Intrahousehold power inequalities and cooperation: Unpacking household responses to nutrition-sensitive agriculture interventions in rural India.

Nutrition-sensitive agriculture (NSA) interventions offer a means to improve the dietary quality of rural, undernourished populations. Their effectiveness could be further increased by understanding how household dynamics enable or inhibit the uptake of NSA behaviours. We used a convergent parallel mixed-methods design to describe the links between household dynamics-specifically intrahousehold power inequalities and intrahousehold cooperation-and dietary quality and to explore whether household dynamics mediated or modified the effects of NSA interventions tested in a cluster-randomized trial, Upscaling Participatory Action and Videos for Agriculture and Nutrition (UPAVAN). We use quantitative data from cross-sectional surveys in 148 village clusters at UPAVAN's baseline and 32 months afterwards (endline), and qualitative data from family case studies and focus group discussions with intervention participants and facilitators. We found that households cooperated to grow and buy nutritious foods, and gendered power inequalities were associated with women's dietary quality, but cooperation and women's use of power was inhibited by several interlinked factors. UPAVAN interventions were more successful in more supportive, cooperative households, and in some cases, the interventions increased women's decision-making power. However, women's decisions to enter into negotiations with family members depended on whether women deemed the practices promoted by UPAVAN interventions to be feasible, as well as women's confidence and previous cultivation success. We conclude that interventions may be more effective if they can elicit cooperation from the whole household. This will require a move towards more family-centric intervention models that empower women while involving other family members and accounting for the varied ways that families cooperate and negotiate.

Economic Evaluation of Nutrition-Sensitive Agricultural Interventions to Increase Maternal and Child Dietary Diversity and Nutritional Status in Rural Odisha, India.

BACKGROUND: Economic evaluations of nutrition-sensitive agriculture (NSA) interventions are scarce, limiting assessment of their potential affordability and scalability. OBJECTIVES: We conducted cost-consequence analyses of 3 participatory video-based interventions of fortnightly women's group meetings using the following platforms: 1) NSA videos; 2) NSA and nutrition-specific videos; or 3) NSA videos with a nutrition-specific participatory learning and action (PLA) cycle. METHODS: Interventions were tested in a 32-mo, 4-arm cluster-randomized controlled trial, Upscaling Participatory Action and Videos for Agriculture and Nutrition (UPAVAN) in the Keonjhar district, Odisha, India. Impacts were evaluated in children aged 0-23 mo and their mothers. We estimated program costs using data collected prospectively from expenditure records of implementing and technical partners and societal costs using expenditure assessment data collected from households with a child aged 0-23 mo and key informant interviews. Costs were adjusted for inflation, discounted, and converted to 2019 US$. RESULTS: Total program costs of each intervention ranged from US$272,121 to US$386,907. Program costs per pregnant woman or mother of a child aged 0-23 mo were US$62 for NSA videos, US$84 for NSA and nutrition-specific videos, and US$78 for NSA videos with PLA (societal costs: US$125, US$143, and US$122, respectively). Substantial shares of total costs were attributable to development and delivery of the videos and PLA (52-69%) and quality assurance (25-41%). Relative to control, minimum dietary diversity was higher in the children who underwent the interventions incorporating nutrition-specific videos and PLA (adjusted RRs: 1.19 and 1.27; 95% CIs: 1.03-1.37 and 1.11, 1.46, respectively). Relative to control, minimum dietary diversity in mothers was higher in those who underwent NSA video (1.21 [1.01, 1.45]) and NSA with PLA (1.30 [1.10, 1.53]) interventions. CONCLUSION: NSA videos with PLA can increase both maternal and child dietary diversity and have the lowest cost per unit increase in diet diversity. Building on investments made in developing UPAVAN, cost-efficiency at scale could be increased with less intensive monitoring, reduced startup costs, and integration within existing government programs. This trial was registered at clinicaltrials.gov as ISRCTN65922679.

Understanding the effects of nutrition-sensitive agriculture interventions with participatory videos and women's group meetings on maternal and child nutrition in rural Odisha, India: A mixed-methods process evaluation.

A trial of three nutrition-sensitive agriculture interventions with participatory videos and women's group meetings in rural Odisha, India, found improvements in maternal and child dietary diversity, limited effects on agricultural production, and no effects on women and children's nutritional status. Our process evaluation explored fidelity, reach, and mechanisms behind interventions' effects. We also examined how context affected implementation, mechanisms, and outcomes. We used data from intervention monitoring systems, review notes, trial surveys, 32 case studies with families (n = 91 family members), and 20 group discussions with women's group members and intervention workers (n = 181 and 32, respectively). We found that interventions were implemented with high fidelity. Groups reached around half of the mothers of children under 2 years. Videos and meetings increased women's knowledge, motivation and confidence to suggest or make changes to their diets and agricultural production. Families responded in diverse ways. Many adopted or improved rainfed homestead garden cultivation for consumption, which could explain gains in maternal and child dietary diversity seen in the impact evaluation. Cultivation for income was less common. This was often due to small landholdings, poor access to irrigation and decision-making dominated by men. Interventions helped change norms about heavy work during pregnancy, but young women with little family support still did considerable work. Women's ability to shape cultivation, income and workload decisions was strongly influenced by support from male relatives. Future nutrition-sensitive agriculture interventions could include additional flexibility to address families' land, water, labour and time constraints, as well as actively engage with spouses and in-laws.

Community mobilisation to prevent violence against women and girls in eastern India through participatory learning and action with women's groups facilitated by accredited social health activists: a before-and-after pilot study.

BACKGROUND: Almost one in three married Indian women have ever experienced physical, sexual, or emotional violence from husbands in their lifetime. We aimed to investigate the preliminary effects of community mobilisation through participatory learning and action groups facilitated by Accredited Social Health Activists (ASHAs), coupled with access to counselling, to prevent violence against women and girls in Jharkhand, eastern India. METHODS: We piloted a cycle of 16 participatory learning and action meetings with women's groups facilitated by ASHAs in rural Jharkhand. Participants identified common forms of violence against women and girls, prioritised the ones they wanted to address, developed locally feasible strategies to address them, implemented the strategies, and evaluated the process. We also trained two counsellors and two ASHA supervisors to support survivors, and gave ASHAs information about legal, health, and police services. We did a before-and-after pilot study involving baseline and endline surveys with group members to estimate preliminary effects of these activities on the acceptability of violence, prevalence of past year emotional and physical violence, and help-seeking. RESULTS: ASHAs successfully conducted monthly participatory learning and action meetings with 39 women's groups in 22 villages of West Singhbhum district, Jharkhand, between June 2016 and September 2017. We interviewed 59% (679/1149) of women registered with groups at baseline, and 63% (861/1371) at endline. More women reported that violence was unacceptable in all seven scenarios presented to them at endline compared to baseline (adjusted Odds Ratio [aOR]: 1.87, 95%: 1.39-2.52). Fewer women reported experiencing emotional violence from their husbands in the last 12 months (aOR: 0.55, 95% CI: 0.43-0.71), and more sought help if it occurred (aOR: 2.19, 95% CI: 1.51-3.17). In addition, fewer women reported experiencing emotional or physical violence from family members other than their husbands in the last 12 months (aOR: 0.41, 95% CI: 0.32-0.53, and aOR: 0.36, 95% CI: 0.26-0.50, respectively). CONCLUSION: Combining participatory learning and action meetings facilitated by ASHAs with access to counselling was an acceptable strategy to address violence against women and girls in rural communities of Jharkhand. The approach warrants further implementation and evaluation as part of a comprehensive response to violence.

Agricultural and empowerment pathways from land ownership to women's nutrition in India.

Land size is an important equity concern for the design of 'nutrition-sensitive' agricultural interventions. We unpack some of the pathways between land and nutrition using a cross-sectional baseline survey data set of 4,480 women from 148 clusters from the 'Upscaling Participatory Action and Videos for Agriculture and Nutrition' trial in Keonjhar district in Odisha, India. Variables used are household ln-land size owned (exposure) and maternal dietary diversity score out of 10 food groups and body mass index (BMI; kg/m2 ) (outcomes); and mediators investigated are production diversity score, value of agricultural production, and indicators for women's empowerment (decision-making in agriculture, group participation, work-free time and land ownership). We assessed mediation using a non-parametric potential outcomes framework method. Land size positively affects maternal dietary diversity scores [ß 0.047; 95% confidence interval (CI) (0.011, 0.082)] but not BMI. Production diversity, but not value of production, accounts for 17.6% of total effect mediated. We observe suppression of the effect of land size on BMI, with no evidence of a direct effect for either of the agricultural mediators but indirect effects of ß -0.031 [95% CI (-0.048, -0.017)] through production diversity and ß -0.047 [95% CI (-0.075, -0.021)] through value of production. An increase in land size positively affects women's decision-making, which in turn negatively affects maternal BMI. The positive effect of work-free time on maternal BMI is suppressed by the negative effect of household land size on work-free time. Agriculture interventions must consider land quality, women's decision-making and implications for women's workload in their design.

Mortality and recovery following moderate and severe acute malnutrition in children aged 6-18 months in rural Jharkhand and Odisha, eastern India: A cohort study.

BACKGROUND: Recent data suggest that case fatality from severe acute malnutrition (SAM) in India may be lower than the 10%-20% estimated by the World Health Organization (WHO). A contemporary quantification of mortality and recovery from acute malnutrition in Indian community settings is essential to inform policy regarding the benefits of scaling up prevention and treatment programmes. METHODS AND FINDINGS: We conducted a cohort study using data collected during a recently completed cluster-randomised controlled trial in 120 geographical clusters with a total population of 121,531 in rural Jharkhand and Odisha, eastern India. Children born between October 1, 2013, and February 10, 2015, and alive at 6 months of age were followed up at 9, 12, and 18 months. We measured the children's anthropometry and asked caregivers whether children had been referred to services for malnutrition in the past 3 months. We determined the incidence and prevalence of moderate acute malnutrition (MAM) and SAM, as well as mortality and recovery at each follow-up. We then used Cox-proportional models to estimate mortality hazard ratios (HRs) for MAM and SAM. In total, 2,869 children were eligible for follow-up at 6 months of age. We knew the vital status of 93% of children (2,669/2,869) at 18 months. There were 2,704 children-years of follow-up time. The incidence of MAM by weight-for-length z score (WLZ) and/or mid-upper arm circumference (MUAC) was 406 (1,098/2,704) per 1,000 children-years. The incidence of SAM by WLZ, MUAC, or oedema was 190 (513/2,704) per 1,000 children-years. There were 36 deaths: 12 among children with MAM and six among children with SAM. Case fatality rates were 1.1% (12/1,098) for MAM and 1.2% (6/513) for SAM. In total, 99% of all children with SAM at 6 months of age (227/230) were alive 3 months later, 40% (92/230) were still SAM, and 18% (41/230) had recovered (WLZ ≥ -2 standard deviation [SD]; MUAC ≥ 12.5; no oedema). The adjusted HRs using all anthropometric indicators were 1.43 (95% CI 0.53-3.87, p = 0.480) for MAM and 2.56 (95% CI 0.99-6.70, p = 0.052) for SAM. Both WLZ < -3 and MUAC ≥ 11.5 and < 12.5 were associated with increased mortality risk (HR: 3.33, 95% CI 1.23-8.99, p = 0.018 and HR: 3.87, 95% CI 1.63-9.18, p = 0.002, respectively). A key limitation of our analysis was missing WLZ or MUAC data at all time points for 2.5% of children, including for two of the 36 children who died. CONCLUSIONS: In rural eastern India, the incidence of acute malnutrition among children older than 6 months was high, but case fatality following SAM was 1.2%, much lower than the 10%-20% estimated by WHO. Case fatality rates below 6% have now been recorded in three other Indian studies. Community treatment using ready-to-use therapeutic food may not avert a substantial number of SAM-related deaths in children aged over 6 months, as mortality in this group is lower than expected. Our findings strengthen the case for prioritising prevention through known health, nutrition, and multisectoral interventions in the first 1,000 days of life, while ensuring access to treatment when prevention fails.

Adolescent girls' health, nutrition and wellbeing in rural eastern India: a descriptive, cross-sectional community-based study.

BACKGROUND: India is home to 243 million adolescents. Two million (9%) of them belong to Scheduled Tribes living in underserved, rural areas. Few studies have examined the health of tribal adolescents. We conducted a cross-sectional survey to assess the health, nutrition and wellbeing of adolescent girls in rural Jharkhand, eastern India, a state where 26% of the population is from Scheduled Tribes. We aimed to identify priorities for community interventions to serve adolescents and their families. METHODS: Between June 2016 and January 2017, interviewers visited all households in 50 purposively sampled villages of West Singhbhum district, Jharkhand. They aimed to interview all girls aged 10-19. Interviewers conducted face-to-face interviews with girls to administer a survey about physical and mental health, disability, nutrition, sexual and reproductive health, gender norms, decision-making, education and violence. Interviewers also measured girls' height, weight, and Mid-Upper Arm Circumference. RESULTS: Interviewers collected data from 3324 (82%) of an estimated 4068 girls residing in the study area. Their mean age was 14.3 (SD 2.9). 82% were from Scheduled Tribes. 89% of younger girls aged 10-14 and 46% of older girls aged 15-19 were in school or college. Girls dropped out of school because they were required for household work (37%) or work on the family farm or business (22%). Over a third reported symptoms of anaemia in the past month, but less than a fifth had a blood test. The prevalence of thinness (<-2SD median BMI for age and sex) was 14% for younger girls and 6% for older girls. 45% of girls were stunted (<-2SD median height for age and sex). 40% reported emotional violence in the past year, 14% physical violence, and 0.7% sexual violence. 12% had problems associated with depression or anxiety. 30% aged 15-19 had heard of contraception. Among married girls and their husbands, only 10% had ever used methods to prevent or delay pregnancy. CONCLUSIONS: Our study identified several priorities to improve adolescent girls' health, nutrition and wellbeing in largely tribal areas of Jharkhand: reducing violence, early marriage and undernutrition, as well as improving mental health, knowledge about contraception and school retention.

Are village health sanitation and nutrition committees fulfilling their roles for decentralised health planning and action? A mixed methods study from rural eastern India.

BACKGROUND: In India, Village Health Sanitation and Nutrition Committees (VHSNCs) are participatory community health forums, but there is little information about their composition, functioning and effectiveness. Our study examined VHSNCs as enablers of participatory action for community health in two rural districts in two states of eastern India - West Singhbhum in Jharkhand and Kendujhar, in Odisha. METHODS: We conducted a cross-sectional survey of 169 VHSNCs and ten qualitative focus group discussions with purposively selected better and poorer performing committees, across the two states. We analysed the quantitative data using descriptive statistics and the qualitative data using a Framework approach. RESULTS: We found that VHSNCs comprised equitable representation from vulnerable groups when they were formed. More than 75 % members were women. Almost all members belonged to socially disadvantaged classes. Less than 1 % members had received any training. Supervision of committees by district or block officials was rare. Their work focused largely on strengthening village sanitation, conducting health awareness activities, and supporting medical treatment for ill or malnourished children and pregnant mothers. In reality, 62 % committees monitored community health workers, 6.5 % checked sub-centres and 2.4 % monitored drug availability with community health workers. Virtually none monitored data on malnutrition. Community health and nutrition workers acted as conveners and record keepers. Links with the community involved awareness generation and community monitoring of VHSNC activities. Key challenges included irregular meetings, members' limited understanding of their roles and responsibilities, restrictions on planning and fund utilisation, and weak linkages with the broader health system. CONCLUSIONS: Our study suggests that VHSNCs perform few of their specified functions for decentralized planning and action. If VHSNCs are to be instrumental in improving community health, sanitation and nutrition, they need education, mobilisation and monitoring for formal links with the wider health system.

Reactions to FDA-Proposed Graphic Warning Labels Affixed to U.S. Smokers' Cigarette Packs.

INTRODUCTION: Graphic warning labels have been shown to be more effective than text-only labels in increasing attention and perceived health risks, but most U.S. studies have involved single exposures in laboratory or Internet settings. METHODS: We recruited a convenience sample (N = 202) of U.S. adult smokers from population subgroups with higher rates of smoking and smoking-related deaths who had participated in a larger survey about graphic warning labels. Participants were randomized to get 1 of 9 graphic + text labels or a text-only label. Research staff affixed a warning label sticker to participants' cigarette pack(s) at enrollment. Color graphic labels covered slightly more than the lower half of packs. Black and white labels of current U.S. text-only warnings covered the existing side warning to prompt attention to the label (i.e., attention control). Participants received extra stickers of the same label for subsequent packs, and completed 3 telephone interviews in 1 week. RESULTS: Participants reported low avoidance (<34%) and consistent use of the stickers (91%). Smokers consistently paid more attention to graphic than text-only labels. Only 5 of the 9 graphic warning labels were significantly associated with greater thoughts of health risks. Thinking about quitting and stopping smoking did not differ by label. Qualitative data illustrated differences in the "stickiness," self-referencing, and counterarguments of graphic warning labels. CONCLUSIONS: U.S. smokers' reactions to graphic warning labels on their own packs were similar to other, more controlled studies. Qualitative findings underscore the need for warning labels that encourage self-referential processing without increasing defensive reactions.

Participatory women's groups and counselling through home visits to improve child growth in rural eastern India: protocol for a cluster randomised controlled trial.

BACKGROUND: Child stunting (low height-for-age) is a marker of chronic undernutrition and predicts children's subsequent physical and cognitive development. Around one third of the world's stunted children live in India. Our study aims to assess the impact, cost-effectiveness, and scalability of a community intervention with a government-proposed community-based worker to improve growth in children under two in rural India. METHODS: The study is a cluster randomised controlled trial in two rural districts of Jharkhand and Odisha (eastern India). The intervention tested involves a community-based worker carrying out two activities: (a) one home visit to all pregnant women in the third trimester, followed by subsequent monthly home visits to all infants aged 0-24 months to support appropriate feeding, infection control, and care-giving; (b) a monthly women's group meeting using participatory learning and action to catalyse individual and community action for maternal and child health and nutrition. Both intervention and control clusters also receive an intervention to strengthen Village Health Sanitation and Nutrition Committees. The unit of randomisation is a purposively selected cluster of approximately 1000 population. A total of 120 geographical clusters covering an estimated population of 121,531 were randomised to two trial arms: 60 clusters in the intervention arm receive home visits, group meetings, and support to Village Health Sanitation and Nutrition Committees; 60 clusters in the control arm receive support to Committees only. The study participants are pregnant women identified in the third trimester of pregnancy and their children (n = 2520). Mothers and their children are followed up at seven time points: during pregnancy, within 72 hours of delivery, and at 3, 6, 9, 12 and 18 months after birth. The trial's primary outcome is children's mean length-for-age Z scores at 18 months. Secondary outcomes include wasting and underweight at all time points, birth weight, growth velocity, feeding, infection control, and care-giving practices. Additional qualitative and quantitative data are collected for process and economic evaluations. DISCUSSION: This trial will contribute to evidence on effective strategies to improve children's growth in India. TRIAL REGISTRATION: ISRCTN register 51505201 ; Clinical Trials Registry of India number 2014/06/004664.

What can health communication science offer for ACA implementation? Five evidence-informed strategies for expanding Medicaid enrollment.

CONTEXT: Implementing the Affordable Care Act (ACA) in 2014 will require effective enrollment and outreach efforts to previously uninsured individuals now eligible for coverage. METHODS: From 1996 to 2013, the Health Communication Research Laboratory conducted more than 40 original studies with more than 30,000 participants to learn how to improve the reach to and effectiveness of health information for low-income and racial/ethnic minority populations. We synthesized the findings from this body of research and used them to inform current challenges in implementing the ACA. FINDINGS: We found empirical support for 5 recommendations regarding partnerships, outreach, messages and messengers, life priorities of low-income individuals and families, and the information environment. We translated these into 12 action steps. CONCLUSIONS: Health communication science can inform the development and execution of strategies to increase the public's understanding of the ACA and to support the enrollment of eligible individuals into Medicaid or the Health Insurance Marketplace.

The "long tail" and public health: new thinking for addressing health disparities.

The prevailing approach to improving population health focuses on shifting population means through a few targeted and universal interventions. The success of this approach for eliminating health disparities depends on an assumption about the distribution of demand for such interventions. We explored whether long tail thinking from business might yield greater progress in eliminating disparities. We examined 2011 to 2013 data from 513 state and local health agency representatives in 47 states who used an online system to create 4351 small media and client reminder products promoting colorectal cancer screening. Products in the long tail were more likely to target minority groups with higher rates of colorectal cancer and lower rates of screening than Whites. Long tail thinking could help improve the public's health and eliminate disparities.

Feasibility, acceptability and equity of a mobile intervention for Upscaling Participatory Action and Videos for Agriculture and Nutrition (m-UPAVAN) in rural Odisha, India.

Addressing undernutrition requires strategies that remove barriers to health for all. We adapted an intervention from the 'UPAVAN' trial to a mobile intervention (m-UPAVAN) during the COVID-19 pandemic in rural Odisha, India. In UPAVAN, women's groups viewed and discussed participatory videos on nutrition-specific and nutrition-sensitive agricultural (NSA) topics. In m-UPAVAN, weekly videos and audios on the same topics were disseminated via WhatsApp and an interactive voice response system. We assessed feasibility, acceptability, and equity of m-UPAVAN using a convergent parallel mixed-methods design. m-UPAVAN ran from Mar-Sept 2021 in 133 UPAVAN villages. In Feb-Mar 2021, we invited 1000 mothers of children aged 0-23 months to participate in a sociodemographic phone survey. Of those, we randomly sampled 200 mothers each month for five months for phone surveys to monitor progress against targets. Feasibility targets were met if >70% received videos/audios and >50% watched/listened at least once. Acceptability targets were met if >75% of those watching/listening liked the videos/audios and <20% opted out of the intervention. We investigated mothers' experiences of the intervention, including preferences for m-UPAVAN versus UPAVAN, using in-person, semi-structured interviews (n = 38). Of the 810 mothers we reached, 666 provided monitoring data at least once. Among these mothers, feasibility and acceptability targets were achieved. m-UPAVAN engaged whole families, which facilitated family-level discussions around promoted practices. Women valued the ability to access m-UPAVAN content on demand. This advantage did not apply to many mothers with limited phone access. Mothers highlighted that the UPAVAN interventions' in-person participatory approaches and longer videos were more conducive to learning and inclusive, and that mobile approaches provide important complementarity. We conclude that mobile NSA interventions are feasible and acceptable, can engage families, and reinforce learning. However, in-person participatory approaches remain essential for improving equity of NSA interventions. Investments are needed in developing and testing hybrid NSA interventions.

Improved neonatal survival after participatory learning and action with women's groups: a prospective study in rural eastern India.

OBJECTIVE: To determine whether a women's group intervention involving participatory learning and action has a sustainable and replicable effect on neonatal survival in rural, eastern India. METHODS: From 2004 to 2011, births and neonatal deaths in 36 geographical clusters in Jharkhand and Odisha were monitored. Between 2005 and 2008, these clusters were part of a randomized controlled trial of how women's group meetings involving participatory learning and action influence maternal and neonatal health. Between 2008 and 2011, groups in the original intervention clusters (zone 1) continued to meet to discuss post-neonatal issues and new groups in the original control clusters (zone 2) met to discuss neonatal health. Logistic regression was used to examine neonatal mortality rates after 2008 in the two zones. FINDINGS: Data on 41,191 births were analysed. In zone 1, the intervention's effect was sustained: the cluster-mean neonatal mortality rate was 34.2 per 1000 live births (95% confidence interval, CI: 28.3-40.0) between 2008 and 2011, compared with 41.3 per 1000 live births (95% CI: 35.4-47.1) between 2005 and 2008. The effect of the intervention was replicated in zone 2: the cluster-mean neonatal mortality rate decreased from 61.8 to 40.5 per 1000 live births between two periods: 2006-2008 and 2009-2011 (odds ratio: 0.69, 95% CI: 0.57-0.83). Hygiene during delivery, thermal care of the neonate and exclusive breastfeeding were important factors. CONCLUSION: The effect of participatory women's groups on neonatal survival in rural India, where neonatal mortality is high, was sustainable and replicable.

Effects of community youth teams facilitating participatory adolescent groups, youth leadership activities and livelihood promotion to improve school attendance, dietary diversity and mental health among adolescent girls in rural eastern India (JIAH trial): A cluster-randomised controlled trial.

Objectives: To evaluate whether and how community youth teams facilitating participatory adolescent groups, youth leadership and livelihood promotion improved school attendance, dietary diversity, and mental health among adolescent girls in rural India. Design: A parallel group, two-arm, superiority, cluster-randomised controlled trial with an embedded process evaluation. Setting intervention and participants: 38 clusters (19 intervention, 19 control) in West Singhbhum district in Jharkhand, India. The intervention included participatory adolescent groups and youth leadership for boys and girls aged 10-19 (intervention clusters only), and family-based livelihood promotion (intervention and control clusters) between June 2017 and March 2020. We surveyed 3324 adolescent girls aged 10-19 in 38 clusters at baseline, and 1478 in 29 clusters at endline. Four intervention and five control clusters were lost to follow up when the trial was suspended due to the COVID-19 pandemic. Adolescent boys were included in the process evaluation only. Primary and secondary outcome measures: Primary: school attendance, dietary diversity, and mental health; 12 secondary outcomes related to education, empowerment, experiences of violence, and sexual and reproductive health. Results: In intervention vs control clusters, mean dietary diversity score was 4·0 (SD 1·5) vs 3·6 (SD 1·2) (adjDiff 0·34; 95%CI -0·23, 0·93, p = 0·242); mean Brief Problem Monitor-Youth (mental health) score was 12·5 (SD 6·0) vs 11·9 (SD 5·9) (adjDiff 0·02, 95%CI -0·06, 0·13, p = 0·610); and school enrolment rates were 70% vs 63% (adjOR 1·39, 95%CI 0·89, 2·16, p = 0·142). Uptake of school-based entitlements was higher in intervention clusters (adjOR 2·01; 95%CI 1·11, 3·64, p = 0·020). Qualitative data showed that the community youth team had helped adolescents and their parents navigate school bureaucracy, facilitated re-enrolments, and supported access to entitlements. Overall intervention delivery was feasible, but positive impacts were likely undermined by household poverty. Conclusions: Participatory adolescent groups, leadership training and livelihood promotion delivered by a community youth team did not improve adolescent girls' mental health, dietary diversity, or school attendance in rural India, but may have increased uptake of education-related entitlements. Trial registration: ISRCTN17206016.

Economic evaluation of participatory women's groups scaled up by the public health system to improve birth outcomes in Jharkhand, eastern India.

An estimated 2.4 million newborn infants died in 2020, 80% of them in sub-Saharan Africa and South Asia. To achieve the Sustainable Development Target for neonatal mortality reduction, countries with high mortality need to implement evidence-based, cost-effective interventions at scale. Our study aimed to estimate the cost, cost-effectiveness, and benefit-cost ratio of a participatory women's groups intervention scaled up by the public health system in Jharkhand, eastern India. The intervention was evaluated through a pragmatic cluster non-randomised controlled trial in six districts. We estimated the cost of the intervention at scale from a provider perspective, with a 42-month time horizon for 20 districts. We estimated costs using a combination of top-down and bottom-up approaches. All costs were adjusted for inflation, discounted at 3% per year, and converted to 2020 International Dollars (INT$). Incremental cost-effectiveness ratios (ICERs) were estimated using extrapolated effect sizes for the impact of the intervention in 20 districts, in terms of cost per neonatal deaths averted and cost per life year saved. We assessed the impact of uncertainty on results through one-way and probabilistic sensitivity analyses. We also estimated benefit-cost ratio using a benefit transfer approach. Total intervention costs for 20 districts were INT$ 15,017,396. The intervention covered an estimated 1.6 million livebirths across 20 districts, translating to INT$ 9.4 per livebirth covered. ICERs were estimated at INT$ 1,272 per neonatal death averted or INT$ 41 per life year saved. Net benefit estimates ranged from INT$ 1,046 million to INT$ 3,254 million, and benefit-cost ratios from 71 to 218. Our study suggests that participatory women's groups scaled up by the Indian public health system were highly cost-effective in improving neonatal survival and had a very favourable return on investment. The intervention can be scaled up in similar settings within India and other countries.

Effect of a participatory intervention with women's groups on birth outcomes and maternal depression in Jharkhand and Orissa, India: a cluster-randomised controlled trial.

BACKGROUND: Community mobilisation through participatory women's groups might improve birth outcomes in poor rural communities. We therefore assessed this approach in a largely tribal and rural population in three districts in eastern India. METHODS: From 36 clusters in Jharkhand and Orissa, with an estimated population of 228 186, we assigned 18 clusters to intervention or control using stratified randomisation. Women were eligible to participate if they were aged 15-49 years, residing in the project area, and had given birth during the study. In intervention clusters, a facilitator convened 13 groups every month to support participatory action and learning for women, and facilitated the development and implementation of strategies to address maternal and newborn health problems. The primary outcomes were reductions in neonatal mortality rate (NMR) and maternal depression scores. Analysis was by intention to treat. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN21817853. FINDINGS: After baseline surveillance of 4692 births, we monitored outcomes for 19 030 births during 3 years (2005-08). NMRs per 1000 were 55.6, 37.1, and 36.3 during the first, second, and third years, respectively, in intervention clusters, and 53.4, 59.6, and 64.3, respectively, in control clusters. NMR was 32% lower in intervention clusters adjusted for clustering, stratification, and baseline differences (odds ratio 0.68, 95% CI 0.59-0.78) during the 3 years, and 45% lower in years 2 and 3 (0.55, 0.46-0.66). Although we did not note a significant effect on maternal depression overall, reduction in moderate depression was 57% in year 3 (0.43, 0.23-0.80). INTERPRETATION: This intervention could be used with or as a potential alternative to health-worker-led interventions, and presents new opportunities for policy makers to improve maternal and newborn health outcomes in poor populations. FUNDING: Health Foundation, UK Department for International Development, Wellcome Trust, and the Big Lottery Fund (UK).

Effectiveness of participatory women's groups scaled up by the public health system to improve birth outcomes in Jharkhand, eastern India: a pragmatic cluster non-randomised controlled trial.

INTRODUCTION: The WHO recommends community mobilisation with women's groups practising participatory learning and action (PLA) to improve neonatal survival in high-mortality settings. This intervention has not been evaluated at scale with government frontline workers. METHODS: We did a pragmatic cluster non-randomised controlled trial of women's groups practising PLA scaled up by government front-line workers in Jharkhand, eastern India. Groups prioritised maternal and newborn health problems, identified strategies to address them, implemented the strategies and evaluated progress. Intervention coverage and quality were tracked state-wide. Births and deaths to women of reproductive age were monitored in six of Jharkhand's 24 districts: three purposively allocated to an early intervention start (2017) and three to a delayed start (2019). We monitored vital events prospectively in 100 purposively selected units of 10 000 population each, during baseline (1 March 2017-31 August 2017) and evaluation periods (1 September 2017-31 August 2019). The primary outcome was neonatal mortality. RESULTS: We identified 51 949 deliveries and conducted interviews for 48 589 (93.5%). At baseline, neonatal mortality rates (NMR) were 36.9 per 1000 livebirths in the early arm and 39.2 in the delayed arm. Over 24 months of intervention, the NMR was 29.1 in the early arm and 39.2 in the delayed arm, corresponding to a 24% reduction in neonatal mortality (adjusted OR (AOR) 0.76, 95% CI 0.59 to 0.98), including 26% among the most deprived (AOR 0.74, 95% CI 0.57 to 0.95). Twenty of Jharkhand's 24 districts achieved adequate meeting coverage and quality. In these 20 districts, the intervention saved an estimated 11 803 newborn lives (min: 1026-max: 20 527) over 42 months, and cost 41 international dollars per life year saved. CONCLUSION: Participatory women's groups scaled up by the Indian public health system reduced neonatal mortality equitably in a largely rural state and were highly cost-effective, warranting scale-up in other high-mortality rural settings. TRIAL REGISTRATION: ISRCTN99422435.

Effect of nutrition-sensitive agriculture interventions with participatory videos and women's group meetings on maternal and child nutritional outcomes in rural Odisha, India (UPAVAN trial): a four-arm, observer-blind, cluster-randomised controlled trial.

BACKGROUND: Almost a quarter of the world's undernourished people live in India. We tested the effects of three nutrition-sensitive agriculture (NSA) interventions on maternal and child nutrition in India. METHODS: We did a parallel, four-arm, observer-blind, cluster-randomised trial in Keonjhar district, Odisha, India. A cluster was one or more villages with a combined minimum population of 800 residents. The clusters were allocated 1:1:1:1 to a control group or an intervention group of fortnightly women's groups meetings and household visits over 32 months using: NSA videos (AGRI group); NSA and nutrition-specific videos (AGRI-NUT group); or NSA videos and a nutrition-specific participatory learning and action (PLA) cycle meetings and videos (AGRI-NUT+PLA group). Primary outcomes were the proportion of children aged 6-23 months consuming at least four of seven food groups the previous day and mean maternal body-mass index (BMI). Secondary outcomes were proportion of mothers consuming at least five of ten food groups and child wasting (proportion of children with weight-for-height Z score SD <-2). Outcomes were assessed in children and mothers through cross-sectional surveys at baseline and at endline, 36 months later. Analyses were by intention to treat. Participants and intervention facilitators were not blinded to allocation; the research team were. This trial is registered at ISRCTN, ISRCTN65922679. FINDINGS: 148 of 162 clusters assessed for eligibility were enrolled and randomly allocated to trial groups (37 clusters per group). Baseline surveys took place from Nov 24, 2016, to Jan 24, 2017; clusters were randomised from December, 2016, to January, 2017; and interventions were implemented from March 20, 2017, to Oct 31, 2019, and endline surveys done from Nov 19, 2019, to Jan 12, 2020, in an average of 32 households per cluster. All clusters were included in the analyses. There was an increase in the proportion of children consuming at least four of seven food groups in the AGRI-NUT (adjusted relative risk [RR] 1·19, 95% CI 1·03 to 1·37, p=0·02) and AGRI-NUT+PLA (1·27, 1·11 to 1·46, p=0·001) groups, but not AGRI (1·06, 0·91 to 1·23, p=0·44), compared with the control group. We found no effects on mean maternal BMI (adjusted mean differences vs control, AGRI -0·05, -0·34 to 0·24; AGRI-NUT 0·04, -0·26 to 0·33; AGRI-NUT+PLA -0·03, -0·3 to 0·23). An increase in the proportion of mothers consuming at least five of ten food groups was seen in the AGRI (adjusted RR 1·21, 1·01 to 1·45) and AGRI-NUT+PLA (1·30, 1·10 to 1·53) groups compared with the control group, but not in AGRI-NUT (1·16, 0·98 to 1·38). We found no effects on child wasting (adjusted RR vs control, AGRI 0·95, 0·73 to 1·24; AGRI-NUT 0·96, 0·72 to 1·29; AGRI-NUT+PLA 0·96, 0·73 to 1·26). INTERPRETATION: Women's groups using combinations of NSA videos, nutrition-specific videos, and PLA cycle meetings improved maternal and child diet quality in rural Odisha, India. These components have been implemented separately in several low-income settings; effects could be increased by scaling up together. FUNDING: Bill & Melinda Gates Foundation, UK AID from the UK Government, and US Agency for International Development.

Explaining the impact of a women's group led community mobilisation intervention on maternal and newborn health outcomes: the Ekjut trial process evaluation.

BACKGROUND: Few large and rigorous evaluations of participatory interventions systematically describe their context and implementation, or attempt to explain the mechanisms behind their impact. This study reports process evaluation data from the Ekjut cluster-randomised controlled trial of a participatory learning and action cycle with women's groups to improve maternal and newborn health outcomes in Jharkhand and Orissa, eastern India (2005-2008). The study demonstrated a 45% reduction in neonatal mortality in the last two years of the intervention, largely driven by improvements in safe practices for home deliveries. METHODS: A participatory learning and action cycle with 244 women's groups was implemented in 18 intervention clusters covering an estimated population of 114 141. We describe the context, content, and implementation of this intervention, identify potential mechanisms behind its impact, and report challenges experienced in the field. Methods included a review of intervention documents, qualitative structured discussions with group members and non-group members, meeting observations, as well as descriptive statistical analysis of data on meeting attendance, activities, and characteristics of group attendees. RESULTS: Six broad, interrelated factors influenced the intervention's impact: (1) acceptability; (2) a participatory approach to the development of knowledge, skills and 'critical consciousness'; (3) community involvement beyond the groups; (4) a focus on marginalized communities; (5) the active recruitment of newly pregnant women into groups; (6) high population coverage. We hypothesize that these factors were responsible for the increase in safe delivery and care practices that led to the reduction in neonatal mortality demonstrated in the Ekjut trial. CONCLUSIONS: Participatory interventions with community groups can influence maternal and child health outcomes if key intervention characteristics are preserved and tailored to local contexts. Scaling-up such interventions requires (1) a detailed understanding of the way in which context affects the acceptability and delivery of the intervention; (2) planned but flexible replication of key content and implementation features; (3) strong support for participatory methods from implementing agencies.