Effect of breastfeeding education and support intervention (BFESI) versus routine care on timely initiation and exclusive breastfeeding in Southwest Ethiopia: study protocol for a cluster randomized controlled trial

Misra Abdulahi, Atle Fretheim, Jeanette H Magnus, Misra Abdulahi, Atle Fretheim, Jeanette H Magnus

Abstract

Background: Infant mortality rates are still high in Ethiopia. Breastfeeding is regarded as the simplest and least expensive strategy for reduction of infant mortality rates. Community-based educational and support interventions provided prenatally and postnatally are effective in increasing breastfeeding rates. However, such interventions are not widely implemented in Ethiopia. This study aims to assess the effect of breastfeeding education and support on timely initiation and duration of exclusive breastfeeding.

Methods: A cluster-randomized controlled trial at the community level will be conducted to compare the effect of breastfeeding education and support versus routine care. The intervention will be provided by Women Development Army leaders who are already in the country's health system using a 40-h WHO breastfeeding counseling course, "Infant and Young Child Feeding Counseling: an integrated course" and the "Training of Trainers Manual for Counseling on Maternal, Infant and Young Child Nutrition" in the local language. Culturally appropriate operational packages of information will be developed for them. Using preset criteria at least 432 pregnant women in their third trimester will be recruited from 36 zones. Visits in the intervention arm include two prenatal visits and 8 postnatal visits. Supervisory visits will be conducted monthly to each intervention zone. Data will be entered into Epi-data version 3.1 and analyzed using STATA version 13.0. All analysis will be done by intention to treat analysis. We will fit mixed-effects linear regression models for the continuous outcomes and mixed-effects linear probability models for the binary outcomes with study zone as random intercept to estimate study arm difference (intervention vs. routine education) adjusted for baseline value of the outcome and additional relevant covariates. The protocol was developed in collaboration with the Jimma Zone and Mana district Health office. Ethical clearance was obtained from the Institutional Review Board of University of Oslo and Jimma University. This study is partly funded by NORAD's NORHED programme.

Discussion: We expect that the trial will generate findings that can inform breastfeeding policies and practices in Ethiopia.

Trial registration: ClinicalTrials.gov NCT 03030651 January 25, 2017 version 3 dated 16 July 2018.

Trial registration: ClinicalTrials.gov NCT03030651.

Keywords: Community-based intervention; Early initiation of breastfeeding; Exclusive breastfeeding; Peer education; Peer support.

Conflict of interest statement

Ethics approval and consent to participate

Ethical clearance was obtained from the Institutional Review Board of University of Oslo (ref 2016/1726 REC South East, Section D) as well as from Jimma University (RPGC/381/2016) and the Oromia region (ORH/AH31711/1–8/2341). The purpose of the trial was explained in a formal letter and verbally to district administrative and health officials. Approval to include the selected zones in the trial will be sought from kebele authorities. After identification of all pregnant women in each cluster, they were invited to a meeting where nature and purpose of the trial was explained. Then data collectors explained the detailed procedures on the information sheet from inclusion criteria to the last follow-up. The women will be given chance to ask questions. Pregnant women, who fulfill eligibility criteria, agree to participate in the trial and agree to be visited by data collectors will be requested to sign a written informed consent. Women who are unable to read and/or write give a thumbprint. If the woman is less than 18 years old then consent will be sought from her husband or guardian. Irrespective of their participation in data collection, all women in intervention clusters will benefit from counselling sessions on EBF if they wished. During the course of the trial, women while pregnant or after giving birth and infants reporting to be ill in both study groups will be referred to health facilities.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow of participants
Fig. 2
Fig. 2
Flow diagram of structures in the Oromia region and the jimma zone
Fig. 3
Fig. 3
Hierarchy of reporting

References

    1. WHO. Global strategy for infant and young child feeding. . 2003.
    1. Bhandari N, Bahl R, Mazumdar S, Martines J, Black RE, Bhan MK. Effect of community-based promotion of exclusive breastfeeding on diarrhoeal illness and growth: a cluster randomised controlled trial. Lancet (London, England). 2003;361(9367):1418–1423. doi: 10.1016/S0140-6736(03)13134-0.
    1. Brown KHBR, Lopez de Romana G, Creed de Kanashiro H. Infant-feeding practices and their relationship with diarrheal and other diseases in Huascar (Lima), Peru. Pediatrics. 1989;83(1):31–40.
    1. Heinig MJ, Dewey KG. Health advantages of breast feeding for infants: a critical review. Nutr Res Rev. 1996;9(1):89–110. doi: 10.1079/NRR19960007.
    1. Popkin BM, Adair L, Akin JS, Black R, Briscoe J, Flieger W. Breast-feeding and diarrheal morbidity. Pediatrics. 1990;86(6):874–882.
    1. Victora CG, Fuchs SC, Flores JA, Fonseca W, Kirkwood B. Risk factors for pneumonia among children in a Brazilian metropolitan area. Pediatrics. 1994;93(6 Pt 1):977–985.
    1. Horta BL, Bahl, R., Martines, J. C., & Victora, C. G. Evidence on the long-term effects of breastfeeding – Systematic reviews and meta-analyses. . 2007.
    1. Arenz S, Ruckerl R, Koletzko B, von Kries R. Breast-feeding and childhood obesity – a systematic review. Int J Obes. 2004;28:1247–1256. doi: 10.1038/sj.ijo.0802758.
    1. Grummer-Strawn LM, Mei Z. Does breastfeeding protect against pediatric overweight? Analysis of longitudinal data from the Centers for Disease Control and Prevention pediatric nutrition surveillance system. Pediatrics. 2004;113:e81–ee6. doi: 10.1542/peds.113.2.e81.
    1. Harder T, Bergmann R, Kallischnigg G, Plagemann A. Duration of breastfeeding and risk of overweight: a meta-analysis. Am J Epidemiol. 2005;162:397–403. doi: 10.1093/aje/kwi222.
    1. Li R, Fein SB, Grummer-Strawn LM. Association of breastfeeding intensity. and bottle-emptying behaviors at early infancy with infants’ risk for excess weight. at late infancy. Pediatrics. 2008;122((Suppl. 2)):S77–S84. doi: 10.1542/peds.2008-1315j.
    1. Owen CG, Martin RM, Whincup PH, Smith GD, Cook DG. Effect of infant feeding on the risk of obesity across the life course. A quantitative review of published evidence Pediatrics. 2005;115:1367–1377.
    1. Black RE, Allen LH, Bhutta ZA, Caulfield LE, de Onis M, Ezzati M, et al. Maternal and child undernutrition: global and regional exposures and health consequences. Lancet (London, England) 2008;371(9608):243–260. doi: 10.1016/S0140-6736(07)61690-0.
    1. Sankar MJSB, Chowdhury R, Bhandari N, Taneja S, Martines J, Bahl R. Optimal breastfeeding practices and infant and child mortality: a systematic review and meta-analysis. Acta Paediatr. 2015;104:3–13. doi: 10.1111/apa.13147.
    1. WHO. Infant and Young Child feeding . Model chapter for textbooks for medical students and allied heath professionals. Geneva: World Health Organization; 2009.
    1. UNICEF . State of the world's children 2013: children with disabilities. New York: UNICEF; 2013.
    1. ICF Ca . Ethiopia demographic and health survey: key indicators report. Ethiopia, and Rockville, Maryland, USA. CSA and ICF: Addis Ababa; 2016.
    1. World Health Organization U. Implementation guidance: protection, promotion and support of breastfeeding in facilities providing maternity and newborn services - the revised Baby-friendly Hospital Initiative. In. Geneva: World Health Organization. 2018.
    1. Braun ML, Giugliani ER, Soares ME, Giugliani C, de Oliveira AP, Danelon CM. Evaluation of the impact of the baby-friendly hospital initiative on rates of breastfeeding. Am J Public Health. 2003;93(8):1277–1279. doi: 10.2105/AJPH.93.8.1277.
    1. Martens PJ. What do Kramer's baby-friendly hospital initiative PROBIT studies tell us? A review of a decade of research. Journal of human lactation : official journal of International Lactation Consultant Association. 2012;28(3):335–342. doi: 10.1177/0890334412438264.
    1. Merten S, Dratva J, Ackermann-Liebrich U. Do baby-friendly hospitals influence breastfeeding duration on a national level? Pediatrics. 2005;116(5):e702–e708. doi: 10.1542/peds.2005-0537.
    1. Perez-Escamilla R. Evidence based breast-feeding promotion: the baby-friendly hospital initiative. J Nutr. 2007;137(2):484–487. doi: 10.1093/jn/137.2.484.
    1. Haider R, Ashworth A, Kabir I, Huttly SR. Effect of community-based peer counsellors on exclusive breastfeeding practices in Dhaka, Bangladesh: a randomised controlled trial. [see commments] Lancet (London, England) 2000;356(9242):1643–1647. doi: 10.1016/S0140-6736(00)03159-7.
    1. Hodnett E. Efficacy of home-based peer counseling to promote exclusive breast-feeding: a randomized controlled trial. J Pediatr. 1999;135(5):649–650.
    1. Kistin N, Abramson R, Dublin P. Effect of peer counselors on breastfeeding initiation, exclusivity, and duration among low-income urban women. Journal of human lactation : official journal of International Lactation Consultant Association. 1994;10(1):11–15. doi: 10.1177/089033449401000121.
    1. McInnes RJ, Stone DH. The process of implementing a community-based peer breast-feeding support programme: the Glasgow experience. Midwifery. 2001;17(1):65–73. doi: 10.1054/midw.2000.0236.
    1. Morrow AL, Guerrero ML, Shults J, Calva JJ, Lutter C, Bravo J, et al. Efficacy of home-based peer counselling to promote exclusive breastfeeding: a randomised controlled trial. Lancet (London, England). 1999;353(9160):1226–1231. doi: 10.1016/S0140-6736(98)08037-4.
    1. Renfrew MJ, McCormick FM, Wade A, Quinn B, Dowswell T. Support for healthy breastfeeding mothers with healthy term babies. The Cochrane database of systematic reviews. 2012(5):Cd001141.
    1. Tylleskar T, Jackson D, Meda N, Engebretsen IM, Chopra M, Diallo AH, et al. Exclusive breastfeeding promotion by peer counsellors in sub-Saharan Africa (PROMISE-EBF): a cluster-randomised trial. Lancet (London, England). 2011;378(9789):420–427. doi: 10.1016/S0140-6736(11)60738-1.
    1. Asma Misbah Qureshi OMO, Sadiq UA, Kabiru S. Using community volunteers to promote exclusive breastfeeding in Sokoto state, Nigeria. Pan African Medical Journal. 2011;10(8).
    1. Bridget A. Aidam RPr-E, and Anna Lartey. Lactation counseling increases exclusive breast-feeding rates in Ghana. J Nutr. 2005;135:1691–1695. doi: 10.1093/jn/135.7.1691.
    1. Barwick M. BR Z. An Examination of Exclusive Breastfeeding Implementation in Ethiopia and Mali: Factors Influencing Change. . 2015.
    1. Kim SSAD, Kennedy A, Tesfaye R, Tadesse AW, Abrha TH, et al. Assessing implementation fidelity of a community-based infant and young child feeding intervention in Ethiopia identifies delivery challenges that limit reach to communities: a mixed-method process evaluation study. BMC Public Health. 2015;15:316. doi: 10.1186/s12889-015-1650-4.
    1. vision W. Health and Nutrition. Ethiopia’s community health workers. December. 2015:28.
    1. Belay SHJ. Effect of prenatal education on breastfeeding initiation and exclusive breast feeding rate in selected health institutions of Hawassa city, the capital of SNNPR. Ethiopia: East African Journal of Public Health; 2013.
    1. Health FDRoEMo. POLICY AND PRACTICE INFORMATION FOR ACTION. Quarterly Health Bulletin April 2014;6(1).
    1. USAID. The Female "Army" Leading Ethiopia's Health Revolution. 2012.
    1. MOH F. Policy and practice information for action. . Quarterly Health Bulletin. April 2014;6(1).
    1. FMOH. Health Extension Program in Ethiopia Profile. Federal Ministry of Health of the Federal Democratic Republic of Ethiopia. . 2007.
    1. FDRE. National report on the implementation of the Beijing declaration and platform for action (1995) and the outcome of the 23rd special session of the united nations general assembly (2000).
    1. Teklehaimanot HD T. Human resource development for a community-based health extension program: a case study from Ethiopia.
    1. UNICEF. Survival and Health. The Health Extension Program. Media &External Relations Section.
    1. KA CJ, Langer A. Health Extension Workers in Ethiopi: Delivering community-based antenatal and postnatal care. 2014.
    1. USAID. Health system 20/20. Health Extension Program: An Innovative Solution to Public Health Challenges of Ethiopia A Case Study. . 2012.
    1. EFMOH. Health Sector Development Programme-IV. . 2011.
    1. EFMOH. Blended Learning Module for the Health Extension Programme. Postnatal Care.
    1. Bilal NJHCH, Zhao F, Soucat A, Lemiere C. Health Extension Workers in Ethiopia: Improved Access and Coverage for the Rural Poor Chapter. 4:433–43.
    1. Sample Size Calculator. .
    1. PROMISE-EBF a multicentre community-based cluster-randomised behavioural-intervention trial in sub-Saharan Africa, webappendix.
    1. USAID I. Training of trainers manual for counseling on maternal, infant, and young child nutrition. 2011.
    1. WHO. Infant and young child feeding counseling an integrated course.2006.
    1. WHO/UNICEF. Breastfeeding Counselling: A Training Course.
    1. WHO. The WHO Child Growth Standards. 2006.
    1. Physical status WHO. The use and interpretation of anthropometry. In WHO technical report series 854. Geneva. 1995:452.
    1. RD DLMA. The Iowa infant feeding attitude scale: analysis of reliability and validity. J Appl Soc Psychol. 1999;29:2362–2380. doi: 10.1111/j.1559-1816.1999.tb00115.x.
    1. Ismail TAT, Sulaiman Z. Reliability and validity of a Malay-version questionnaire assessing knowledge of breastfeeding. Malaysian J Med Sci Jul-Sep. 2010;17(3):32–39.
    1. Sittlington J, Stewart-Knox B, Wright M, Bradbury I, Scott JA. Infant-feeding attitudes of expectant mothers in Northern Ireland. Health Educ Res. 2007;22(4):561–570. doi: 10.1093/her/cyl113.
    1. Dungy CI, McInnes RJ, Tappin DM, Wallis AB, Oprescu F. Infant feeding attitudes and knowledge among socioeconomically disadvantaged women in Glasgow. Matern Child Health J. 2008;12(3):313–322. doi: 10.1007/s10995-007-0253-9.
    1. NKaJ M. Reliability and validity of the Japanese version of the Iowa infant feeding attitude scale: a longitudinal study. J Hum Lact. 2014;30(3):346–352. doi: 10.1177/0890334414534321.
    1. Wallis ABBA, Chereches R, Oprescu F, irlincan ES. David I.,, Dˆırle I. A. DCI. Reliability and validity of the Romanian version of a scale to measure infant feeding attitudes and knowledge. Acta Paediatr. 2008;97:1194–1199. doi: 10.1111/j.1651-2227.2008.00914.x.
    1. Ho YJMJM. A Chinese version of Iowa infant feeding attitude scale: reliability and validity assessment. Int J Nurs Stud. 2011;48:475–478. doi: 10.1016/j.ijnurstu.2010.09.001.
    1. Beaton D, Bombardier C, Guillemin F, Ferraz M. Recommendations for the cross-cultural adaptation of health status measures. 2002. B.
    1. Skperber AD, DeVellis RF, Boehlecke B. Cross-cultural translation: methodology and validation. J Cross-Cult Psychol. 1994;25(4):501–524. doi: 10.1177/0022022194254006.
    1. JM. W. Econometric Analysis of Cross Section and Panel Data. Cambridge, Massachussetts, USA. . 2002.
    1. HJ. BS. Effect of prenatal education on breastfeeding initiation and exclusive breast feeding rate in selected health institutions of Hawassa city, the capital of SNNPR . East African journal of public health. 2013. Ethiopia.
    1. Kronborg H, MV JO, Iversen L, Harder I. Effect of early postnatal breastfeeding support: a cluster-randomized community based trial. Acta Paediatr. 2007;96:1064–1070. doi: 10.1111/j.1651-2227.2007.00341.x.
    1. Sandy JM. EA, and Erline Ramirez, . Effects of a prenatal intervention on breastfeeding initiation rates in a Latina immigrant sample. J Hum Lact. 2009;25(4):404–411. doi: 10.1177/0890334409337308.
    1. Shahla Meedya KF, Ashley Kable. Factors that positively influence breastfeeding duration to 6 months: a literature review. Women and Birth 2010;23:135—45.
    1. Malterud K. Systematic text condensation: a strategy for qualitative analysis. Scandinavian Journal of Public Health. 2012;40(8):795–805. doi: 10.1177/1403494812465030.

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