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      Impact on birth weight and child growth of Participatory Learning and Action women’s groups with and without transfers of food or cash during pregnancy: Findings of the low birth weight South Asia cluster-randomised controlled trial (LBWSAT) in Nepal

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          Abstract

          Background

          Undernutrition during pregnancy leads to low birthweight, poor growth and inter-generational undernutrition. We did a non-blinded cluster-randomised controlled trial in the plains districts of Dhanusha and Mahottari, Nepal to assess the impact on birthweight and weight-for-age z-scores among children aged 0–16 months of community-based participatory learning and action (PLA) women’s groups, with and without food or cash transfers to pregnant women.

          Methods

          We randomly allocated 20 clusters per arm to four arms (average population/cluster = 6150). All consenting married women aged 10–49 years, who had not had tubal ligation and whose husbands had not had vasectomy, were monitored for missed menses. Between 29 Dec 2013 and 28 Feb 2015 we recruited 25,092 pregnant women to surveillance and interventions: PLA alone (n = 5626); PLA plus food (10 kg/month of fortified wheat-soya ‘Super Cereal’, n = 6884); PLA plus cash (NPR750≈US$7.5/month, n = 7272); control (existing government programmes, n = 5310). 539 PLA groups discussed and implemented strategies to improve low birthweight, nutrition in pregnancy and hand washing. Primary outcomes were birthweight within 72 hours of delivery and weight-for-age z-scores at endline (age 0–16 months). Only children born to permanent residents between 4 June 2014 and 20 June 2015 were eligible for intention to treat analyses (n = 10936), while in-migrating women and children born before interventions had been running for 16 weeks were excluded. Trial status: completed.

          Results

          In PLA plus food/cash arms, 94–97% of pregnant women attended groups and received a mean of four transfers over their pregnancies. In the PLA only arm, 49% of pregnant women attended groups. Due to unrest, the response rate for birthweight was low at 22% (n = 2087), but response rate for endline nutritional and dietary measures exceeded 83% (n = 9242). Compared to the control arm (n = 464), mean birthweight was significantly higher in the PLA plus food arm by 78·0 g (95% CI 13·9, 142·0; n = 626) and not significantly higher in PLA only and PLA plus cash arms by 28·9 g (95% CI -37·7, 95·4; n = 488) and 50·5 g (95% CI -15·0, 116·1; n = 509) respectively. Mean weight-for-age z-scores of children aged 0–16 months (average age 9 months) sampled cross-sectionally at endpoint, were not significantly different from those in the control arm (n = 2091). Differences in weight for-age z-score were as follows: PLA only -0·026 (95% CI -0·117, 0·065; n = 2095); PLA plus cash -0·045 (95% CI -0·133, 0·044; n = 2545); PLA plus food -0·033 (95% CI -0·121, 0·056; n = 2507). Amongst many secondary outcomes tested, compared with control, more institutional deliveries (OR: 1.46 95% CI 1.03, 2.06; n = 2651) and less colostrum discarding (OR:0.71 95% CI 0.54, 0.93; n = 2548) were found in the PLA plus food arm but not in PLA alone or in PLA plus cash arms.

          Interpretation

          Food supplements in pregnancy with PLA women’s groups increased birthweight more than PLA plus cash or PLA alone but differences were not sustained. Nutrition interventions throughout the thousand-day period are recommended.

          Trial registration

          ISRCTN75964374.

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          Most cited references52

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          Maternal and child undernutrition and overweight in low-income and middle-income countries

          The Lancet, 382(9890), 427-451
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            Maternal and child undernutrition: consequences for adult health and human capital

            Summary In this paper we review the associations between maternal and child undernutrition with human capital and risk of adult diseases in low-income and middle-income countries. We analysed data from five long-standing prospective cohort studies from Brazil, Guatemala, India, the Philippines, and South Africa and noted that indices of maternal and child undernutrition (maternal height, birthweight, intrauterine growth restriction, and weight, height, and body-mass index at 2 years according to the new WHO growth standards) were related to adult outcomes (height, schooling, income or assets, offspring birthweight, body-mass index, glucose concentrations, blood pressure). We undertook systematic reviews of studies from low-income and middle-income countries for these outcomes and for indicators related to blood lipids, cardiovascular disease, lung and immune function, cancers, osteoporosis, and mental illness. Undernutrition was strongly associated, both in the review of published work and in new analyses, with shorter adult height, less schooling, reduced economic productivity, and—for women—lower offspring birthweight. Associations with adult disease indicators were not so clear-cut. Increased size at birth and in childhood were positively associated with adult body-mass index and to a lesser extent with blood pressure values, but not with blood glucose concentrations. In our new analyses and in published work, lower birthweight and undernutrition in childhood were risk factors for high glucose concentrations, blood pressure, and harmful lipid profiles once adult body-mass index and height were adjusted for, suggesting that rapid postnatal weight gain—especially after infancy—is linked to these conditions. The review of published works indicates that there is insufficient information about long-term changes in immune function, blood lipids, or osteoporosis indicators. Birthweight is positively associated with lung function and with the incidence of some cancers, and undernutrition could be associated with mental illness. We noted that height-for-age at 2 years was the best predictor of human capital and that undernutrition is associated with lower human capital. We conclude that damage suffered in early life leads to permanent impairment, and might also affect future generations. Its prevention will probably bring about important health, educational, and economic benefits. Chronic diseases are especially common in undernourished children who experience rapid weight gain after infancy.
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              Women's groups practising participatory learning and action to improve maternal and newborn health in low-resource settings: a systematic review and meta-analysis

              Maternal and neonatal mortality rates remain high in many low-income and middle-income countries. Different approaches for the improvement of birth outcomes have been used in community-based interventions, with heterogeneous effects on survival. We assessed the effects of women's groups practising participatory learning and action, compared with usual care, on birth outcomes in low-resource settings. We did a systematic review and meta-analysis of randomised controlled trials undertaken in Bangladesh, India, Malawi, and Nepal in which the effects of women's groups practising participatory learning and action were assessed to identify population-level predictors of effect on maternal mortality, neonatal mortality, and stillbirths. We also reviewed the cost-effectiveness of the women's group intervention and estimated its potential effect at scale in Countdown countries. Seven trials (119,428 births) met the inclusion criteria. Meta-analyses of all trials showed that exposure to women's groups was associated with a 37% reduction in maternal mortality (odds ratio 0.63, 95% CI 0.32-0.94), a 23% reduction in neonatal mortality (0.77, 0.65-0.90), and a 9% non-significant reduction in stillbirths (0.91, 0.79-1.03), with high heterogeneity for maternal (I(2)=58.8%, p=0.024) and neonatal results (I(2)=64.7%, p=0.009). In the meta-regression analyses, the proportion of pregnant women in groups was linearly associated with reduction in both maternal and neonatal mortality (p=0.026 and p=0.011, respectively). A subgroup analysis of the four studies in which at least 30% of pregnant women participated in groups showed a 55% reduction in maternal mortality (0.45, 0.17-0.73) and a 33% reduction in neonatal mortality (0.67, 0.59-0.74). The intervention was cost effective by WHO standards and could save an estimated 283,000 newborn infants and 41,100 mothers per year if implemented in rural areas of 74 Countdown countries. With the participation of at least a third of pregnant women and adequate population coverage, women's groups practising participatory learning and action are a cost-effective strategy to improve maternal and neonatal survival in low-resource settings. Wellcome Trust, Ammalife, and National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care for Birmingham and the Black Country programme. Copyright © 2013 Elsevier Ltd. All rights reserved.
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                Author and article information

                Contributors
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: Project administrationRole: SoftwareRole: SupervisionRole: ValidationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: Project administrationRole: SupervisionRole: Writing – review & editing
                Role: Data curationRole: InvestigationRole: MethodologyRole: SupervisionRole: Writing – review & editing
                Role: InvestigationRole: MethodologyRole: SupervisionRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: MethodologyRole: Project administrationRole: SoftwareRole: SupervisionRole: ValidationRole: Writing – review & editing
                Role: Data curationRole: MethodologyRole: Project administrationRole: SoftwareRole: SupervisionRole: Writing – review & editing
                Role: Data curationRole: MethodologyRole: Project administrationRole: SoftwareRole: SupervisionRole: ValidationRole: Writing – review & editing
                Role: MethodologyRole: Project administrationRole: SupervisionRole: ValidationRole: Writing – review & editing
                Role: InvestigationRole: MethodologyRole: Supervision
                Role: Project administrationRole: SupervisionRole: Writing – review & editing
                Role: Project administrationRole: SupervisionRole: Writing – review & editing
                Role: Formal analysisRole: MethodologyRole: Writing – review & editing
                Role: MethodologyRole: Project administrationRole: SupervisionRole: Writing – review & editing
                Role: MethodologyRole: Project administrationRole: SupervisionRole: Writing – review & editing
                Role: InvestigationRole: MethodologyRole: SupervisionRole: Writing – review & editing
                Role: InvestigationRole: MethodologyRole: SupervisionRole: Writing – review & editing
                Role: MethodologyRole: Writing – review & editing
                Role: MethodologyRole: SupervisionRole: Writing – review & editing
                Role: MethodologyRole: Project administrationRole: SupervisionRole: Writing – review & editing
                Role: MethodologyRole: SupervisionRole: Writing – review & editing
                Role: MethodologyRole: SupervisionRole: Writing – review & editing
                Role: Project administrationRole: SupervisionRole: Writing – review & editing
                Role: InvestigationRole: SupervisionRole: Writing – review & editing
                Role: InvestigationRole: SupervisionRole: Writing – review & editing
                Role: SupervisionRole: Writing – review & editing
                Role: ConceptualizationRole: Project administrationRole: SupervisionRole: Writing – review & editing
                Role: ConceptualizationRole: SupervisionRole: Writing – review & editing
                Role: ConceptualizationRole: Project administrationRole: SupervisionRole: Writing – review & editing
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                9 May 2018
                2018
                : 13
                : 5
                : e0194064
                Affiliations
                [1 ] Institute for Global Health, University College London, London, United Kingdom
                [2 ] Mother and Infant Research Activities (MIRA), Kathmandu, Nepal
                [3 ] MRC Clinical Trials Unit, University College London, London, United Kingdom
                [4 ] UN World Food Programme, Rome, Italy
                [5 ] Save the Children UK, London, United Kingdom
                TNO, NETHERLANDS
                Author notes

                Competing Interests: The authors have declared that no competing interests exist.

                [¤a]

                Current address: London School of Hygiene and Tropical Medicine, London, United Kingdom

                [¤b]

                Current address: Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden

                [¤c]

                Current address: Friedman School of Nutrition Science and Policy, Tufts University, Boston, MA, United States of America

                [¤d]

                Current address: World Health Organisation, Geneva, Switzerland

                Author information
                http://orcid.org/0000-0002-1735-3684
                Article
                PONE-D-17-29560
                10.1371/journal.pone.0194064
                5942768
                29742136
                a0e0a203-d5a4-479f-a460-4e21ca5bad2a
                © 2018 Saville et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 10 August 2017
                : 20 February 2018
                Page count
                Figures: 2, Tables: 7, Pages: 29
                Funding
                Funded by: funder-id http://dx.doi.org/10.13039/501100000278, Department for International Development;
                Award ID: PO 5675
                Award Recipient :
                Funded by: funder-id http://dx.doi.org/10.13039/501100000269, Economic and Social Research Council;
                Award ID: ES/I033572/1
                Award Recipient :
                Funded by: funder-id http://dx.doi.org/10.13039/501100000269, Economic and Social Research Council;
                Award ID: ES/I033572/1
                Award Recipient :
                Funded by: funder-id http://dx.doi.org/10.13039/100004440, Wellcome Trust;
                Award ID: 085417MA/Z/08/Z
                Award Recipient :
                Funded by: funder-id http://dx.doi.org/10.13039/100004440, Wellcome Trust;
                Award ID: 085417MA/Z/08/Z
                Award Recipient :
                Funded by: funder-id http://dx.doi.org/10.13039/501100000265, Medical Research Council;
                Award ID: MR/K007270/1
                Award Recipient :
                Funded by: funder-id http://dx.doi.org/10.13039/100004440, Wellcome Trust;
                Award ID: 091561/Z/10/Z
                Award Recipient :
                Funded by: CHRAT PhD studentship
                Award Recipient :
                Funded by: CHRAT PhD studentship
                Award Recipient :
                Primary funder: UKaid from Department for International Development South Asia Research Hub. Grant number: PO 5675 ( https://www.gov.uk/dfid-research-outputs/protocol-of-the-low-birth-weight-south-asia-trial-lbwsat). Partial funding of UCL team members: i) Economic and Social Research Council and the Department for International Development. Grant number: ES/I033572/1 (NMS and JM) http://www.researchcatalogue.esrc.ac.uk/grants/RES-167-25-0682/outputs/read/3a868b75-18cc-47c6-ad89-88f3b8b2ab66; ii) Wellcome Trust Strategic Award for the Population Science of Maternal and Newborn Survival. Grant number: 085417MA/Z/08/Z (NMS and AMC) https://wellcome.ac.uk/funding/managing-grant/grants-awarded; iii) Medical Research Council Grant number:MR/K007270/1 (NMS) http://gtr.rcuk.ac.uk/projects?ref=MR%2FK007270%2F1; iv) Wellcome Trust Senior Fellowship number 091561/Z/10/Z (DO) https://wellcome.ac.uk/what-we-do/directories/senior-research-fellowships-clinical-science-people-funded; and v) two UCL Institute of Child Health Child Health Research Appeal Trust (CHRAT) PhD studentships (HHF and LG) https://www.ucl.ac.uk/ich/about-us/cio/cio-overview. Role of the primary funding source: The UK Department for International Development (DfID) produced a Terms of Reference for the tender for the trial, stipulating broadly the four study arms and design. They reviewed the protocol and an early draft of this manuscript prior to submission. Otherwise, the funder had no role in the detailed study design, data collection, management, analysis, interpretation, or writing up. NMS had full access to all the data in the study and had final responsibility for the decision to submit for publication.
                Categories
                Research Article
                Medicine and Health Sciences
                Women's Health
                Maternal Health
                Pregnancy
                Medicine and Health Sciences
                Women's Health
                Obstetrics and Gynecology
                Pregnancy
                Biology and Life Sciences
                Nutrition
                Medicine and Health Sciences
                Nutrition
                Biology and Life Sciences
                Physiology
                Physiological Parameters
                Body Weight
                Birth Weight
                Medicine and Health Sciences
                Physiology
                Physiological Parameters
                Body Weight
                Birth Weight
                People and Places
                Population Groupings
                Age Groups
                Children
                Infants
                People and Places
                Population Groupings
                Families
                Children
                Infants
                Medicine and Health Sciences
                Women's Health
                Maternal Health
                Birth
                Labor and Delivery
                Medicine and Health Sciences
                Women's Health
                Obstetrics and Gynecology
                Birth
                Labor and Delivery
                Biology and Life Sciences
                Anatomy
                Anthropometry
                Medicine and Health Sciences
                Anatomy
                Anthropometry
                Biology and Life Sciences
                Behavior
                Medicine and Health Sciences
                Health Care
                Health Statistics
                Morbidity
                Custom metadata
                All data files are available from the https://reshare.ukdataservice.ac.uk database. Please find the DOI for the LBWSAT trial dataset DOI: 10.5255/UKDA-SN-853120< https://dx.doi.org/10.5255/UKDA-SN-853120> This is the Low Birth weight South Asia Trial dataset as analysed in the primary analyses of the study presented in the paper. These data are restricted due to ethical concerns and are accessible to scientists seeking to undertake novel analyses which are non-overlapping with others who already have access to or who are owners of the data. At the time of taking consent respondents agreed to allow others to use their non-personally identifiable data for other research so secondary analyses are available. In order to gain access please fill in the data sharing agreement form available in this data depository and email it to Naomi Saville at n.saville@ 123456ucl.ac.uk . On receipt of a request, the data sharing committee comprising members of UCL Institute for Global Health and Dr DS Manandhar, executive director of Mother and Infant Research Activities (MIRA) in Nepal will review the request and grant access to the dataset as appropriate. The data are not for commercial use.

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