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BMJ Open Is Committed to Open Peer Review. As Part of This Commitment We Make the Peer Review History of Every Article We Publish Publicly Available BMJ Open: first published as 10.1136/bmjopen-2020-038393 on 24 March 2021. Downloaded from BMJ Open is committed to open peer review. As part of this commitment we make the peer review history of every article we publish publicly available. When an article is published we post the peer reviewers’ comments and the authors’ responses online. We also post the versions of the paper that were used during peer review. These are the versions that the peer review comments apply to. The versions of the paper that follow are the versions that were submitted during the peer review process. They are not the versions of record or the final published versions. They should not be cited or distributed as the published version of this manuscript. BMJ Open is an open access journal and the full, final, typeset and author-corrected version of record of the manuscript is available on our site with no access controls, subscription charges or pay-per-view fees (http://bmjopen.bmj.com). If you have any questions on BMJ Open’s open peer review process please email [email protected] http://bmjopen.bmj.com/ on September 29, 2021 by guest. Protected copyright. BMJ Open BMJ Open: first published as 10.1136/bmjopen-2020-038393 on 24 March 2021. Downloaded from THE EFFECT OF BALANCED ENERGY-PROTEIN SUPPLEMENTATION DURING PREGNANCY AND LACTATION ON BIRTH OUTCOMES AND INFANT GROWTH IN RURAL BURKINA FASO : STUDY PROTOCOL FOR A RANDOMIZED For peerCONTROLLED review TRIAL only Journal: BMJ Open Manuscript ID bmjopen-2020-038393 Article Type: Protocol Date Submitted by the 11-Mar-2020 Author: Complete List of Authors: Vanslambrouck, Katrien; University of Ghent, Food Technology, Safety and Health, Faculty of Bioscience Engineering de Kok, Brenda; Ghent University, Department of Food Technology, Safety and Health, Faculty of Bioscience Engineering Toe, Laeticia Celine; Ghent University, Department of Food Technology, Safety and Health, Faculty of Bioscience Engineering; Institut de Recherche en Sciences de la Sante De Cock, Nathalie; Ghent University, Department of Food Technology, Safety and Health, Faculty of Bioscience Engineering Ouedraogo, Moctar; AfricSanté http://bmjopen.bmj.com/ Ganaba, Rasmané; AfricSanté Lachat, Carl; Ghent University, Department of Food Technology, Safety and Health, Faculty of Bioscience Engineering Huybregts, Lieven; IFPRI, PHN division Kolsteren, Patrick; Ghent University, Department of Food Technology, Safety and Health, Faculty of Bioscience Engineering Nutrition < TROPICAL MEDICINE, Community child health < Keywords: PAEDIATRICS, Protocols & guidelines < HEALTH SERVICES on September 29, 2021 by guest. Protected copyright. ADMINISTRATION & MANAGEMENT For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 28 BMJ Open 1 2 3 4 BMJ Open: first published as 10.1136/bmjopen-2020-038393 on 24 March 2021. 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Where the Submitting Author wishes to make the Work available on an Open Access basis (and 21 intends to pay the relevant APC), the terms of reuse of such Open Access shall be governed by a Creative 22 Commons licence – details of these licences and which Creative Commons licence will apply to this Work are set 23 out in our licence referred to above. 24 25 Other than as permitted in any relevant BMJ Author’s Self Archiving Policies, I confirm this Work has not been 26 accepted for publication elsewhere, is not being considered for publication elsewhere and does not duplicate 27 material already published. I confirm all authors consent to publication of this Work and authorise the granting 28 of this licence. 29 30 31 32 33 34 35 36 37 http://bmjopen.bmj.com/ 38 39 40 41 42 43 44 45 on September 29, 2021 by guest. Protected copyright. 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 28 1 2 3 BMJ Open: first published as 10.1136/bmjopen-2020-038393 on 24 March 2021. Downloaded from 4 [Title Page File] 5 6 7 Title: 8 THE EFFECT OF BALANCED ENERGY-PROTEIN SUPPLEMENTATION DURING PREGNANCY AND 9 10 LACTATION ON BIRTH OUTCOMES AND INFANT GROWTH IN RURAL BURKINA FASO : STUDY PROTOCOL 11 12 FOR A RANDOMIZED CONTROLLED TRIAL 13 14 15 16 Authors: 17 Vanslambrouck Katrien a, de Kok Brenda a, Toe Laeticia Celine a c, De Cock Nathalie a, Ouedraogo Moctar d Ganaba 18 For peer review only 19 Rasmané d, Lachat Carl a, Huybregts Lieven b, Kolsteren Patrick a 20 21 22 23 Authors institutional affiliations: 24 a 25 Department of Food Technology, Safety and Health, Faculty of Bioscience Engineering, Ghent 26 University, Ghent, Belgium 27 28 b Poverty, Health and Nutrition Division, International Food Policy Research Institute (IFPRI), 1201 I 29 30 Street NW, Washington, DC 20006, USA 31 c Institut de Recherche en Sciences de la Santé (IRSS), Bobo-Dioulasso, Burkina Faso 32 33 d Africsanté, Bobo-Dioulasso, Burkina Faso 34 35 36 Word count : http://bmjopen.bmj.com/ 37 38 3.763 words 39 40 41 Correspondence : 42 [email protected] 43 44 45 Other email addresses : on September 29, 2021 by guest. Protected copyright. 46 [email protected] - [email protected] - [email protected] 47 48 [email protected] – [email protected] - [email protected] – [email protected] - 49 50 [email protected] 51 52 53 54 55 56 57 58 59 60 1 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 28 BMJ Open 1 2 3 [Main Text File] 4 BMJ Open: first published as 10.1136/bmjopen-2020-038393 on 24 March 2021. Downloaded from 5 6 Abstract 7 8 Introduction: 9 10 Adequate nutrition during pregnancy is crucial to both mother and child. Maternal malnutrition can 11 be the cause of stillbirth or lead to poor birth outcomes such as preterm delivery and small-for- 12 13 gestational-age new-borns. There is a possible positive effect of providing pregnant women a balanced 14 15 energy and protein (BEP) food supplement but more evidence is needed. The MISAME III project is 16 aiming to improve birth outcomes and infant growth by testing a BEP supplement during pregnancy 17 18 and lactation in rural ForBurkina Faso. peer This paper review presents the protocol. only 19 20 Methods and analysis: 21 22 MISAME III is an individually randomized efficacy trial implemented in six rural health center 23 catchments areas in the district of Houndé, Burkina Faso. Eligible pregnant women living in these areas 24 25 and in the reproductive age range (between 15-40 years old) will be enrolled. Women will be randomly 26 27 assigned to one of the four study groups: (i) prenatal intervention only, (ii) postnatal intervention only, 28 (iii) prenatal and postnatal intervention or (iv) no prenatal or postnatal intervention. The intervention 29 30 group will receive the BEP supplement and iron/folic acid (IFA) tablets while the control group will only 31 32 receive the IFA tablets following the national health protocol. Consumption will be supervised by 33 trained village women on a daily basis through home visits. The primary outcomes are small-for- 34 35 gestational age at birth and length-for-age z-score at six months of age. Secondary outcomes will be 36 37 measured at birth and during the first six months of the infants’ life. http://bmjopen.bmj.com/ 38 Ethics and dissemination: 39 40 MISAME III has been reviewed and approved by the University Hospital of Ghent University and the 41 42 ethics committee of Centre Muraz, Burkina Faso. Informed consent will be obtained from participants. 43 44 Results of the various studies will be published in relevant journals and shared with other researchers on September 29, 2021 by guest. Protected copyright. 45 and public health institutions. 46 47 Trial registration number on Clinical Trial: NCT03533712. 48 49 Protocol v1 50 51 6/03/2020 52 53 54 55 56 57 58 59 60 2 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 28 1 2 3 4 BMJ Open: first published as 10.1136/bmjopen-2020-038393 on 24 March 2021. Downloaded from 5 6 7 Strengths and limitations of this study 8 - This trial will help to fill in the gap on how to improve birth outcomes in pregnant women in 9 10 lower-and middle-income countries.
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