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      The Shishu Pushti Trial–Extended Peer Counseling for Improving Feeding Practices and Reducing Undernutrition in Children Aged 0-48 Months in Urban Bangladesh: Protocol for a Cluster-Randomized Controlled Trial


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          The aim of this study is to assess if peer counseling of women improves breastfeeding, complementary feeding practices, and child growth, and thus reduces the prevalence of undernutrition in children up to 4 years of age.


          Lack of exclusive breastfeeding and inappropriate complementary feeding are critical factors in reducing child undernutrition, morbidity, and mortality. There are reported trials of peer counseling to improve breastfeeding; however, they did not examine the efficacy of peer counseling to improve complementary feeding or the long-term impacts on child growth and development.


          This study has used a community-based, cluster-randomized controlled trial with a superiority design and 2 parallel treatment arms. It is assessing the impact of peer counseling, starting in late pregnancy up to 1 year after delivery, on child feeding practices, growth, and development with follow-up until 48 months of age. The study site was Mirpur, a densely populated area in Dhaka. Using satellite maps and geographic information system mapping, we constructed 36 clusters with an average population of 5000 people. We recruited pregnant women in the third trimester aged 16-40 years, with no more than 3 living children. Trained peer counselors visited women at home twice before delivery, 4 times in the first month, monthly from 2 to 6 months, and again at 9 and 12 months. Trained research assistants collected anthropometric measurements. The primary outcome will be differences in child stunting and mean length for age at 6, 12, 15, and 18 months. Secondary outcomes will be differences in the percentage of women exclusively breastfeeding in the mean duration of any breastfeeding and in the percentage of children at 6 and 9 months of age who receive solid, semisolid, or soft foods; and the percentage of children consuming foods from 4 or more food groups at 9, 12, 15, and 18 months. We will assess the mean cognitive function scores from the Ages and Stages Questionnaire (9 and 18 months) and Bayley tests (24 and 36 months).


          We identified 65,535 people in mapped residences, from which we defined 36 clusters and randomly allocated them equally to intervention or control groups stratified by cluster socioeconomic status. From July 2011 to May 2013, we identified 1056 pregnant women and 993 births in the intervention group and 994 pregnancies and 890 births in the control group. At 18 months, 692 children remained in the intervention group and 551 in the control group. From January 2015 to February 2017, we conducted the long-term follow-up of the cohort. We have now completed the data collection and processing and have started analyses.


          This study will help fill the evidence gap about the short- and long-term impact of peer counseling on improving infant feeding, preventing childhood undernutrition, and enhancing child cognitive development.

          Trial Registration

          ClinicalTrials.gov NCT01333995; https://clinicaltrials.gov/ct2/show/NCT01333995

          International Registered Report Identifier (IRRID)


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          Most cited references57

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              SPIRIT 2013 statement: defining standard protocol items for clinical trials.

              The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                February 2022
                7 February 2022
                : 11
                : 2
                : e31475
                [1 ] Department of Health Sciences Faculty of Medicine, Health and Human Sciences Macquarie University Macquarie Park Australia
                [2 ] Sydney School of Public Health The University of Sydney Sydney Australia
                [3 ] Nutrition and Clinical Services Division International Centre for Diarrhoeal Disease Research, Bangladesh Dhaka Bangladesh
                [4 ] School of Health Sciences Western Sydney University Campbelltown Australia
                [5 ] Projahnmo Research Foundation Dhaka Bangladesh
                [6 ] Bangladesh Breastfeeding Foundation Institute of Public Health Dhaka Bangladesh
                [7 ] Training and Assistance for Health and Nutrition Foundation Dhaka Bangladesh
                Author notes
                Corresponding Author: Seema Mihrshahi seema.mihrshahi@ 123456mq.edu.au
                Author information
                ©Seema Mihrshahi, Gulshan Ara, Mansura Khanam, Sabrina Rasheed, Kingsley Emwinyore Agho, AKM Iqbal Kabir, S K Roy, Rukhsana Haider, Jena Derakhshani Hamadani, Fahmida Tofail, Ashraful Alam, Michael J Dibley. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 07.02.2022.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 14 July 2021
                : 8 September 2021
                Custom metadata
                This paper was peer reviewed by the National Health and Medical Research Council of Australia, and International Centre for Diarrhoeal Disease Research, Bangladesh. See the Multimedia Appendix for the peer-review report;

                child stunting,prevention,nutrition behavior change,breastfeeding: infant and young child feeding,peer counseling, child development


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