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1.
BMC Public Health ; 24(1): 1361, 2024 May 20.
Artigo em Inglês | MEDLINE | ID: mdl-38769491

RESUMO

Smokeless tobacco (SLT) poses many negative health impacts. Despite its longstanding presence in societies across the world, the health implications of SLT have only been rigorously studied in recent decades. This systematic review and meta-analysis aimed to consolidate existing research to provide a comprehensive understanding of the global prevalence of SLT use among women of reproductive age. Relevant articles were extracted from databases such as PubMed, EMBASE, Web of Science, and Scopus from their inception until November 11, 2023. Observational studies reporting the number of SLT users among women of reproductive age were included. The quality of the studies was assessed using the Joanna Briggs Institute (JBI) tool. The meta-analysis used a random-effects model to determine SLT prevalence, supported by statistical tools like forest plots, I2 statistics, and sensitivity analyses to ensure the accuracy and comprehensiveness of the results. All statistical analyses were performed in R version 4.3. From 10 studies involving 2,053,667 participants, a pooled prevalence for SLT use among women of reproductive age was found to be 9.3% (95% CI: 0.038 to 0.21), with significant heterogeneity among studies (I2 = 100%). Publication bias was suspected among the studies. Sensitivity analysis and subgroup analysis couldn't resolve the heterogeneity. Our analysis shows a significant prevalence of SLT use in women of reproductive age, especially in low socioeconomic and developing countries like India, Pakistan, and Nepal. For women of reproductive age, the use of smokeless tobacco (SLT) can lead to infertility, pregnancy complications, and adverse fetal outcomes, including low birth weight and preterm birth. The results highlight the necessity for specific public health measures and policy changes to decrease SLT consumption among reproductive-age women. Further studies are needed to investigate the reasons behind SLT usage in this group and to assess the impact of intervention strategies, to guide more effective public health initiatives and policies.


Assuntos
Uso de Tabaco , Tabaco sem Fumaça , Humanos , Tabaco sem Fumaça/estatística & dados numéricos , Feminino , Uso de Tabaco/epidemiologia , Prevalência , Adulto , Gravidez
2.
Curr Probl Cardiol ; 49(7): 102605, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38692448

RESUMO

BACKGROUND: While Cardiovascular disease (CVD) affects both men and women, emerging evidence suggests notable gender differentials in disease prevalence. This study aims to explore and analyse the gender differentials in CVD disease prevalence in India. METHODS: The present study utilizes data from first wave of the nationally representative survey "Longitudinal Ageing Study in India" (LASI, WAVE-I, 2017-18) with the eligible sample size of 31,464 individuals aged 60 years and above. Logistic regression analysis was used to understand risk of CVD by demographic characteristics. Factors contribution to gender differences in CVD prevalence was examined using a non-linear Fairlie decomposition. RESULTS: The prevalence of CVD was lower in men (31.06%) compared to women (38.85%). Women have a 33% higher likelihood of CVD compared to men (OR: 1.33; 95% CI: 1.25-1.42). Lack of education also confers a lower risk, more pronounced in women with no schooling (OR: 0.81; 95% CI: 0.7-0.94) compared to men (OR: 0.52; 95% CI: 0.47-0.58). Morbidity influences CVD presence more among women than men, with individuals suffering from three or more diseases having markedly increased odds (Men: OR: 3.89; 95% CI: 3.54-4.3, Women: OR: 6.97; 95% CI: 6.48-10.11). Smoking accounted increase in (20.52%) the gender gap while years of schooling dramatically lessened the gender gap (-46.30%). CONCLUSION: Result show gender differential in CVD prevalence and underlying risk factors, underscoring the need for gender-specific preventive strategies and interventions. Our findings highlight the importance of refined approach to cardiovascular health that considers the complex interplay of biological, social, and environmental determinants.


Assuntos
Doenças Cardiovasculares , Humanos , Masculino , Feminino , Doenças Cardiovasculares/epidemiologia , Índia/epidemiologia , Idoso , Prevalência , Pessoa de Meia-Idade , Fatores Sexuais , Fatores de Risco , Estudos Longitudinais , Disparidades nos Níveis de Saúde , Distribuição por Sexo , Fatores Socioeconômicos , Idoso de 80 Anos ou mais
3.
Curr Probl Cardiol ; : 102632, 2024 May 24.
Artigo em Inglês | MEDLINE | ID: mdl-38797508

RESUMO

BACKGROUND: Post-traumatic stress disorder (PTSD) is increasingly recognized for its effects beyond mental health, with emerging evidence suggesting a significant association with cardiovascular diseases (CVD). This systematic review and meta-analysis aimed to synthesize available evidence on the association between PTSD and various cardiovascular outcomes. METHODS: We conducted a comprehensive literature search in databases until March 15, 2024. Studies were included if they were observational in design and assessed the association between PTSD and cardiovascular outcomes. Data were extracted on study characteristics, participant demographics, PTSD assessment, cardiovascular outcomes, and effect estimates. Meta-analyses were performed using random-effects models, and heterogeneity was assessed using the I² statistic. All statistical analyses were conducted using R software version 4.3. RESULTS: Twenty studies met the inclusion criteria, encompassing a total of over 335,000 participants. The pooled analyses demonstrated a statistically significant increased risk of any CVD (HR = 1.417, 95% CI: 1.313-1.522), MI (HR = 1.415, 95% CI: 1.331-1.500), and stroke (HR = 2.074, 95% CI: 1.165-2.982) associated with PTSD. Substantial heterogeneity was observed across the studies for stroke and MACE, and evidence of publication bias was noted. CONCLUSION: This meta-analysis confirms a significant association between PTSD and an increased risk of several cardiovascular outcomes, indicating the importance of integrating cardiovascular risk management with psychiatric care for PTSD patients to mitigate the heightened risk of CVDs. Future research should focus on exploring the underlying mechanisms and potential interventions to manage both PTSD and its associated cardiovascular risks effectively.

4.
Cureus ; 16(4): e58167, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38741824

RESUMO

Lymphatic filariasis, caused by filarial worms such as Wuchereria bancrofti, Brugia malayi, and Brugia timori, represents a significant public health burden in endemic regions. The disease primarily affects the lymphatic system, leading to lymphatic dysfunction and chronic morbidity. This abstract provides a comprehensive overview of lymphatic filariasis, including its transmission dynamics, pathogenesis, clinical manifestations, diagnostic approaches, and treatment options. Special attention is given to the socioeconomic impact of the disease and the challenges associated with its control and elimination. The patient in this particular case is a 58-year-old man who had lower limb swelling and pain, characteristic of chronic lymphatic obstruction. Additionally, the swelling tends to worsen during the evening hours often resulting in difficulty in walking and discomfort. Lymphatic filariasis was diagnosed based on clinical presentation.

6.
Cureus ; 16(4): e58621, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38770475

RESUMO

This review provides a comprehensive analysis of the public health strategies employed during the Zika outbreak in India, focusing on the identification, surveillance, and containment efforts. The multifaceted approach, including vector control measures, healthcare infrastructure enhancement, and public communication strategies, played a pivotal role in mitigating the impact of the virus. Government policies and international collaborations emerged as influential factors, underscoring the significance of a coordinated response to infectious disease crises. The study emphasizes the importance of ongoing vigilance and preparedness in public health systems, acknowledging the dynamic nature of emerging infectious diseases. The Zika outbreak in India serves as a valuable case study, offering insights into the strengths and weaknesses of crisis management responses. As the global community faces ongoing health challenges, the lessons learned from this review contribute to refining strategies, improving coordination, and fostering a proactive and resilient approach to safeguarding public health.

7.
Int J Surg ; 2024 May 22.
Artigo em Inglês | MEDLINE | ID: mdl-38775499

RESUMO

BACKGROUND: Stem cell therapy offers promising benefits like modulating immune responses, reducing inflammation, and aiding liver regeneration. This umbrella review seeks to compile evidence from systematic reviews to assess the efficacy of stem cell therapy for improving liver function and survival rates in chronic liver disease patients. METHODS: We searched electronic databases up to February 15, 2024. The selection process focused on systematic reviews comparing stem cell therapy with standard care or a placebo. The primary outcomes evaluated were changes in liver enzymes, the MELD score, and survival rates. Nested Knowledge software was utilized for screening and data extraction. All statistical analyses were performed using R software, version 4.3. RESULTS: Our umbrella review included 28 systematic reviews. The meta-analysis showcased a notable improvement in survival rates with a pooled RR of 1.487 (95% CI: 1.281 to 1.727). In non-randomized studies, albumin levels exhibited an SMD of 0.786 (95% CI: 0.368 to 1.204), indicating positive therapeutic effects. For ALT, the meta-analysis revealed a decrease in levels with an SMD of -0.499 (95% CI: -0.834 to -0.164), and for AST, an overall SMD of -0.362 (95% CI: -0.659 to -0.066) was observed, suggesting hepatoprotective effects. No significant changes were observed in total bilirubin levels and MELD scores in RCTs. CONCLUSION: Stem cell therapy exhibits potential as a novel treatment for chronic liver diseases, as it has demonstrated improvements in survival rates and certain liver function markers. More high-quality RCTs are needed in the future to fully ascertain the efficacy of stem cell therapy in this patient population.

8.
Artigo em Inglês | MEDLINE | ID: mdl-38708708

RESUMO

The World Health Organization's (WHO) designation of noma as a neglected tropical disease (NTD) on 15 December 2023 marks a crucial advancement in global health efforts. This move sheds light on a condition predominantly affecting undernourished children in isolated regions of sub-Saharan Africa. Recognized as the 21st NTD, noma, or cancrum oris, is a serious condition leading to orofacial gangrene. The disease largely impacts young children and those with compromised immune systems, including individuals with human immunodeficiency virus or leukaemia. Determining the exact prevalence of noma is complex, hindered by rapid disease progression, societal stigma and a lack of reporting, especially in impoverished areas. The WHO's acknowledgment is a significant step, emphasizing the need for more in-depth research and resources to address this overlooked disease. It highlights the critical role of multifaceted prevention strategies, including economic empowerment, improved nutrition and enhanced vaccination efforts. This recognition is pivotal in guiding international health initiatives towards better outcomes for some of the most at-risk populations globally.

9.
Ophthalmol Ther ; 13(6): 1635-1645, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38627321

RESUMO

INTRODUCTION: The COVID-19 pandemic has initiated an unparalleled global vaccination campaign, raising concerns about the vaccine's effects on various health conditions, including the risk of corneal transplant rejection. This systematic review aimed to identify the relationship between COVID-19 vaccination and rejection of corneal transplant, filling a significant gap in the existing medical literature. METHODS: A literature search was performed across multiple databases up to February 12, 2024, to identify studies evaluating the risk of corneal transplant rejection post-COVID-19 vaccination. Eligible studies were original research that reported outcomes of corneal graft rejection following vaccination. Nested Knowledge web software facilitated screening and data extraction. The Newcastle-Ottawa Scale was employed for quality assessment. A meta-analysis was conducted to calculate the aggregated relative risk (RR) utilizing R software version 4.3. RESULTS: Six studies were included in the qualitative synthesis, with four meeting the criteria for meta-analysis. These studies varied in geographic location, surgical techniques, and types of vaccines used. The pooled RR for corneal transplant rejection following COVID-19 vaccination was 0.816 (95% CI 0.178-1.453), indicating no significant risk of rejection. No statistical heterogeneity was observed among the studies (I2 = 0%). CONCLUSIONS: This review and meta-analysis found no significant evidence that COVID-19 vaccination increases the risk of corneal graft rejection. However, the current evidence is insufficient to conclusively determine the vaccine's safety for corneal transplant recipients. These findings underscore the need for additional research to confirm these preliminary results and investigate the long-term effects of COVID-19 vaccination on corneal transplants, aiming to provide evidence-based guidance to healthcare providers and patients.

10.
Cureus ; 16(3): e57027, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38681366

RESUMO

This review explores the trends and patterns of non-communicable disease (NCD) risk factors in India, with a focus on tobacco use, unhealthy diet, physical inactivity, and air pollution. Drawing upon existing literature and data, the review highlights the substantial burden imposed by NCDs and their associated risk factors on public health and healthcare systems in India. Key findings reveal the widespread prevalence of these risk factors, particularly among certain demographic groups and in urban areas. Socioeconomic disparities also play a significant role in shaping the distribution of NCD risk factors across the population. The review underscores the importance of addressing NCD risk factors through evidence-based interventions and policies tailored to the Indian context. Furthermore, it emphasizes the need for multi-sectoral collaboration among government agencies, healthcare providers, civil society organizations, academia, industry partners, and communities to mitigate the NCD epidemic effectively. By mobilizing collective efforts and resources, India can make significant strides in preventing and controlling NCDs, thereby enhancing population health and well-being.

11.
Neurotoxicology ; 102: 106-113, 2024 Apr 17.
Artigo em Inglês | MEDLINE | ID: mdl-38636605

RESUMO

BACKGROUND: Obstructive Sleep Apnea (OSA) is a significant health concern characterized by recurrent upper airway blockages during sleep, causing various health issues. There's growing evidence of a link between air pollution and OSA, though research results have been inconsistent. This systematic review and meta-analysis aims to consolidate and examine data on the relationship between air pollution and OSA's risk and severity. METHODS: A literature search across PubMed, EMBASE, and Web of Science was conducted until January 10, 2024. The selection criteria targeted studies involving OSA participants or those at risk, with quantitative air pollution assessments. The Nested Knowledge software facilitated screening and data extraction, while the Newcastle-Ottawa Scale was used for quality assessment. Meta-analyses, utilizing random-effects models, computed pooled odds ratios (ORs) for the OSA risk associated with PM2.5 and NO2 exposure, analyzed using R software version 4.3. RESULTS: The systematic review included twelve studies, four of which were analyzed in the meta-analysis. The meta-analysis revealed diverse results on the association of PM2.5 and NO2 with OSA risk. PM2.5 exposure showed a pooled OR of 0.987 (95 % CI: 0.836-1.138), indicating no substantial overall impact on OSA risk. Conversely, NO2 exposure was linked to a pooled OR of 1.095 (95 % CI: 0.920-1.270), a non-significant increase in risk. Many studies found a relationship between air pollution exposure and elevated Apnea-Hypopnea Index (AHI) levels, indicating a relationship between air pollution and OSA severity. CONCLUSION: The findings suggest air pollutants, especially NO2, might play a role in worsening OSA risk and severity, but the evidence isn't definitive. This highlights the variability of different pollutants' effects and the necessity for more research. Understanding these links is vital for shaping public health policies and clinical approaches to address OSA amidst high air pollution.

12.
Indian J Community Med ; 49(1): 157-164, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38425985

RESUMO

Background: Soil-transmitted helminth (STH) infections are widespread in developing countries with inadequate sanitation facilities. These infections can lead to malnutrition, anemia, and other complications that can negatively impact both the mother's and fetus's health during pregnancy. This study aimed to estimate the burden of STH by Kato-Katz microscopy and quantitative polymerase chain reaction (qPCR) in pregnant women from rural India. The diagnostic accuracy of these two methods was also compared. Material and Methods: A community-based cross-sectional study was conducted in rural areas of Wardha district of Maharashtra state. We randomly selected and interviewed 688 pregnant women. A total of 534 (77.61%) participants gave stool samples. Two containers (60 mL) labeled with a unique identification number were given to pregnant women to collect stool samples for Kato-Katz microscopy and qPCR. Stool specimens were transported to an accredited lab and examined within 24 hours. Suitable examinations were conducted to compare sensitivity between two tests. Results: The results are presented for 534 participants who gave stool samples. The prevalence of any STH by Kato-Katz stool microscopy was 6.55% (95%CI 4.46-12.19), and that by qPCR was 20.41 (95%CI 17.53-29.40). The sensitivity of Kato-Katz microscopy was 29.17% compared to sensitivity of 90.83% by qPCR (P = 0.001). Pregnant women with STH infection have a significantly lower weight gain during pregnancy, and the majority were either mild or moderate anemic compared to those without STH. Conclusion: The study highlighted significant differences in prevalence of STH among pregnant women by Kato-Katz microscopy and qPCR. The sensitivity of qPCR for detecting STH was higher than that of Kato-Katz microscopy.

13.
Egypt Heart J ; 76(1): 29, 2024 Feb 27.
Artigo em Inglês | MEDLINE | ID: mdl-38409614

RESUMO

BACKGROUND: The association of homocysteine with coronary artery disease (CAD) has been explored previously with mixed findings. The present Systematic Review and Meta-Analysis (SRMA) has assessed the pooled estimate of association between homocysteine (Hcy) and CAD, and its variation over the period and geography. METHODS: Systematic literature search was done in PubMed, Scopus and Cochrane to identify the observational studies that have reported mean Hcy among cases (CAD) and control. The SRMA was registered in PROSPERO (ID-CRD42023387675). RESULTS: Pooled standardized mean difference (SMD) of Hcy levels between the cases and controls was 0.73 (95% CI 0.55-0.91) from 59 studies. Heterogeneity was high (I2 94%). The highest SMD was found among the Asian studies (0.85 [95% CI 0.60-1.10]), while the European studies reported the lowest SMD between the cases and controls (0.32 [95% CI 0.18-0.46]). Meta-regression revealed that the strength of association was increasing over the years (Beta = 0.0227, p = 0.048). CONCLUSIONS: Higher homocysteine levels might have a significant association with coronary artery diseases, but the certainty of evidence was rated low, owing to the observational nature of the studies, high heterogeneity, and publication bias. Within the population groups, Asian and African populations showed a greater strength of association than their European and American counterparts, and it also increased over the years.

14.
Front Med (Lausanne) ; 11: 1340158, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38405188

RESUMO

Introduction: Anemia remains a prevalent global health issue with varying severity. Intravenous iron supplementation, particularly with ferric carboxymaltose (FCM), has appeared as a possible therapeutic intervention for individuals with moderate to severe anemia. The study aimed to assess the efficacy and safety of ferric carboxymaltose (FCM) in reducing anemia. Methods: We searched electronic databases, registries, websites, e-libraries, reference lists of reviews, citations, etc. We included randomized control trials (RCTs), non-RCTs, and single-arm studies, while observational studies, case series, and case studies were excluded. Two reviewers independently screened the studies and extracted the data. We included studies of moderate-to-severely anemic Indians and excluded Indians with other comorbidities. We assessed the risk of bias and the overall quality of evidence (QoE) using GRADE GDT. Result: We identified 255 studies and included 14 studies (11 RCT, one non-RCT, and two single-arm studies) with 1,972 participants for qualitative analysis and 10 studies in the meta-analysis. All the included studies detailed the use of FCM for anemia. The primary outcomes assessed in the included studies were anemia, hemoglobin, and adverse events. The outcomes assessed ranged from 2 weeks to 12 weeks. The risk of bias varied across different studies with different outcomes. FCM is consistent with a fewer number of adverse events as compared to other interventions and provides "moderate" to "very low" QoE. Conclusion: A slow single infusion of 1 gram of FCM is well-tolerated, safe, and effective in treating iron deficiency anemia (IDA) and surpasses other interventions (Iron Sucrose Complex (ISC), Iron sucrose, and ferrous ascorbate) in elevating hemoglobin levels and replenishing iron stores. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=459363, CRD42023459363.

15.
Int J Surg ; 2024 Feb 06.
Artigo em Inglês | MEDLINE | ID: mdl-38320100

RESUMO

BACKGROUND: Stem cell therapy (SCT) has emerged as a potential therapeutic avenue, with various cell types being explored for their efficacy in treating DCM. However, the safety and efficacy of these therapies have been the subject of numerous systematic reviews. This umbrella review aims to consolidate the existing evidence on stem cell interventions for DCM, providing a comprehensive overview of the current research landscape. METHODS: This review was conducted following the JBI and PRISMA guidelines. Systematic reviews and meta-analyses of randomized controlled trials (RCTs) evaluating the safety and efficacy of SCT for DCM were included. Outcomes such as 6MWT, LVEDD, LVEF, MACE, NYHA, and QoL, among others, were considered. A literature search was executed across databases like PubMed, Embase, Web of Science, and Cochrane Database up to October 07, 2023. The quality of the included reviews was assessed using the JBI Checklist for Systematic Reviews and Research Syntheses. Data synthesis was carried out in both narrative and tabular formats, with the GRADE criteria guiding the determination of evidence certainty. RESULTS: Nine systematic reviews met the inclusion criteria. LVEF found to be significantly improved with SCT. LVEDD and LVEDV assessments yielded mixed results, with some reviews observing significant changes. LVESV showed consistent reductions across multiple studies. BNP concentrations post-interventions were explored in several studies, with mixed findings. Health-related quality of life (HRQL) showed varied results, with some studies noting improvements and others finding no significant differences. NYHA classifications and 6-MWT results indicated potential benefits from stem cell treatments. SCT was observed to be generally safe. The certainty of evidence was low or very low for most of outcomes. CONCLUSION: SCT showed has shown promise in treating DCM, with many studies highlighting its safety and potential benefits. Nonetheless, the existing data has its limitations due to biases in the RCTs studies. To truly establish the benefits of SCT for DCM, future high quality RCTS, are crucial.

16.
Curr Probl Cardiol ; 49(4): 102438, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38301916

RESUMO

BACKGROUND: Hypertension impacts nearly one billion individuals and is a primary health challenge. While traditional perspectives have focused on individual behavior and genetics as principal risk factors, recent research underscores the profound influence of socioeconomic factors within neighborhoods on the risk of hypertension. This systematic review and meta-analysis is aimed to elucidate the association between neighborhood deprivation and the risk of hypertension. METHODS: A comprehensive literature search was conducted across PubMed, Embase, and Web of Science from inception until December 25, 2023. Observational studies defining neighborhood deprivation and reporting hypertension incidence were included. Nested Knowledge software was used for screening and data extraction, with study quality assessed using the Newcastle-Ottawa Scale. Statistical analysis was performed with R software (V 4.3), using a random-effects model to calculate the pooled relative risk (RR). RESULTS: Twenty-six studies were included in the qualitative analysis and 22 in the meta-analysis, covering over 62 million participants. The pooled RR was 1.139 (95% CI: 1.006 - 1.290), p=0.04, indicating a higher hypertension risk in deprived neighborhoods. Subgroup analyses showed variability by country and deprivation assessment methods. RR varied from 1.00 in Japan (95% CI: 0.93-1.08) to 1.60 (95% CI: 1.07-2.39) in France and 1.57 (95% CI: 0.67-3.70) in Germany, with significant heterogeneity observed in measures of neighborhood deprivation. CONCLUSION: Our analysis confirms a significant association between neighborhood deprivation and hypertension, underscoring the importance of socioeconomic factors in public health. It highlights the need for targeted local assessments and interventions. Future research should explore the causal mechanisms and effectiveness of interventions addressing neighborhood deprivation.


Assuntos
Hipertensão , Humanos , Hipertensão/epidemiologia , Hipertensão/etiologia , Saúde Pública , Fatores de Risco , Fatores Socioeconômicos
19.
Cureus ; 15(11): e48406, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-38074002

RESUMO

Torsion of the ovarian cyst is a gynecological emergency that can arise during pregnancy. Regardless of gestational age, surgical procedures should be explored in the course of the growth of adnexal torsion. Although ovarian torsion is not as common during pregnancy and may be an incidental finding, it is always better to stay cautious. If neglected, they may be deemed hazardous to both the baby and the mother. Here we are reporting a case of a 25-year-old multigravida woman who is in the first trimester of her pregnancy, and presented with the complaint of acute abdominal pain for 3 days. On ultrasound, torsion of the right ovarian cyst was found. She underwent laparoscopy and a right-sided salpingo-oophorectomy was done. The biopsy report revealed a benign hemorrhagic cyst. She has been under observation and is asymptomatic, with clear imaging and laboratory values.

20.
Front Public Health ; 11: 1165728, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-38035279

RESUMO

Background: To promote early childhood development (ECD), we require information not only on what needs to be addressed and on what effects can be achieved but also on effective delivery methods that can be adapted to local context. We describe design, implementation, and evaluation of a complex intervention to strengthen nurturing environment for young children. Methods: Study participants were pregnant women and their children from birth to 2 years. We used design and redesign, implementation, and evaluation approaches for the study. We co-created curriculum and delivery plan with stakeholders, based on the theoretical framework, findings from formative research, and our preliminary work. We recruited 656 pregnant women and newborns, 326 (49.69%) from intervention and 330 (50.30%) from the control group. We conducted a cluster randomized controlled trial to evaluate the program's effectiveness. The outcomes of children were assessed at 12 and 24 months. Findings: At recruitment, study participants from both the study arms were similar in sociodemographic characteristics. We conducted 6,665 home visits, 25 toy-making workshops, and 65 caregiver-meetings. The initial examination of program data revealed gaps in quality and coverage of interventions. The intervention was redesigned based on feedback from stakeholders in community meetings. At recruitment, participants in both study groups had similar socio-demographics. We conducted 6,665 home visits, 25 toy workshops, and 65 caregiver meetings. Initial program data showed intervention quality and coverage gaps, leading to a redesign program based on community and stakeholder feedback. Post-re-designing, session quality improved, with program coverage rising from 32 to 98%. Male participation in home visits increased from 4.3 to 32.65%, and data errors reduced from 270 to 140 per month on average. At 24 months, program showed moderate-mild impact on ECD - cognitive (0.31, 95%CI: 0.13-0.48), language (0.2, 95%CI: 0.01-0.39), and socioemotional-development (0.19, 95%CI: 0.01-0.37), moderate effect on home-environment and mother-child interaction. 96% of women initiated breastfeed within one-hour of delivery, and exclusive-breastfeeding rate of 89.80%. Interpretations: The study provides an evidence-based community centered ECD curriculum and implementation strategies to enhance service providers, and caregivers' knowledge and skills for promoting ECD in low-resource settings with the potential to scale within existing Government Program. Funding: The trial was funded by the Saving Brains Round 5 Initiative of Grand Challenges Canada (Grant no. SB-1707-05084), and we are grateful for their ongoing support through online sessions and orientation workshops. The trial was also supported by the Indian Council of Medical Research (File No: 5/7/1693/CH/Adhoc/RBMCH-2020).


Assuntos
Desenvolvimento Infantil , Poder Familiar , Pré-Escolar , Feminino , Humanos , Recém-Nascido , Masculino , Gravidez , Aleitamento Materno , Índia , Gestantes , Lactente
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