, defined as ACS-related expenditures exceeding 40 per cent of a household's capacity to pay, was estimated using the World Health Organization methods. Health security was defined as protection against out-of-pocket expenditure through an employer or government provided social security scheme. Socio-demographic variables, effect on participants' employment, loans or asset sales for treatment purposes, health security coverage and type of treatment were considered as potential correlates of CHE. Multiple logistic regression analyses were conducted to identify the correlates of CHE. RESULTS: CHE was experienced by 84 per cent (95% CI: 79.04, 88.96) of participants as a consequence of treating ACS. Participants belonging to low socio-economic status (SES) were 15 times (odds ratio (OR): 14.51, 95% CI: 1.69-124.41), whose jobs were adversely affected were seven times (OR: 7.21, CI: 1.54-33.80), who had no health security were six times (OR: 6.00, CI: 2.02-17.81) and who underwent any intervention were three times (OR: 3.24, CI: 1.03-10.16) more likely to have CHE compared to their counterparts. The coping strategies adopted by the participants were loans (41%), savings (14%), health insurance (8%) and a combination of the above (37%). INTERPRETATION & CONCLUSIONS: Our findings show that viable financing mechanism for treating ACS is warranted to prevent CHE particularly among low SES participants, those having no health security, requiring intervention procedures and those with adversely affected employment.

Pathways to catastrophic health expenditure for acute coronary syndrome in Kerala: 'Good health at low cost'?

BACKGROUND: Universal health coverage through the removal of financial and other barriers to access, particularly for people who are poor, is a global priority. This viewpoint describes the many pathways to catastrophic health expenditure (CHE) for patients with Acute Coronary Syndrome (ACS) based on two case studies and the thematic analysis of field notes regarding 210 patients and their households from a study based in Kerala, India. DISCUSSION: There is evidence of the severe financial impact of non-communicable diseases (NCDs), which is in contradiction to the widely acclaimed Kerala model: Good health at low cost. However, it is important to look beyond the out-of-pocket expenditure (OOPE) and CHE to the possible pathways and identify the triggers that make families vulnerable to CHE. The identified pathways include a primary and secondary loop. The primary pathway describes the direct path by which families experience CHE. These include: 1) factors related to the pre-event period that increase the likelihood of experiencing CHE, such as being from the lower socio-economic strata (SES), past financial losses or loans that leave families with no financial shock absorber at the time of illness; 2) factors related to the acute event, diagnosis, treatment and hospitalization and expenditures incurred for the same and; 3) factors related to the post-event period such as loss of gainful employment and means of financing both the acute period and the long-term management particularly through distress financing. The secondary pathway arises from the primary and includes: 1) the impact of distress financing and; 2) the long- and short- term consequences of CHE. These factors ultimately result in a vicious cycle of debt and poverty through non-compliance and repeat acute events. SUMMARY: This paper outlines the direct and indirect pathways by which patients with ACS and their families are trapped in a vicious cycle of debt and poverty. It also contradicts the prevailing impression that only low-income families are susceptible to CHE, distress financing and their aftermaths and underscores the need for a deeper understanding at the micro-level, if Kerala and India as a whole are to undertake the difficult exercise of achieving universal health coverage to successfully tackle its growing NCD burden.

Glycated haemoglobin and fasting plasma glucose tests in the screening of outpatients for diabetes and abnormal glucose regulation in Uganda: A diagnostic accuracy study.

BACKGROUND AND OBJECTIVES: To understand the utility of glycated haemoglobin (HBA1C) in screening for diabetes and Abnormal Glucose Regulation (AGR) in primary care, we compared its performance to that of the fasting plasma glucose (FPG) test. METHODS: This was a prospective diagnostic accuracy study conducted in eastern Uganda. Patients eligible for inclusion were consecutive adults, 30-75 years, receiving care at the outpatient department of a general hospital in eastern Uganda. We determined the sensitivity, specificity and optimum cut-off points for HBA1C and FPG tests using the oral glucose tolerance test (OGTT) as a clinical reference standard. RESULTS: A total of 1659 participants underwent FPG testing of whom 310 were also HBA1C and OGTT tested. A total of 113 tested positive for diabetes and 168 for AGR on the OGTT. At recommended cut-off points for diabetes, the HBA1C and FPG tests had comparable sensitivity [69.8% (95% CI 46.3-86.1) versus 62.6% (95% CI 41.5-79.8), respectively] and specificity [98.6% (95% CI 95.4-99.6) versus 99.4% (95% CI 98.9-99.7), respectively]. Similarly, the sensitivity of HBA1C and the FPG tests for Abnormal Glucose Regulation (AGR) at ADA cut-offs were comparable [58.9% (95% CI 46.7-70.2) vs 47.7% (95% CI 37.3-58.4), respectively]; however, the HBA1C test had lower specificity [70.7% (95% CI 65.1-75.8)] than the FPG test [93.5% (95% CI 88.6-96.4)]. At the optimum cut-offs points for diabetes [45.0 mmol/mol (6.3%) for HBA1C and 6.4 mmol/L (115.2 mg/dl) for FPG], HBA1C and FPG sensitivity [71.2% (95% CI 46.9-87.8) versus 72.7% (95% CI 49.5-87.8), respectively] and specificity [95.1% (95% CI91.8 97.2) versus 98.7% (95% CI 98.0 99.2), respectively] were comparable. Similarly, at the optimum cut-off points for AGR [42.0 mmol/mol (6.0%) for the HBA1C and 5.5 mmol/l (99.0 mg/dl) for the FPG test], HBA1C and FPG sensitivity [42.3% (95% CI 31.8-53.6) and 53.2 (95% CI 43.1-63.1), respectively] and specificity [89.1% (95% CI 84.1 92.7) and 92.7% (95% CI 91.0 94.1), respectively] were comparable. DISCUSSION: HBA1C is a viable alternative diabetes screening and confirmatory test to the FPG test; however, the utility of both tests in screening for prediabetes in this outpatient population is limited.

Application of the Theoretical Framework of Acceptability to assess a telephone-facilitated health coaching intervention for the prevention and management of type 2 diabetes.

BACKGROUND: Lifestyle interventions focusing on diet and physical activity for the prevention and management of type 2 diabetes have been found effective. Acceptance of the intervention is crucial. The Theoretical Framework of Acceptability (TFA) developed by Sekhon et al. (2017) describes the multiple facets of acceptance: Affective attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs and self-efficacy. The aims of this study were to develop and assess the psychometric properties of a measurement scale for acceptance of a telephone-facilitated health coaching intervention, based on the TFA; and to determine the acceptability of the intervention among participants living with diabetes or having a high risk of diabetes in socioeconomically disadvantaged areas in Stockholm. METHODS: This study was nested in the implementation trial SMART2D (Self-management approach and reciprocal learning for type 2 diabetes). The intervention consisted of nine telephone-facilitated health coaching sessions delivered individually over a 6-month period. The acceptability of the intervention was assessed using a questionnaire consisting of 19 Likert scale questions developed using Sekhon's TFA. Exploratory factor analysis (EFA) was performed. RESULTS: Ratings from 49 participants (19 with type 2 diabetes and 30 at high risk of developing diabetes) in ages 38-65 were analyzed. The EFA on the acceptability scale revealed three factors with acceptable reliabilities: affective attitude (alpha 0.90), coherence and understanding (alpha 0.77), perceived burden (alpha 0.85), explaining 82% of the variance. Positive affect and coherence had high median scores and small variance. Median score for perceived burden was low, but with significant variance due to younger individuals and those at high risk reporting higher burden. CONCLUSIONS: The telephone-facilitated health coaching intervention was perceived as acceptable by the study population using a questionnaire based on Sekhon's TFA, with a wider variation in perceived burden seen among high risk and younger participants.

Prevention and management of type 2 diabetes mellitus in Uganda and South Africa: Findings from the SMART2D pragmatic implementation trial.

Health systems in many low- and middle-income countries are struggling to manage type 2 diabetes (T2D). Management of glycaemia via well-organized care can reduce T2D incidence, and associated morbidity and mortality. The primary aim of this study was to evaluate the effectiveness of facility plus community care interventions (integrated care), compared to facility only care interventions (facility care) towards improvement of T2D outcomes in Uganda and South Africa. A pragmatic cluster randomized trial design was used to compare outcomes among participants with T2D and those at high risk. The trial had two study arms; the integrated care arm, and the facility care arm; and in Uganda only, an additional usual care arm. Participants were enrolled at nine primary health facilities in Uganda, and two in South Africa. Participants were adults aged 30 to 75 years, and followed for up to 12 months. Primary outcomes were glycaemic control among participants with T2D, and reduction in HbA1c > = 3 mmol/mol among participants at high risk. Secondary outcomes were retention into care and incident T2D. Adjusted analysis revealed significantly higher retention into care comparing integrated care and facility care versus usual care in Uganda and integrated care versus facility care in South Africa. The effect was particularly high among participants at high risk in Uganda with an incident rate ratio of 2.46 [1.33-4.53] for the facility care arm and 3.52 [2.13-5.80] for the integrated care arm. No improvement in glycaemic control or reduction in HbA1c was found in either country. However, considerable and unbalanced loss to follow-up compromised assessment of the intervention effect on HbA1c. Study interventions significantly improved retention into care, especially compared to usual care in Uganda. This highlights the need for adequate primary care for T2D and suggest a role for the community in T2D prevention. Trial registration number: ISRCTN11913581.

Process evaluation of a pragmatic implementation trial to support self-management for the prevention and management of type 2 diabetes in Uganda, South Africa and Sweden in the SMART2D project.

INTRODUCTION: Type 2 diabetes (T2D) and its complications are increasing rapidly. Support for healthy lifestyle and self-management is paramount, but not adequately implemented in health systems. Process evaluations facilitate understanding why and how interventions work through analyzing the interaction between intervention theory, implementation and context. The Self-Management and Reciprocal Learning for Type 2 Diabetes project implemented and evaluated community-based interventions (peer support program; care companion; and link between facility care and community support) for persons at high risk of or having T2D in a rural community in Uganda, an urban township in South Africa, and socioeconomically disadvantaged urban communities in Sweden. RESEARCH DESIGN AND METHODS: This paper reports implementation process outcomes across the three sites, guided by the Medical Research Council framework for complex intervention process evaluations. Data were collected through observations of peer support group meetings using a structured guide, and semistructured interviews with project managers, implementers, and participants. RESULTS: The countries aligned implementation in accordance with the feasibility and relevance in the local context. In Uganda and Sweden, the implementation focused on peer support; in South Africa, it focused on the care companion part. The community-facility link received the least attention. Continuous capacity building received a lot of attention, but intervention reach, dose delivered, and fidelity varied substantially. Intervention-related and context-related barriers affected participation. CONCLUSIONS: Identification of the key uncertainties and conditions facilitates focus and efficient use of resources in process evaluations, and context relevant findings. The use of an overarching framework allows to collect cross-contextual evidence and flexibility in evaluation design to adapt to the complex nature of the intervention. When designing interventions, it is crucial to consider aspects of the implementing organization or structure, its absorptive capacity, and to thoroughly assess and discuss implementation feasibility, capacity and organizational context with the implementation team and recipients. These recommendations are important for implementation and scale-up of complex interventions. TRIAL REGISTRATION NUMBER: ISRCTN11913581.

Applying systems thinking to identify enablers and challenges to scale-up interventions for hypertension and diabetes in low-income and middle-income countries: protocol for a longitudinal mixed-methods study.

INTRODUCTION: There is an urgent need to reduce the burden of non-communicable diseases (NCDs), particularly in low-and middle-income countries, where the greatest burden lies. Yet, there is little research concerning the specific issues involved in scaling up NCD interventions targeting low-resource settings. We propose to examine this gap in up to 27 collaborative projects, which were funded by the Global Alliance for Chronic Diseases (GACD) 2019 Scale Up Call, reflecting a total funding investment of approximately US$50 million. These projects represent diverse countries, contexts and adopt varied approaches and study designs to scale-up complex, evidence-based interventions to improve hypertension and diabetes outcomes. A systematic inquiry of these projects will provide necessary scientific insights into the enablers and challenges in the scale up of complex NCD interventions. METHODS AND ANALYSIS: We will apply systems thinking (a holistic approach to analyse the inter-relationship between constituent parts of scaleup interventions and the context in which the interventions are implemented) and adopt a longitudinal mixed-methods study design to explore the planning and early implementation phases of scale up projects. Data will be gathered at three time periods, namely, at planning (TP), initiation of implementation (T0) and 1-year postinitiation (T1). We will extract project-related data from secondary documents at TP and conduct multistakeholder qualitative interviews to gather data at T0 and T1. We will undertake descriptive statistical analysis of TP data and analyse T0 and T1 data using inductive thematic coding. The data extraction tool and interview guides were developed based on a literature review of scale-up frameworks. ETHICS AND DISSEMINATION: The current protocol was approved by the Monash University Human Research Ethics Committee (HREC number 23482). Informed consent will be obtained from all participants. The study findings will be disseminated through peer-reviewed publications and more broadly through the GACD network.