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Background Despite harmful drinking causing a significant burden on global health, there is a large treatment gap, especially in low- and middle-income countries. A major barrier to care is the lack of adequately skilled human resources to deliver contextually appropriate treatments. This paper describes the systematic process used to develop Counselling for Alcohol Problems ( CAP), a brief psychological treatment (PT) for delivery by lay counselors in routine primary care settings to men with harmful drinking in India. Methods CAP was developed using a methodology involving 3 sequential steps: (i) identifying potential treatment strategies; (ii) developing a theoretical framework for the treatment; and (iii) evaluating the acceptability and feasibility of the treatment. Results CAP is a 3-phase treatment delivered over 1 to 4 sessions based on a motivational interviewing ( MI) stance and involves the following strategies: assessment and personalized feedback, family engagement, drink refusal skills, skills to address drinking urges, problem-solving skills and handling difficult emotions, and relapse prevention and management. Data from a case series were used to inform several adaptations to enhance the acceptability of CAP to the recipients and feasibility of delivery by lay counselors of the treatment, for example expansion of the target group to include alcohol-dependent patients and the extension of the delivery settings to include home-based delivery. There was preliminary evidence of the effectiveness of CAP. Conclusions CAP is an acceptable brief PT for harmful drinking delivered by lay counselors in primary care whose effectiveness is currently being tested in a randomized controlled trial based in primary care in Goa, India. [ABSTRACT FROM AUTHOR]

Folate and vitamin B12 are essential for growth. Our objective was to estimate their long-term effects on linear growth in North Indian children. This is a follow-up study of a factorial designed, double-blind, randomised, placebo-controlled trial in 1000 young children. Starting at 6–30 months of age, we gave folic acid (approximately 2 RDA), vitamin B12 (approximately 2 RDA), both vitamins or a placebo daily for 6 months. Six years after the end of supplementation, we measured height in 791 children. We used the plasma concentrations of cobalamin, folate and total homocysteine to estimate vitamin status. The effect of the interventions, the association between height-for-age z-scores (HAZ) and baseline vitamin status, and the interactions between supplementation and baseline status were estimated in multiple regression models. Mean (sd) age at follow-up was 7·4 (0·7) years (range 6 to 9 years). There was a small, non-significant effect of vitamin B12 on linear growth and no effect of folic acid. We observed a subgroup effect of vitamin B12 supplementation in those with plasma cobalamin concentration < 200 pmol/l (P for interaction = 0·01). The effect of vitamin B12 supplementation in this group was 0·34 HAZ (95 % CI 0·11, 0·58). We found an association between cobalamin status and HAZ in children not given vitamin B12 (P for interaction = 0·001). In this group, each doubling of the cobalamin concentration was associated with 0·26 (95 % CI 0·15, 0·38) higher HAZ. Suboptimal vitamin B12 status in early childhood seemingly limits linear growth in North Indian children. [ABSTRACT FROM AUTHOR]

Maternal iodine (I) status is critical in embryonic and foetal development. We examined the effect of preconception iodine supplementation on maternal iodine status and on birth outcomes. Non‐pregnant women in Guatemala, India and Pakistan (n ~ 100 per arm per site) were randomized ≥ 3 months prior to conception to one of three intervention arms: a multimicronutrient‐fortified lipid‐based nutrient supplement containing 250‐μg I per day started immediately after randomization (Arm 1), the same supplement started at ~12 weeks gestation (Arm 2) and no intervention supplement (Arm 3). Urinary I (μg/L) to creatinine (mg/dl) ratios (I/Cr) were determined at 12 weeks for Arm 1 versus Arm 2 (before supplement started) and 34 weeks for all arms. Generalized linear models were used to assess the relationship of I/Cr with arm and with newborn anthropometry. At 12 weeks gestation, adjusted mean I/Cr (μg/g) for all sites combined was significantly higher for Arm 1 versus Arm 2: (203 [95% CI: 189, 217] vs. 163 [95% CI: 152, 175], p < 0.0001). Overall adjusted prevalence of I/Cr < 150 μg/g was also lower in Arm 1 versus Arm 2: 32% (95% CI: 26%, 38%) versus 43% (95% CI: 37%, 49%) (p = 0.0052). At 34 weeks, adjusted mean I/Cr for Arm 1 (235, 95% CI: 220, 252) and Arm 2 (254, 95% CI: 238, 272) did not differ significantly but were significantly higher than Arm 3 (200, 95% CI: 184, 218) (p < 0.0001). Nominally significant positive associations were observed between I/Cr at 12 weeks and birth length and head circumference z‐scores (p = 0.028 and p = 0.005, respectively). These findings support the importance of first trimester iodine status and suggest need for preconception supplementation beyond salt iodization alone. [ABSTRACT FROM AUTHOR]

Objectives mHealth interventions for MNCH have been shown to improve uptake of antenatal and neonatal services in low- and middle-income countries (LMICs). However, little systematic analysis is available about their impact on infant health outcomes, such as reducing low birth weight or malnutrition among children under the age of five. The objective of this study is to determine if an age- and stage-based mobile phone voice messaging initiative for women, during pregnancy and up to 1 year after delivery, can reduce low birth weight and child malnutrition and improve women's infant care knowledge and practices. Methods We conducted a pseudo-randomized controlled trial among pregnant women from urban slums and low-income areas in Mumbai, India. Pregnant women, 18 years and older, speaking Hindi or Marathi were enrolled and assigned to receive mMitra messages (intervention group N = 1516) or not (Control group N = 500). Women in the intervention group received mMitra voice messages two times per week throughout their pregnancy and until their infant turned 1 year of age. Infant's birth weight, anthropometric data at 1 year of age, and status of immunization were obtained from Maternal Child Health (MCH) cards to assess impact on primary infant health outcomes. Women's infant health care practices and knowledge were assessed through interviews administered immediately after women enrolled in the study (Time 1), after they delivered their babies (Time 2), and after their babies turned 1 year old (Time 3). 15 infant care practices self-reported by women (Time 3) and knowledge on ten infant care topics (Time 2) were also compared between intervention and control arms. Results We observed a trend for increased odds of a baby being born at or above the ideal birth weight of 2.5 kg in the intervention group compared to controls (odds ratio (OR) 1.334, 95% confidence interval (CI) 0.983–1.839, p = 0.064). The intervention group performed significantly better on two infant care practice indicators: giving the infant supplementary feeding at 6 months of age (OR 1.4, 95% CI 1.08–1.82, p = 0.009) and fully immunizing the infant as prescribed under the Government of India's child immunization program (OR 1.531, 95% CI 1.141–2.055, p = 0.005). Women in the intervention group had increased odds of knowing that the baby should be given solid food by 6 months (OR 1.89, 95% CI 1.371–2.605, p < 0.01), that the baby needs to be given vaccines (OR 1.567, 95% CI 1.047–2.345, p = 0.028), and that the ideal birth weight is > 2.5 kg (OR 2.279, 95% CI 1.617–3.213, p < 0.01). Conclusions for Practice This study provides robust evidence that tailored mobile voice messages can significantly improve infant care practices and maternal knowledge that can positively impact infant child health. Furthermore, this is the first prospective study of a voice-based mHealth intervention to demonstrate a positive impact on infant birth weight, a health outcome of public health importance in many LMICs. [ABSTRACT FROM AUTHOR]

Objectives To examine the effects of oral maternal vitamin B12 supplementation during pregnancy and early lactation on cognitive development in children. Method We studied 218 children born to mothers enrolled in a placebo-controlled, randomized trial of vitamin B12 supplementation during pregnancy through 6 weeks post-partum. Cognitive functions were assessed at 30 months using the Bayley Scales of Infant Development- 3rd edition (BSID III). The association of maternal sociodemographic characteristics, maternal biochemical status during pregnancy, birth weight and home environment with each sub-domain of BSID-III was examined using linear regression analysis. Separate multiple linear regression analyses for each of the BSID-III sub-domains with maternal trimester specific nutritional biomarker status was conducted. Results Children of mothers who received oral vitamin B12 supplementation had significantly higher scores on expressive language compared to children of mothers who received placebo (β = 0.14, P = 0.03). Children of mothers with elevated serum total homocysteine (tHcy) in the second and third trimesters of pregnancy had significantly lower scores on expressive language (β = − 0.18, P = 0.03 and β = − 0.19, P = 0.02, respectively) and gross motor domains (β = − 0.23, P = 0.008 and β = − 0.30, P = 0.001, respectively) of BSID-III adjusted for treatment arm and multiple confounders, compared with children whose mothers did not have elevated tHcy. Conclusions for practice Maternal B12 supplementation during pregnancy was associated with higher expressive language scores in children at 30 months. Elevated maternal tHcy levels during pregnancy had negative associations with expressive language and gross motor domains of BSID-III. Larger trials of maternal B12 supplementation are needed to confirm these findings. [ABSTRACT FROM AUTHOR]

To test the efficacy of an intervention to reduce tobacco use among youth (10-19 years old) in slum communities in Delhi, India. This community- based cluster-randomized trial included 14 slums composed of purposely built resettlement colonies and adjacent inhabitant-built Jhuggi Jhopris. Youth in the intervention received a 2 year multiple-component intervention: (a) youth and adult leader training; (b) peer-led interactive activities and outreach; (c) tobacco cessation camps; and (d) enforcement of India's Tobacco Control Law (smoke-free environments and youth access). Overall, no differences between the intervention and control conditions were observed over time; self-reported tobacco use declined in both groups. However, when stratified by type of residence, a significant decrease was observed among youth in the resettlement colonies in the intervention group for overall tobacco use (slope=-0.69) and cigarette and bidi smoking (slope=-0.66), compared to an increase in the control group (slope=0.24 and 0.12, respectively) (P<0.001). No differences in smokeless tobacco (SLT) use were observed for either group. Comprehensive community-based interventions that engage youth can be effective in reducing smoking among disadvantaged youth in India. More intensive interventions, like tax increases or large-scale media campaigns, appear warranted for the most marginalized in this context and for SLT products. [ABSTRACT FROM AUTHOR]

Background: Antenatal corticosteroids are commonly used to reduce neonatal mortality, but most research to date has been in high-resource settings and few studies have evaluated its impact on stillbirth. In the Antenatal Corticosteroids Trial (ACT), a multi-country trial to assess impact of a multi-faceted intervention including antenatal corticosteroids to reduce neonatal mortality associated with preterm birth, we found an overall increase in 28-day neonatal mortality and stillbirth associated with the intervention. Methods: The ACT was a cluster-randomized trial conducted in 102 clusters across 7 research sites in 6 countries (India [2 sites], Pakistan, Zambia, Kenya, Guatemala and Argentina), comparing an intervention to train birth attendants at all levels of the health system to identify women at risk of preterm birth, administer corticosteroids and refer women at risk. Because of inadequate gestational age dating, the <5th percentile birth weight was used as a proxy for preterm birth. A pre-specified secondary outcome of the trial was stillbirth. Results: After adjusting for the pre-trial imbalance in stillbirth rates, the ACT intervention was associated with a non-significant increased risk of stillbirth (aRR 1.08, 95 % CI, 0.99-1.17, p-0.073). Additionally, the stillbirth rate was higher in the term births (1.20 95 % CI 1.06-1.37, 0.004) and among those with signs of maceration (RR 1.18 (1.04-1.35), p = 0.013) in the intervention vs. control clusters. Differences in obstetric care favored the control clusters and maternal infection was likely more common in the intervention clusters. Conclusions: In this pragmatic trial, limited data were available to identify the causes of the increase in stillbirths in the intervention clusters. A higher rate of stillbirth in the intervention clusters prior to the trial, differences in obstetric care and an increase in maternal infection are potential explanations for the observed increase in stillbirths in the intervention clusters during the trial. Trial registration: clinicaltrials.gov (NCT01084096) [ABSTRACT FROM AUTHOR]

Background: The Antenatal Corticosteroid Trial (ACT) assessed the feasibility, effectiveness, and safety of a multifaceted intervention to increase the use of antenatal corticosteroids (ACS) in mothers at risk of preterm birth at all levels of care in low and middle-income countries. The intervention effectively increased the use of ACS but had no overall impact on neonatal mortality in the targeted <5th percentile birth weight infants. Being in the intervention clusters was also associated with an overall increase in neonatal deaths. We sought to explore plausible pathways through which this intervention increased neonatal mortality. Methods: We conducted secondary analyses to assess site differences in outcome and potential explanations for the differences in outcomes if found. By site, and in the intervention and control clusters, we evaluated characteristics of the mothers and care systems, the proportion of the <5th percentile infants and the overall population that received ACS, the rates of possible severe bacterial infection (pSBI), determined from clinical signs, and neonatal mortality rates. Results: There were substantial differences between the sites in both participant and health system characteristics, with Guatemala and Argentina generally having the highest levels of care. In some sites there were substantial differences in the health system characteristics between the intervention and control clusters. The increase in ACS in the intervention clusters was similar among the sites. While overall, there was no difference in neonatal mortality among <5th percentile births between the intervention and control clusters, Guatemala and Pakistan both had significant reductions in neonatal mortality in the <5th percentile infants in the intervention clusters. The improvement in neonatal mortality in the Guatemalan site in the <5th percentile infants was associated with a higher level of care at the site and an improvement in care in the intervention clusters. There was a significant increase overall in neonatal mortality in the intervention clusters compared to the control. Across sites, this increase in neonatal mortality was statistically significant and most apparent in the African sites. This increase in neonatal mortality was accompanied by a significant increase in pSBI in the African sites. Conclusions: The improvement in neonatal mortality in the Guatemalan site in the <5th percentile infants was associated with a higher level of care and an improvement in care in the intervention clusters. The increase in neonatal mortality in the intervention clusters across all sites was largely driven by the poorer outcomes in the African sites, which also had an increase in pSBI in the intervention clusters. We emphasize that these results come from secondary analyses. Additional prospective studies are needed to assess the effectiveness and safety of ACS on neonatal health in low resource settings. Trial registration: Trial registration: clinicaltrials.gov (NCT01084096) [ABSTRACT FROM AUTHOR]

This study involved evaluation of the short-term impact of the RHANI Wives HIV intervention among wives at risk for HIV from husbands in Mumbai, India. A two-armed cluster RCT was conducted with 220 women surveyed on marital sex at baseline and 4-5 month follow-up. RHANI Wives was a multisession intervention focused on safer sex, marital communication, gender inequities and violence; control participants received basic HIV prevention education. Generalized linear mixed models were conducted to assess program impact, with cluster as a random effect and with time, treatment group, and the time by treatment interaction as fixed effects. A significant time by treatment effect on proportion of unprotected sex with husband ( p = 0.01) was observed, and the rate of unprotected sex for intervention participants was lower than that of control participants at follow-up (RR = 0.83, 95 % CI = 0.75, 0.93). RHANI Wives is a promising model for women at risk for HIV from husbands. [ABSTRACT FROM AUTHOR]

Inadequate feeding and care may contribute to high rates of stunting and underweight among children in rural families in India. This cluster-randomized trial tested the hypothesis that teaching caregivers appropriate complementary feeding and strategies for how to feed and play responsively through home-visits would increase children's dietary intake, growth and development compared with home-visit-complementary feeding education alone or routine care. Sixty villages in Andhra Pradesh were randomized into three groups of 20 villages with 200 mother-infant dyads in each group. The control group (CG) received routine Integrated Child Development Services (ICDS); the complementary feeding group (CFG) received the ICDS plus the World Health Organization recommendations on breastfeeding and complementary foods; and the responsive complementary feeding and play group (RCF&PG) received the same intervention as the CFG plus skills for responsive feeding and psychosocial stimulation. Both intervention groups received bi-weekly visits by trained village women. The groups did not differ at 3 months on socioeconomic status, maternal and child nutritional indices, and maternal depression. After controlling for potential confounding factors using the mixed models approach, the 12-month intervention to the CFG and RCF&PG significantly ( P < 0.05) increased median intakes of energy, protein, Vitamin A, calcium (CFG), iron and zinc, reduced stunting [0.19, confidence interval (CI): 0.0-0.4] in the CFG (but not RCF&PG) and increased ( P < 0.01) Bayley Mental Development scores (mean = 3.1, CI: 0.8-5.3) in the RCF&PG (but not CFG) compared with CG. Community-based educational interventions can improve dietary intake, length (CFG) and mental development (RCF&PG) for children under 2 years in food-secure rural Indian families. [ABSTRACT FROM AUTHOR]