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      Effect of the mHealth-supported Healthy Future programme delivered by community health workers on maternal and child health in rural China: study protocol for a cluster randomised controlled trial

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          Abstract

          Introduction

          Millions of young rural children in China still suffer from poor health and malnutrition, partly due to a lack of knowledge about optimal perinatal and child care among rural mothers and caregivers. Meanwhile, there is an urgent need to improve maternal mental health in rural communities. Comprehensive home visiting programmes delivered by community health workers (CHWs) can bridge the caregiver knowledge gap and improve child health and maternal well-being in low-resource settings, but the effectiveness of this approach is unknown in rural China. Additionally, grandmothers play important roles in child care and family decision-making in rural China, suggesting the importance of engaging multiple caregivers in interventions. The Healthy Future programme seeks to improve child health and maternal well-being by developing a staged-based curriculum that CHWs deliver to mothers and caregivers of young children through home visits with the assistance of a tablet-based mHealth system. This protocol describes the design and evaluation plan for this programme.

          Methods and analysis

          We designed a cluster-randomised controlled trial among 119 rural townships in four nationally designated poverty counties in Southwestern China. We will compare the outcomes between three arms: one standard arm with only primary caregivers participating in the intervention, one encouragement arm engaging primary and secondary caregivers and one control arm with no intervention. Families with pregnant women or infants under 6 months of age are invited to enrol in the 12-month study. Primary outcomes include children’s haemoglobin levels, exclusive breastfeeding rates and dietary diversity in complementary feeding. Secondary outcomes include a combination of health, behavioural and intermediate outcomes.

          Ethics and dissemination

          Ethical approval has been provided by Stanford University, Sichuan University and the University of Nevada, Reno. Trial findings will be disseminated through national and international peer-reviewed publications and conferences.

          Trial registration number

          ISRCTN16800789.

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          Most cited references85

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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.
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            SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

            High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.
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              The Multidimensional Scale of Perceived Social Support

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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2023
                20 January 2023
                : 13
                : 1
                : e065403
                Affiliations
                [1 ] departmentDepartment of Health Policy and Management , Gillings School of Global Public Health, University of North Carolina at Chapel Hill , Chapel Hill, NC, USA
                [2 ] departmentWest China School of Public Health , Sichuan University , Chengdu, China
                [3 ] departmentStanford Center on China’s Economy and Institutions , Stanford University , Stanford, CA, USA
                [4 ] departmentDepartment of Maternal and Child Health , Gillings School of Global Public Health, University of North Carolina at Chapel Hill , Chapel Hill, NC, USA
                [5 ] departmentDepartment of Biostatistics, Epidemiology and Environmental Health , School of Public Health, University of Nevada, Reno , Reno, NV, USA
                [6 ] departmentDepartment of Pediatrics , Stanford University School of Medicine , Stanford, CA, USA
                Author notes
                [Correspondence to ] Dr Huan Zhou; zhouhuan@ 123456scu.edu.cn

                YC and YW are joint first authors.

                Author information
                http://orcid.org/0000-0002-5144-925X
                http://orcid.org/0000-0001-8130-5858
                http://orcid.org/0000-0002-7522-5824
                Article
                bmjopen-2022-065403
                10.1136/bmjopen-2022-065403
                9872510
                36669837
                20451198-8d55-43af-b9e4-f1d895aaac76
                © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 02 June 2022
                : 04 January 2023
                Funding
                Funded by: Enlight Foundation;
                Award ID: N/A
                Categories
                Public Health
                1506
                1724
                Protocol
                Custom metadata
                unlocked

                Medicine
                anaemia,protocols & guidelines,community child health
                Medicine
                anaemia, protocols & guidelines, community child health

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