Individual interventions, collective lessons: Developing mid-range theory on women's groups to improve health.

Background: Interventions with women's groups have been widely implemented to improve health outcomes in low- and middle-income settings, particularly India. While there is a large evidence base on the effectiveness of single interventions, it is challenging to predict whether a women's group intervention delivered in one setting can be expected to work in another. Methods: We applied realist principles to develop and refine a mid-range theory on the effectiveness of women's groups interventions, summarised key lessons for implementation, and reflected on the process. We synthesised primary data from several interventions in India, a systematic review, and an analysis of behaviour change techniques. We developed mid-range theories across three areas: maternal and newborn health, nutrition, and violence against women, as well as an overarching mid-range theory on how women's groups can improve health. Results: Our overarching mid-range theory suggested that effective interventions should: build group or community capabilities; focus on health outcomes relevant to group members; and approach health issues modifiable through women's individual or collective actions. We identified four key lessons for future interventions with women's groups, including the importance of skilled and remunerated facilitation, sufficient intensity, supply-side strengthening, and the need to adapt delivery during scale up while maintaining fidelity to intervention theory. Conclusions: Our experience demonstrated the feasibility of developing mid-range theory from a combination of evidence and insights from practice. It also underscored the importance of community engagement and ongoing research to 'thicken' mid-range theories to design effective and scalable women's groups interventions in India and similar settings.

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.

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.

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.

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.

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.

Socioeconomic inequalities in stillbirth and neonatal mortality rates: evidence on Particularly Vulnerable Tribal Groups in eastern India.

BACKGROUND: Tribal peoples are among the most marginalised groups worldwide. Evidence on birth outcomes in these groups is scant. We describe inequalities in Stillbirth Rate (SBR), Neonatal Mortality Rate (NMR), and uptake of maternal and newborn health services between tribal and less disadvantaged groups in eastern India, and examine the contribution of poverty and education to these inequalities. METHODS: We used data from a demographic surveillance system covering a 1 million population in Jharkhand State (March 2017 - August 2019) to describe SBR, NMR, and service uptake. We used logistic regression analysis combined with Stata's adjrr-command to estimate absolute and relative inequalities by caste/tribe (comparing Particularly Vulnerable Tribal Groups (PVTG) and other Scheduled Tribes (ST) with the less marginalised Other Backward Class (OBC)/none, using the Indian government classification), and by maternal education and household wealth. RESULTS: PVTGs had a higher NMR (59/1000) than OBC/none (31/1000) (rate ratio (RR): 1.92, 95%CI: 1.55-2.38). This was partly explained by wealth and education, but inequalities remained large after adjustment (adjusted RR: 1.59, 95%CI: 1.28-1.98). NMR was also higher among other STs (44/1000), but disparities were smaller (RR: 1.47, 95%CI: 1.23-1.75). There was a systematic gradient in NMR by maternal education and household wealth. SBRs were only higher in poorer groups (RRpoorest vs. least poor:1.56, 95%CI: 1.14-2.13). Uptake of facility-based services was low among PVTGs (e.g. institutional birth: 25% vs. 69% in OBC/none) and among poorer and less educated women. However, 65% of PVTG women with an institutional birth used a maternity vehicle vs. 34% among OBC/none. Visits from frontline workers (Accredited Social Health Activists [ASHAs]) were similar across groups, and ASHA accompaniment of institutional births was similar across caste/tribe groups, and higher among poorer and less educated women. Attendance in participatory women's groups was similar across caste/tribe groups, and somewhat higher among richer and better educated women. CONCLUSIONS: PVTGs are highly disadvantaged in terms of birth outcomes. Targeted interventions that reduce geographical barriers to facility-based care and address root causes of high poverty and low education in PVTGs are a priority. For population-level impact, they are to be combined with broader policies to reduce socio-economic mortality inequalities. Community-based interventions reach disadvantaged groups and have potential to reduce the mortality gap.

Mitofusin-2 Negatively Regulates Melanogenesis by Modulating Mitochondrial ROS Generation.

Inter-organellar communication is emerging as one of the most crucial regulators of cellular physiology. One of the key regulators of inter-organellar communication is Mitofusin-2 (MFN2). MFN2 is also involved in mediating mitochondrial fusion-fission dynamics. Further, it facilitates mitochondrial crosstalk with the endoplasmic reticulum, lysosomes and melanosomes, which are lysosome-related organelles specialized in melanin synthesis within melanocytes. However, the role of MFN2 in regulating melanocyte-specific cellular function, i.e., melanogenesis, remains poorly understood. Here, using a B16 mouse melanoma cell line and primary human melanocytes, we report that MFN2 negatively regulates melanogenesis. Both the transient and stable knockdown of MFN2 leads to enhanced melanogenesis, which is associated with an increase in the number of mature (stage III and IV) melanosomes and the augmented expression of key melanogenic enzymes. Further, the ectopic expression of MFN2 in MFN2-silenced cells leads to the complete rescue of the phenotype at the cellular and molecular levels. Mechanistically, MFN2-silencing elevates mitochondrial reactive-oxygen-species (ROS) levels which in turn increases melanogenesis. ROS quenching with the antioxidant N-acetyl cysteine (NAC) reverses the MFN2-knockdown-mediated increase in melanogenesis. Moreover, MFN2 expression is significantly lower in the darkly pigmented primary human melanocytes in comparison to lightly pigmented melanocytes, highlighting a potential contribution of lower MFN2 levels to higher physiological pigmentation. Taken together, our work establishes MFN2 as a novel negative regulator of melanogenesis.

Superior even skin tone and anti-ageing benefit of a combination of 4-hexylresorcinol and niacinamide.

OBJECTIVES: To demonstrate the synergistic effect of 4-hexylresorcinol (4-HR) with niacinamide in boosting anti-melanogenic efficacy in vitro and establish the in vivo efficacy and safety of the combination in a human trial. METHODS: Primary human epidermal melanocytes and 3D pigmented skin equivalents were treated with 4-HR, niacinamide, and their combinations for their effect on pigmentation. This was followed by a randomized, double-blind, split-face clinical study in Chinese subjects, and effects on skin tone, hyperpigmentation, fine lines and wrinkles, hydration, and skin firmness were measured for a 12-week study period. RESULTS: In vitro tyrosinase enzyme activity studies showed that 4-HR is one of the most potent tyrosinase inhibitors. The combination of 4-HR and niacinamide showed a synergistic reduction in melanin production in cultured melanocytes and lightened the 3D skin equivalent model. In vitro as well as in the human trial, the combination of 4-HR and niacinamide showed significantly improved efficacy over niacinamide alone on hyperpigmentation spots as measured by L*, the visual appearance of fine lines and wrinkles in crow's feet and perioral area and skin firmness, with no product-related adverse events. CONCLUSIONS: A formulation containing a combination of 4-HR and niacinamide delivered superior skin tone and anti-ageing benefits significantly better than niacinamide alone with no adverse events. This study demonstrates that a product designed to affect multiple pathways of melanogenesis, inflammation, and ageing may provide an additional treatment option, beyond hydroquinone and retinoids, for hyperpigmentation and ageing.

OBJECTIFS: Démontrer l'effet synergique du 4-hexylrésorcinol (4-HR) associé au niacinamide pour stimuler in vitro l'efficacité antimélanogène, et établir l'efficacité et la sécurité d'emploi in vivo de cette association dans un essai chez l'homme. MÉTHODES: Des mélanocytes épidermiques humains primaires et des équivalents cutanés pigmentés en 3D ont été traités avec du 4-HR, du niacinamide et leurs combinaisons pour leur effet sur la pigmentation. Ceci a été suivi d'une étude clinique randomisée, en double aveugle en hémi-visage chez des sujets chinois, et les effets sur le teint, l'hyperpigmentation, les rides et ridules, l'hydratation et la fermeté de la peau ont été mesurés pendant une durée d'étude de 12 semaines. RÉSULTATS: Les études in vitro sur l'activité enzymatique de la tyrosinase ont montré que le 4-HR est l'un des inhibiteurs de la tyrosinase les plus puissants. L'association du 4-HR et du niacinamide a montré une réduction synergique de la production de mélanine dans les mélanocytes de culture et donné de la luminosité au modèle cutané 3D équivalent. Également in vitro avec l'étude chez l'homme, l'association du 4-HR et du niacinamide a fait ressortir une efficacité significativement plus élevée qu'avec le niacinamide seul sur les taches d'hyperpigmentation mesurées par L*, l'aspect visuel des rides et ridules des pattes d'oie et de la zone périorale, et la fermeté de la peau, sans événements indésirables liés au produit. CONCLUSIONS: Une formulation contenant une association de 4-HR et de niacinamide a permis d'obtenir un teint et un effet anti-âge nettement supérieurs à ceux du niacinamide seul, sans événements indésirables. Cette étude démontre qu'un produit conçu pour toucher plusieurs voies de mélanogenèse, d'inflammation et de vieillissement peut constituer une nouvelle option thérapeutique, au-delà de l'hydroquinone et des rétinoïdes, pour l'hyperpigmentation et le vieillissement.

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.

How to design a complex behaviour change intervention: experiences from a nutrition-sensitive agriculture trial in rural India.

Many public health interventions aim to promote healthful behaviours, with varying degrees of success. With a lack of existing empirical evidence on the optimal number or combination of behaviours to promote to achieve a given health outcome, a key challenge in intervention design lies in deciding what behaviours to prioritise, and how best to promote them. We describe how key behaviours were selected and promoted within a multisectoral nutrition-sensitive agriculture intervention that aimed to address maternal and child undernutrition in rural India. First, we formulated a Theory of Change, which outlined our hypothesised impact pathways. To do this, we used the following inputs: existing conceptual frameworks, published empirical evidence, a feasibility study, formative research and the intervention team's local knowledge. Then, we selected specific behaviours to address within each impact pathway, based on our formative research, behaviour change models, local knowledge and community feedback. As the intervention progressed, we mapped each of the behaviours against our impact pathways and the transtheoretical model of behaviour change, to monitor the balance of behaviours across pathways and along stages of behaviour change. By collectively agreeing on definitions of complex concepts and hypothesised impact pathways, implementing partners were able to communicate clearly between each other and with intervention participants. Our intervention was iteratively informed by continuous review, by monitoring implementation against targets and by integrating community feedback. Impact and process evaluations will reveal whether these approaches are effective for improving maternal and child nutrition, and what the effects are on each hypothesised impact pathway.

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.

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: protocol for a cluster-randomised controlled trial.

BACKGROUND: Improving the health and development of adolescents aged 10-19 years is a global health priority. One in five adolescents globally live in India. The Rashtriya Kishor Swasthya Karyakram (RKSK), India's national adolescent health strategy, recommends supporting community-based peer educators to conduct group meetings with boys and girls. Groups aim to give adolescents a space to discuss the social and health issues affecting them and build their capacity to become active community members and leaders. There have been no evaluations of the community component of RKSK to date. In this protocol, we describe the evaluation of the Jharkhand Initiative for Adolescent Health (JIAH), a community intervention aligned with RKSK and designed to improve school attendance, dietary diversity and mental health among adolescent girls aged 10-19 years in rural Jharkhand, eastern India. METHODS: The JIAH intervention is delivered by a community youth team consisting of yuva saathis (friends of youth), youth leadership facilitators and livelihood promoters. Teams conduct (a) peer-led Participatory Learning and Action meetings with girls and boys, mobilising adolescents, parents, health workers, teachers and the wider community to make changes for adolescent health and development; (b) group-based youth leadership activities to build adolescents' confidence and resilience; and (c) livelihood promotion with adolescents and their families to provide training and practical skills. We are evaluating the JIAH intervention through a parallel-group, two-arm, superiority, cluster-randomised controlled trial. The unit of randomisation is a geographic cluster of ~1000 people. A total of 38 clusters covering an estimated population of 40,676 have been randomised to control or intervention arms. Nineteen intervention clusters have adolescent groups, youth leadership activities and livelihood promotion. Nineteen control clusters receive livelihood promotion only. Study participants are adolescent girls aged 10-19 years, married or unmarried, in or out of school, living in the study area. Intervention activities are open to all adolescent boys and girls, regardless of their participation in surveys. We will collect data through baseline and endline surveys. Primary trial outcomes are school attendance, dietary diversity and internalising and externalising mental health problems. Secondary outcomes include access to school-related entitlements, emotional or physical violence, self-efficacy and resilience. TRIAL REGISTRATION: ISRCTN17206016. Registered on 27 June 2018.

Integrated multisectoral strategy to improve girls' and women's nutrition before conception, during pregnancy and after birth in India (Swabhimaan): protocol for a prospective, non-randomised controlled evaluation.

INTRODUCTION: Swabhimaan is a community-based programme to improve adolescent girls' and women's nutrition in the rural areas of three Indian states-Bihar, Chhattisgarh and Odisha with high prevalence of undernutrition. METHODS AND ANALYSIS: Swabhimaan has a nested prospective, non-randomised controlled evaluation. Since 2017, five intervention sites receive community-led interventions through national government's livelihood mission supported women's self-help group federations and five control sites will initiate these activities 36 months later, in 2020. Community-led activities aim to improve coverage of 18 interventions including adequacy of food consumed, prevention of micronutrient deficiencies, access to basic health services and special care of nutritionally 'at risk' girls and women, improving hygiene and access to water and sanitation services and access to family planning services. The evaluation includes baseline (2016-2017), midline (2018-2019) and endline (2020-2021) surveys covering 6638 adolescent girls, 2992 pregnant women and 8755 mothers of children under 2. The final impact analysis will be by intention to treat, comparing primary and secondary outcomes in five intervention areas and five control areas. The primary outcomes are: (1) a 15% reduction in the proportion of adolescent girls with a body mass index (BMI) <18.5 kg/m2; (2) a 15% reduction in the proportion of mothers of children under two with a BMI <18.5 kg/m2 and (3) and a 0.4 cm improvement in mean mid-upper arm circumference among pregnant women. ETHICS AND DISSEMINATION: All procedures involving human subjects were approved by the Institutional Ethics Committee of the All India Institute of Medical Sciences, Bihar, Chhattisgarh and Odisha and in compliance with guidelines laid down in the Declaration of Helsinki. Evidence will inform maternal and preconception nutrition policy at national and state level. TRIAL REGISTRATION NUMBER: 58261b2f46876 and CTRI/2016/11/007482; Pre-results.

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.

In vivo multiphoton microscopy of melasma.

Melasma is a skin disorder characterized by hyperpigmented patches due to increased melanin production and deposition. In this pilot study, we evaluate the potential of multiphoton microscopy (MPM) to characterize non-invasively the melanin content, location, and distribution in melasma and assess the elastosis severity. We employed a clinical MPM tomograph to image in vivo morphological features in melasma lesions and adjacent normal skin in 12 patients. We imaged dermal melanophages in most dermal melasma lesions and occasionally in epidermal melasma. The melanin volume fraction values measured in epidermal melasma (14% ± 4%) were significantly higher (p < 0.05) than the values measured in perilesional skin (11% ± 3%). The basal keratinocytes of melasma and perilesions showed different melanin distribution. Elastosis was predominantly more severe in lesions than in perilesions and was associated with changes in melanin distribution of the basal keratinocytes. These results demonstrate that MPM may be a non-invasive imaging tool for characterizing melasma.

Upscaling Participatory Action and Videos for Agriculture and Nutrition (UPAVAN) trial comparing three variants of a nutrition-sensitive agricultural extension intervention to improve maternal and child nutritional outcomes in rural Odisha, India: study protocol for a cluster randomised controlled trial.

BACKGROUND: Maternal and child undernutrition have adverse consequences for pregnancy outcomes and child morbidity and mortality, and they are associated with low educational attainment, economic productivity as an adult, and human wellbeing. 'Nutrition-sensitive' agriculture programs could tackle the underlying causes of undernutrition. METHODS/DESIGN: This study is a four-arm cluster randomised controlled trial in Odisha, India. Interventions are as follows: (1) an agricultural extension platform of women's groups viewing and discussing videos on nutrition-sensitive agriculture (NSA) practices, and follow-up visits to women at home to encourage the adoption of new practices shown in the videos; (2) women's groups viewing and discussing videos on NSA and nutrition-specific practices, with follow-up visits; and (3) women's groups viewing and discussing videos on NSA and nutrition-specific practices combined with a cycle of Participatory Learning and Action meetings, with follow-up visits. All arms, including the control, receive basic nutrition training from government community frontline workers. Primary outcomes, assessed at baseline and 32 months after the start of the interventions, are (1) percentage of children aged 6-23 months consuming ≥ 4 out of 7 food groups per day and (2) mean body mass index (BMI) (kg/m2) of non-pregnant, non-postpartum (gave birth > 42 days ago) mothers or female primary caregivers of children aged 0-23 months. Secondary outcomes are percentage of mothers consuming ≥ 5 out of 10 food groups per day and percentage of children's weight-for-height z-score < -2 standard deviations (SD). The unit of randomisation is a cluster, defined as one or more villages with a combined minimum population of 800 residents. There are 37 clusters per arm, and outcomes will be assessed in an average of 32 eligible households per cluster. For randomisation, clusters are stratified by distance to nearest town (< 10 km or ≥ 10 km), and low (< 30%), medium (30-70%), or high (> 70%) proportion of Scheduled Tribe or Scheduled Caste (disadvantaged) households. A process evaluation will assess the quality of implementation and mechanisms behind the intervention effects. A cost-consequence analysis will compare incremental costs and outcomes of the interventions. DISCUSSION: This trial will contribute evidence on the impacts of NSA extension through participatory, low-cost, video-based approaches on maternal and child nutrition and on whether integration with nutrition-specific goals and enhanced participatory approaches can increase these impacts. TRIAL REGISTRATION: ISRCTN , ISRCTN65922679 . Registered on 21 December 2016.