ABSTRACT
BACKGROUND: Blood pressure (BP) control among treated patients in Africa is very suboptimal, with low levels of combination therapy use and therapeutic inertia being among the major barriers to effective control of hypertension. The VERONICA-Nigeria study aims to evaluate, among Black African adults with hypertension, the effectiveness and safety of a triple pill-based treatment protocol compared to Nigeria hypertension treatment protocol for the treatment of hypertension. METHODS: This study involves a randomised, parallel-group and open-label trial. Adults with uncontrolled hypertension (n=300), untreated or receiving monotherapy, with no contraindication to study treatments will be randomly assigned 1:1 to treatment with a triple pill based-treatment protocol or Nigeria hypertension treatment protocol. Follow-up is for 6 months, with interim follow up visits at month 1, 2, and 3. In a non-comparative extension treatment period, participants completing the 6 months randomised period and on ≤3 BP-lowering drugs will receive treatment with the triple pill-based treatment protocol for 12 months. The primary outcome is change in home mean SBP from baseline to month 6, and key secondary efficacy outcome is percentage of participants with clinic BP <140/90 mmHg at month 6. The primary safety outcome is discontinuation of trial treatment due to adverse events from randomization to month 6. Economic evaluation will be conducted to assess the cost-effectiveness of the triple pill-based treatment protocol, and process evaluation will be conducted to understand the context in which the trial was conducted, implementation of the trial and interventions and mechanisms of effect, and potential barriers and facilitators to implementing the intervention in clinical practice. CONCLUSION: The VERONICA-Nigeria trial will provide evidence of effectiveness and safety of the triple-based treatment protocol for the pharmacological management of hypertension, in Black African adults. TRIAL REGISTRATION: PACTR202107579572114.
ABSTRACT
AIMS: This study aimed to develop a prediction model for identifying a woman with gestational diabetes mellitus (GDM) at high risk of type 2 diabetes (T2DM) post-birth. METHODS: Utilising data from 1299 women in the Lifestyle Intervention IN Gestational Diabetes (LIVING) study, two models were developed: one for pregnancy and another for postpartum. Key predictors included glucose test results, medical history, and biometric indicators. RESULTS: Of the initial cohort, 124 women developed T2DM within three years. The study identified seven predictors for the antenatal T2DM risk prediction model and four for the postnatal one. The models demonstrated good to excellent predictive ability, with Area under the ROC Curve (AUC) values of 0.76 (95% CI: 0.72 to 0.80) and 0.85 (95% CI: 0.81 to 0.88) for the antenatal and postnatal models, respectively. Both models underwent rigorous validation, showing minimal optimism in predictive capability. Antenatal model, considering the Youden index optimal cut-off point of 0.096, sensitivity, specificity, and accuracy were measured as 70.97%, 70.81%, and 70.82%, respectively. For the postnatal model, considering the cut-off point 0.086, sensitivity, specificity, and accuracy were measured as 81.40%, 75.60%, and 76.10%, respectively. CONCLUSIONS: These models are effective for predicting T2DM risk in women with GDM, although external validation is recommended before widespread application.
Subject(s)
Diabetes Mellitus, Type 2 , Diabetes, Gestational , Life Style , Postpartum Period , Humans , Female , Pregnancy , Diabetes Mellitus, Type 2/prevention & control , Adult , Risk Assessment/methods , Risk Factors , ROC CurveABSTRACT
OBJECTIVES: To explore associations between type and number of abnormal glucose values on antenatal oral glucose tolerance test (OGTT) with postpartum diabetes in South Asian women diagnosed with gestational diabetes (GDM) using International Association of the Diabetes and Pregnancy Study Groups criteria. METHODS: This post-hoc evaluation of the Lifestyle Intervention IN Gestational Diabetes (LIVING) study, a randomized controlled trial, was conducted among women with GDM in the index pregnancy, across 19 centers in Bangladesh, India, and Sri Lanka. Postpartum diabetes (outcome) was defined on OGTT, using American Diabetes Association (ADA) criteria. RESULTS: We report data on 1468 women with GDM, aged 30.9 (5.0) years, and with median (interquartile range) follow-up period of 1.8 (1.4-2.4) years after childbirth following the index pregnancy. We found diabetes in 213 (14.5%) women with an incidence of 8.7 (7.6-10.0)/100 women-years. The lowest incidence rate was 3.8/100 women years, in those with an isolated fasting plasma glucose (FPG) abnormality, and highest was 19.0/100 women years in participants with three abnormal values. The adjusted hazard ratios for two and three abnormal values compared to one abnormal value were 1.73 (95% confidence interval [CI], 1.18-2.54; p = .005) and 3.56 (95% CI, 2.46-5.16; p < .001) respectively. The adjusted hazard ratio for the combined (combination of fasting and postglucose load) abnormalities was 2.61 (95% CI, 1.70-4.00; p < .001), compared to isolated abnormal FPG. CONCLUSIONS: Risk of diabetes varied significantly depending upon the type and number of abnormal values on antenatal OGTT. These data may inform future precision medicine approaches such as risk prediction models in identifying women at higher risk and may guide future targeted interventions.
Subject(s)
Blood Glucose , Diabetes, Gestational , Glucose Tolerance Test , Postpartum Period , Humans , Female , Pregnancy , Diabetes, Gestational/epidemiology , Diabetes, Gestational/diagnosis , Diabetes, Gestational/blood , Adult , Blood Glucose/analysis , Blood Glucose/metabolism , Risk Factors , Incidence , Sri Lanka/epidemiology , India/epidemiology , Bangladesh/epidemiology , Prognosis , Follow-Up StudiesABSTRACT
AIM: To study, the incidence and risk factors for postpartum diabetes (DM), in women with gestational diabetes mellitus (GDM) from South Asia (Bangladesh, India and Sri Lanka), followed for nearly two years after delivery. METHODS: Women with prior GDM diagnosed using IADPSG criteria were invited at 19 centres across Bangladesh, India and Sri Lanka for an oral glucose tolerance test (OGTT) following childbirth, and were enrolled in a randomized controlled trial. The glycaemic category (outcome) was defined from an OGTT based on American Diabetes Association criteria. RESULTS: Participants (n = 1808) recruited had a mean ± SD age of 31.0 ± 5.0 years. Incident DM was identified, between childbirth and the last follow-up, in 310 (17.1 %) women [incidence 10.75/100 person years], with a median follow-up duration of 1.82 years after childbirth. Higher age, lower education status, higher prior pregnancy count, prior history of GDM, family history of DM, and postpartum overweight/obese status were significantly associated with incident DM. Women in Bangladesh had a higher cumulative incidence of DM [16.49/100 person years] than in Sri Lanka [12.74/100 person years] and India [7.21/100 person years]. CONCLUSIONS: A high incidence of DM was found in women with prior GDM in South Asia, with significant variation between countries. Women from Bangladesh had a significantly higher pregnancy count, family history of DM and overweight/obese status, despite having significantly lower age, which could be responsible for their higher rates of DM. Registration of this study: The study was registered with the Clinical Trials Registry of India (CTRI/2017/06/008744), Sri Lanka Clinical Trials Registry (SLCTR/2017/001), and ClinicalTrials.gov (NCT03305939).
Subject(s)
Diabetes, Gestational , Pregnancy , Female , Humans , Adult , Male , Diabetes, Gestational/epidemiology , Diabetes, Gestational/diagnosis , Incidence , Sri Lanka/epidemiology , Bangladesh/epidemiology , Asia, Southern , Overweight , Risk Factors , Postpartum Period , India/epidemiology , ObesityABSTRACT
Background: Child marriage is a serious public health issue with dire implications at the individual and societal level. Almost half of all child marriages globally originate from South Asia. The aim of this study is to identify consistent factors associated with and resulting from child marriage in South Asia through a review of available evidence. Methods: This systematic review adhered to the 2015 Preferred Reporting Items for Systematic review and Meta-Analysis (PRISMA) guidelines. Six computerized bibliographic databases, namely PsycINFO, CINAHL, EMBASE, Ovid Medline, PUBMED, and Scopus were searched. Retrieved studies were exported to EndNote and screened for eligibility using pre-determined criteria. The quality of the included studies was rated using 14 quality appraisal criteria derived from the National Institutes of Health (NIH) Tool. Results: A total of 520 articles were retrieved from six databases. Of these, 13 articles met the eligibility criteria and were included in this study. Factors consistently associated with child marriage in South Asia were rural residence, low level of education, poor economic background, low exposure to mass media and religion (Hindu and Muslim in particular countries). Maternal health care factors resulting from child marriage included: low utilization of antenatal care services, low institutional delivery, and low delivery assistance by a skilled birth attendant. Conclusions: Child marriage results from an interplay of economic and social forces. Therefore, to address the complex nature of child marriage, efforts targeting improvement in education, employment, exposure to health information via mass media, and gender egalitarianism are required. This systematic review was registered with PROSPERO [CRD42020190410].
Subject(s)
Marriage , Maternal Health Services , United States , Child , Humans , Female , Pregnancy , Educational Status , Prenatal Care , AsiaABSTRACT
Importance: Women with recent gestational diabetes (GDM) have increased risk of developing type 2 diabetes. Objective: To investigate whether a resource-appropriate and context-appropriate lifestyle intervention could prevent glycemic deterioration among women with recent GDM in South Asia. Design, Setting, and Participants: This randomized, participant-unblinded controlled trial investigated a 12-month lifestyle intervention vs usual care at 19 urban hospitals in India, Sri Lanka, and Bangladesh. Participants included women with recent diagnosis of GDM who did not have type 2 diabetes at an oral glucose tolerance test (OGTT) 3 to 18 months postpartum. They were enrolled from November 2017 to January 2020, and follow-up ended in January 2021. Data were analyzed from April to July 2021. Interventions: A 12-month lifestyle intervention focused on diet and physical activity involving group and individual sessions, as well as remote engagement, adapted to local context and resources. This was compared with usual care. Main Outcomes and Measures: The primary outcome was worsening category of glycemia based on OGTT using American Diabetes Association criteria: (1) normal glucose tolerance to prediabetes (ie, impaired fasting glucose or impaired glucose tolerance) or type 2 diabetes or (2) prediabetes to type 2 diabetes. The primary analysis consisted of a survival analysis of time to change in glycemic status at or prior to the final patient visit, which occurred at varying times after 12 months for each patient. Secondary outcomes included new-onset type 2 diabetes and change in body weight. Results: A total of 1823 women (baseline mean [SD] age, 30.9 [4.9] years and mean [SD] body mass index, 26.6 [4.6]) underwent OGTT at a median (IQR) 6.5 (4.8-8.2) months postpartum. After excluding 160 women (8.8%) with type 2 diabetes, 2 women (0.1%) who met other exclusion criteria, and 49 women (2.7%) who did not consent or were uncontactable, 1612 women were randomized. Subsequently, 11 randomized participants were identified as ineligible and excluded from the primary analysis, leaving 1601 women randomized (800 women randomized to the intervention group and 801 women randomized to usual care). These included 600 women (37.5%) with prediabetes and 1001 women (62.5%) with normoglycemia. Among participants randomized to the intervention, 644 women (80.5%) received all program content, although COVID-19 lockdowns impacted the delivery model (ie, among 644 participants who engaged in all group sessions, 476 women [73.9%] received some or all content through individual engagement, and 315 women [48.9%] received some or all content remotely). After a median (IQR) 14.1 (11.4-20.1) months of follow-up, 1308 participants (81.2%) had primary outcome data. The intervention, compared with usual care, did not reduce worsening glycemic status (204 women [25.5%] vs 217 women [27.1%]; hazard ratio, 0.92; [95% CI, 0.76-1.12]; P = .42) or improve any secondary outcome. Conclusions and Relevance: This study found that a large proportion of women in South Asian urban settings developed dysglycemia soon after a GDM-affected pregnancy and that a lifestyle intervention, modified owing to the COVID-19 pandemic, did not prevent subsequent glycemic deterioration. These findings suggest that alternate or additional approaches are needed, especially among high-risk individuals. Trial Registration: Clinical Trials Registry of India Identifier: CTRI/2017/06/008744; Sri Lanka Clinical Trials Registry Identifier: SLCTR/2017/001; and ClinicalTrials.gov Identifier: NCT03305939.
Subject(s)
Diabetes Mellitus, Type 2/prevention & control , Diabetes, Gestational/prevention & control , Diet , Exercise , Glycemic Control/methods , Life Style , Postpartum Period , Adult , Bangladesh , Blood Glucose , Diabetes Mellitus, Type 2/ethnology , Diabetes, Gestational/ethnology , Female , Glucose Tolerance Test , Humans , India , Pregnancy , Sri Lanka , Survival Analysis , Treatment Outcome , Urban PopulationABSTRACT
We describe the experiences of research personnel in collecting road safety data, using a range of quantitative and qualitative methods to collect primary and secondary data, in the course of monitoring and evaluating the impact of road safety interventions under the Bloomberg Philanthropies Global Road Safety Program, in Hyderabad, India. We detail environmental, administrative, and operational barriers encountered, and individual, systemic, and technical enablers pertaining to the conduct of road safety research in Hyderabad, India, but bearing relevance to broader public health research and practice and the implementation and evaluation of projects. From our experiences of the challenges and the solutions developed to address them, we set out recommendations for research teams and for administrators in road safety as well as in various other streams of public health research and practice. We propose actionable strategies to enhance data-collectors' safety; build effective partnerships with various stakeholders, including research collaborators, administrators, and communities; and strengthen data quality and streamlining systems, particularly in similar geo-political settings.
Subject(s)
Automobile Driving , Research Personnel , Accidents, Traffic/prevention & control , Humans , IndiaABSTRACT
This review examined the determinants, patterns and imports of official recognition, and incorporation of different traditional, complementary and alternative systems of medicine (TCAM) in the public health establishment of low- and middle-income countries, with a particular focus on India. Public health systems in most countries have tended to establish health facilities centred on allopathy, and then to recognize or derecognize different TCAM based on evidence or judgement, to arrive at health-care configurations that include several systems of medicine with disparate levels of authority, jurisdiction and government support. The rationale for the inclusion of TCAM providers in the public health workforce ranges from the need for personnel to address the disease burden borne by the public health system, to the desirability of providing patients with a choice of therapeutic modalities, and the nurturing of local culture. Integration, mostly described as a juxtaposition of different systems of medical practice, is often implemented as a system of establishing personnel with certification in different medical systems, in predominantly allopathic health-care facilities, to practise allopathic medicine. A hierarchy of systems of medicine, often unacknowledged, is exercised in most societies, with allopathy at the top, certain TCAM systems next and local healing traditions last. The tools employed by TCAM practitioners in diagnosis, research, pharmacy, marketing and education and training, which are seen to increasingly emulate those of allopathy, are sometimes inappropriate for use in therapeutic systems with widely divergent epistemologies, which call for distinct research paradigms. The coexistence of numerous systems of medicine, while offering the population greater choice, and presumably enhancing geographical access to health care as well, is often fraught with tensions related to the coexistence of philosophically disparate, even opposed, disciplines, with distinct and unaligned notions of evidence and efficacy, and ethical and operational challenges of the administration of a plural workforce.