Effect of a hospital-based maternal counseling guide on exclusive breastfeeding practices in Anambra State, Nigeria: A protocol for a cluster-randomized controlled trial (HOME Trial)

Background: Optimal breastfeeding is so critical that it could save the lives of over 820,000 children under the age of ﬁ ve years each year. For optimal growth, development, and health, the WHO recommends Exclusive Breastfeeding (EBF) in the ﬁ rst six months. To ensure nursing mothers breastfeed their children exclusively, they should also have access to skilled practical help to build mothers’ con ﬁ dence and prevent or resolve breastfeeding problems. Interventions promoting optimal Infant and Young Child Feeding practices could prevent 19% of under-ﬁ ve deaths, and such intervention could improve nursing mothers’ understanding and practice of EBF. Objective : This trial is designed to formulate a hospital-based counseling guide on EBF, implement it, and determine its effect on improving EBF practice in Anambra State, Nigeria.


Background and rationale
Optimal breastfeeding is so critical that it could save the lives of over 820,000 children under the age of fi ve years each year.For optimal growth, development, and health, the WHO recommends exclusive breastfeeding in the fi rst six months, introducing appropriate complementary foods at six months, and continuing breastfeeding for up to two years or more.
However, many infants and children do not receive optimal feeding [1,2] Poor Infant and Young Child Feeding practices have been widely documented, with only 39% of infants exclusively breastfed for six months in developing countries and 25% in Africa [3].In Nigeria, the Federal Ministry of Health (FMOH), in her document "Saving Newborn Lives Maternal and Child Health", reported that Nigeria has one of the lowest EBF rates in the African continent [4].The recent data indicated that the percentage of infants exclusively breastfed to the age of six months is fl uctuating, from 17% in 2003 to 13.1% in 2008 and returned to 17% in 2013, while the proportion of children less than six months who received complementary foods increased from 18% to 35% in 2008 and dropped to 23% in 2013 (Nigerian Demographic & Health Survey [NDHS]) [5].This could be due to inadequate promotion of EBF.
Exclusive Breastfeeding (EBF) during the fi rst six months of life provides suffi cient nutrients for the infant to support good health, growth, and development.EBF and continued breastfeeding up to 11 months can singularly prevent 13% of all annual deaths occurring in infants worldwide [6,7].Exclusive breastfeeding rates have remained stagnant globally since 1990, with only 36% of children aged less than six months exclusively breastfed in 2012 and with only a slight increment in 2016 (i.e.40%) in the same age bracket [8].Although breastfeeding is arguably the single most effective preventive intervention for reducing children's mortality by less than fi ve years [9,10] and is associated with lower risks of diarrhea-and pneumoniarelated infant morbidity and mortality than breastfeeding with the addition of other fl uids and solids in both developed and developing world settings [11,12], its practice is still low.
Numerous factors infl uence the beginning and continuation of breastfeeding.Some of the leading predictors are maternal intention to breastfeed, knowledge defi ciency about the improvement of lactation, and little confi dence in possessing breastfeeding skills [13,14].Even though it is a natural act, breastfeeding is also a learned behavior.Virtually all mothers can breastfeed provided they have accurate information and support within their families and communities and the health care system [15].To ensure nursing mothers breastfeed their children exclusively, they should also have access to skilled practical help from, for example, trained health workers, lay and peer counselors, and certifi ed lactation consultants, who can help to build mothers' confi dence, improve feeding techniques, and prevent or resolve breastfeeding problems [15].Meanwhile, in several studies, maternal breastfeeding self-effi cacy has been strongly associated with EBF duration [16,17].In a systematic review by Ejie, et  for how long it is recommended) and could not differentiate EBF from partial and predominant breastfeeding [18].The study by Ejie, et al. 2020, also revealed that mothers' opinions of EBF and knowledge of the benefi ts of EBF encouraged them to practice EBF despite pressures from their husbands, other family members, and the community at large [18].For these reasons, practical education, counseling, and support programs are considered necessary to promote breastfeeding and prolong the duration of EBF to up to six months of age.Therefore, education and support are the cornerstones supporting the framework of lactation and breastfeeding [19].Implementing health education programs signifi cantly promotes maternal breastfeeding Knowledge, Attitude, and Practice (KAP) [20][21][22].By conducting four 60-min sessions of an educational program, Kang, et al. reported remarkable improvement rates in breastfeeding empowerment and practice [23].
Several studies have reported the positive impact of breastfeeding education during pre-and post-natal periods [24] and, in some cases, placed more emphasis on prenatal education as an initial action [25,26].Comprehensive and culturally appropriate breastfeeding education through counselors (be they doctors, nurses, midwives, lactation consultants, or peer counselors) during the prenatal period, in the hospital during the fi rst week postpartum, and repeated, continual support in the mother's home may be critical for facilitating breastfeeding among mothers, especially those belonging to the low-income groups [27][28][29].Both pre-and post-natal education is vital as the incidence of breastfeeding is affected primarily by prenatal education.In contrast, breastfeeding duration and exclusivity are affected by both prenatal and postpartum management [30,31].Breastfeeding promotion is a global priority with benefi ts for maternal and child health, especially in low-/middle-income countries where its relevance for child survival is undisputed [6].

Therefore, EBF promotion is a vital public health strategy to
Methods: The study is a cluster randomized controlled trial conducted in selected hospitals in Anambra State, Nigeria.Based on inclusion criteria, 12 hospitals that offer comprehensive ante-natal and post-natal clinic services and have a higher population of women assessing care in the ante-and post-natal clinics were selected for the study.Six hospitals each were randomized to either the intervention or the control arm.The intervention hospitals received the formulated hospital-based counseling guide and the hospital's usual care, while the control hospitals received only the hospital's usual care.Statistical analysis will be conducted using Statistical Package for Social Science (SPSS version 25).Descriptive statistics will be used to summarize and present demographic and clinical characteristics.Categorical variables will be expressed as frequencies or percentages and quantitative variables as means, standard deviations, median, and interquartile ranges.An intention-to-treat analysis will be conducted.prevent morbidity and mortality in infants.The promotion of Exclusive Breastfeeding (EBF) has been a cornerstone of public health measures to promote child survival for several decades [6].Thus, a hospital-based maternal counseling guide on EBF may improve EBF practice and ultimately enhance maternalchild health outcomes.

Citation
Few studies have been carried out on interventions to improve EBF practice.For instance, a study in Iran reported that a smartphone-based educational intervention improved EBF practice, but it was limited to only mothers who own and understand the use of smartphones [32].Also, in Nigeria, a study conducted using community volunteers to promote exclusive breastfeeding reported that counseling is a useful strategy for promoting the duration of EBF for six months and recommended additional resources to enable nursing mothers to practice EBF [33]

Research hypotheses
1. Intervention will not produce any difference in knowledge, attitude, and practice of EBF among the study participants.
2. There will be no changes in child weight-for-length z-score (WHZ) and length-for-age z-score (HAZ) after the intervention.
3. There will be no experiences, facilitating, or limiting factors associated with the intervention.

Study objectives
Primary objective: To evaluate the effect of a hospitalbased maternal counseling guide on EBF practices.

Secondary objectives:
1. To assess the knowledge, attitude, and practice of EBF of the study participants before and after the intervention.2. To evaluate the changes in child weight-for-length z-score (WHZ) and length-for-age z-score (HAZ).

Trial design
The HOME Trial is designed as a cluster-randomized, controlled, multicenter parallel trial with two parallel groups and a primary endpoint of six months of EBF practice.The study is in twelve secondary hospitals in Anambra State, southeast Nigeria.A cluster is defi ned as a senatorial zone, and for this study, we have three clusters representing the three senatorial zones in Anambra State.Twenty secondary hospitals that offer comprehensive ante-natal and post-natal clinic services and have a higher population of women accessing care in the ante-and post-natal clinics were selected.Two State governments and eighteen mission-owned hospitals in Anambra State met the selection criteria.After selection, the two State governments-and the eighteen missionowned hospitals were categorized into urban and rural based on their location.After categorization, the two State government-owned yielded one rural and one urban, while the eighteen mission-owned hospitals yielded ten urban and eight rural.Of the ten urban hospitals, fi ve were selected for randomization into the intervention and control arm, and of the eight rural hospitals, fi ve were selected for randomization into the intervention and control arm.In selecting the twelve hospitals, the three clusters were still taken into consideration.Convenient sampling, simple random selection throw of a coin, and simple random selection (using serialized numbering and selecting every odd number) were employed depending on the number of hospitals in the cluster to select the hospital that will participate in the study.The selected rural and urban hospitals were randomly assigned to the intervention or the control arm.Further details of the trial are shown in Table 1 and Appendix 1 (CONSORT checklist) and Appendix 2 which shows the schedule of enrolment, interventions, and assessments for the trial design.

Eligibility criteria
Inclusion criteria: 1. Pregnant women between the ages of 18 to 50 years in their second trimester living in the catchment areas intending to stay for the next year at the time of the study.
2. Pregnant women willing to give informed consent, and able to comply with scheduled visits and other study procedures.
Exclusion criteria: 1. Pregnant women between the ages of 18 to 50 years in their second trimester living in the catchment areas intending to stay for the next year at the time of the study who have given their consent but will not be available during the study.from the formative study revealed that maternal factors were the most signifi cant factor affecting EBF practice hence the need to produce a maternal-targeted intervention in the form of a hospital-based counseling guide on EBF [18,36].

Study setting
The hospital-based counseling guide was based on the WHO/ UNICEF breastfeeding counseling/ lactation management courses [9], the Federal Ministry of Health Antenatal Care Orientation Package [35], and results from the formative study

Assignment of interventions
Sequence generation: Hospitals will be randomly assigned to either a control or intervention group with a 1:1 allocation as per a computer-generated randomization schedule stratifi ed by senatorial zone.
Allocation concealment mechanism: Allocation was not concealed as the randomization was at the cluster level.

Implementation:
The hospitals that gave their approval to participate in the study and fulfi ll the inclusion criteria were categorized and randomized.An independent person who is not part of the research team did the categorization and randomization schedule.

Blinding: Not applicable
Comparison: The hospitals allocated to the control arm (usual/standard care hospital-based nutritional counseling guide) will continue with their usual care.Their study personnel did not receive any training/education on EBF.

Nutrition education process
The nutrition education process will employ the health belief model.The Health Belief Model (HBM) is the most commonly used theory to change health behaviors.According to the model, the messages will achieve optimal behavior change if they successfully target perceived barriers, benefi ts, self-effi cacy, and threats [37].It is based on the belief that the perception an individual has determines their success in taking on that behavior change.Individual perception of health behavior is controlled by modifying variables, cues to action, and self-effi cacy, and successful promotion of health behavior depends on the understanding of the factors that infl uence perception.Women will breastfeed as recommended if they are infl uenced to develop a positive perception of breastfeeding [38].Positive perception and intention toward health behavior will result in self-effi cacy and intention to promote health behavior [38,39].Studies done using the health belief model brought a signifi cant change regarding maternal breastfeeding knowledge and attitude, self-effi cacy, and perceived barriers.
According to a study done in Greece, women in the intervention group had a more positive attitude towards breast-feeding (73.5 % v. 66.1 %), greater knowledge (14.6 % v. 13.1 %) and more breast-feeding self-effi cacy (51.4 % v. 45.6 %) compared to the control group.Furthermore, they had signifi cantly fewer perceived barriers regarding breastfeeding (27.4 % v. 31.0 %) [40].EBF is defi ned as a child receiving only breast milk and no other type of milk, water, or other liquids and solids but allows for vitamins, drops of other medicines, and oral rehydration therapy.Data for both primary and secondary outcomes will be collected using an adapted questionnaire [41] and case report forms.length tests to determine their overall health.The study personnel (nurses/midwives) will follow up with the mothers as the directly responsible parents and encourage them to report any breastfeeding challenge and even call them (nurses/ midwives) if need be.During the follow-ups, the mothers will be asked about their breastfeeding problems and counseled appropriately for the intervention arm.

Participants
To ensure participants adhere to the scheduled visits, we intentionally developed a relationship with them.We collected their phone numbers and home addresses and then we will facilitate their access to see the doctor each time they come for ante-and post-natal clinics.The mothers will be reminded of these visits through phone calls, text messages, and/or visits to their homes.Also, most mothers are usually eager to know how much weight their child has gained so we will weigh their child on every visit.
Sample size: Sample size calculation was calculated using a web-based sample size calculator of the UCSF Clinical & Translational Science Institute [42].Sample size calculation is based on the proportion of participants that practiced EBF and those that did not practice EBF.Based on a power of 80% and an  of 0.05 (two-sided), 64 participants per group will be needed to observe a 12% (assumed standard deviation of 24%) increase in the number of participants that practiced EBF as previously reported [43].This is shown in the formula below: The standard normal deviate for  = Z  = 1.960 The standard normal deviate for  = Z  = 0.842 A = (1/q 1 + 1/q 0 ) = 4.000

Data collection, management, and analysis
Data collection methods: The process of data collection is from March 2022 to November 2022.During each pre-and post-intervention appointment, the mothers will complete the questionnaire pack consisting of maternal demographic and KAP questions.The study focused on the following data: (1) sociodemographic information on the infants' age and sex, mothers' age, family income, education, and occupation; and (2) mothers' KAP.Infants' birth weight will be obtained from birth records and measured by nurses using infant weighing scales made available to all the twelve included hospitals.All the nurses in the control and intervention arm received training on anthropometric measurements, and the scales will be checked biweekly to ensure accuracy.Children's anthropometric measurements will be taken at each visit following standard procedures [43].Recumbent length will be measured using length boards with 0.1 cm precision.Infants will be weighed in light clothing using electronic scales with a precision of 100 g.All measurement instruments will be calibrated before each measurement session.All measurements will be performed twice.Standardization exercises for anthropometric measurements will be conducted during the initial training and repeated bi-monthly during the study.After the intervention, data will be collected to assess satisfaction with the intervention, challenges, and enabling factors from mothers' and study personnel's perspectives.To validate infant feeding practices, two categories will be established using self-reports: exclusive and non-exclusive breastfeeding.Data management: The participant's data will be treated with confi dentiality.All personal data collection and processing will be carried out according to European Union (EU) and national legislation.Personal data collected are those necessary to establish primary and secondary study outcomes.Unique identifi ers and a password-protected database will be used to protect the personal information of the study participants.

Summary of data collection methods
We will keep a written document with detailed information on the origin of all used human samples.All the study partners in the different study sites will receive training on procedures for handling pseudonymized data during study briefi ng/training.
The Principal Investigator (PI) (including the data analyst) will receive only key-coded data to ensure personal data protection.
The nurses in the study sites will be provided with fi le jackets, a small cupboard, and a padlock to ensure the safety of all collected data.The PI will have a fortifi ed steel cupboard for the storage of collated data and these data will remain safe in the cupboard for a minimum of fi ve years before they are destroyed.
Statistical methods: Statistical analysis will be conducted using Statistical Package for Social Science (SPSS version 25).
Descriptive statistics will be used to summarize and present demographic and clinical characteristics.Graphs and charts will be appropriately used to present socio-demographic variables where necessary.Categorical variables will be expressed as frequencies or percentages and quantitative variables as means and standard deviations if normally distributed and as median and inter-quartile range if not normally distributed.An intention-to-treat analysis will be conducted.All observations will be analyzed in the arm to which they will be randomized.
Multivariate binary logistic regression will be used to predict the level of EBF practice using the related associated factors as independent variables between the control and intervention arms.Adjusted odds ratio will be reported as the baseline parameter using the practice of EBF as an outcome variable while adjusting for age, type of family, marital status, education, family income, occupation, number of successful deliveries, type of delivery, and number of an ante-natal clinic visit(s) as cofounders in the regression model.In the analysis, the reference category will be those who did not practice EBF.A p-value of <0.05 will be used to indicate statistical signifi cance.
Low birth weight will be defi ned as birth weight below 2500 g.WHO 2019 child growth standards will be used to calculate WHZ and HAZ WHO Anthro Survey Analyser [44].Children with a WHZ below −2 will be considered wasted, and those with a HAZ below −2 will be considered stunted [44,45].All analyses will be by intention-to-treat.Comparisons between study arms on participants' baseline characteristics will be performed using binary logistic regression.
An In-Depth Interview (IDI) with all the study personnel in the intervention arm will be conducted at the end of the study to assess the mothers' and study personnel's experiences, facilitating, and limiting factors associated with the intervention.The IDI instrument to be used will be developed using the Pathfi nder International Tool Series guideline on conducting IDI [46].During the interview, notes will be taken, and data will be transcribed verbatim into English by the researcher and research assistant independently.A thematic content approach, guided by the Graneheim and Lundman framework, will be utilized for qualitative data [47].Responses from the IDIs will be read systematically through to identify the meaning units.A meaning unit will be defi ned as a string of text that expresses a single coherent thought, up to the point that the coherent thought changes [1].The meaning units will be coded using a describing cue related to the content of the meaning unit.Codes concerning the same subject will be grouped into categories.The interview guide will be used as a point of departure for grouping information deductively.Information obtained during the IDIs will be analyzed and merged according to the codes and themes.Original data will be reassessed after analysis to detect any concepts or information that may be missed.

Monitoring
Data monitoring: The Data and Safety Monitoring Board (DSMB) is composed of one of the authors, a biostatistician, and four external, independent experts on child and maternal health.The members are listed in Appendix 3. Specifi cally, the committee will: (1) review and evaluate the accumulated study data every two months for participant safety and (2) study the conduct and progress of the trial and make appropriate recommendations to the trial team.

Harms:
The major risk envisaged in this trial will be the exposure of the data of study participants.To mitigate this risk, participants' data will be treated with confi dentiality.• Interim period for analysis and documentation of study results.
• Debriefi ng of participants and dissemination of study results.

A. Interim
Every attempt will be made to reduce to an absolute minimum the interval between the completion of data collection and the release of the study results.We expect to take about % to & months to compile the fi nal results paper for an appropriate journal.

B. Reporting of study results
The study results will be released to the participating nurses, participants, and the general medical community Biological specimens: Not applicable

Ethics approval and consent to participate
The study will be conducted according to the Helsinki Declarations on ethical principles for medical research involving human subjects [48].Ethical approval was obtained from Chukwuemeka Odumegwu Ojukwu University Teaching Hospital Amaku Awka Anambra State Ethics Committee.Oral and written consent will be obtained from all participants.Unique identifi ers and a password-protected database will be used to protect the personal information of the study participants.Participant's data will be domiciled with the PI.Participants will be free to purposely leave the study at any time, without any effect on the care received in the study hospital.Ethical approval for any amendments to the protocol will be sought before implementing any changes if necessary.
al. 2020, breastfeeding mothers demonstrated poor awareness and understanding of EBF, which affected their practice.It revealed that mothers did not understand what constitutes EBF (i.e.what it involves and

3 .
To assess the experiences, facilitating, and limiting factors associated with the intervention.

2 .
Pregnant women attending the ante-natal clinic at the time of the study who are mentally unstable, critically ill, or refused to give their informed consent to participate in the study.Citation: Anetoh MU, Chigbo CG, Agujiobi CC, Aniugbo BM, Atakulu RO, et al. (2023) Effect of a hospital-based maternal counseling guide on exclusive breastfeeding practices in Anambra State, Nigeria: A protocol for a cluster-randomized controlled trial (HOME Trial).Open J Trop Med 7(1): 006-016.DOI: https://dx.doi.org/10.17352/ojtm.0000243. Nursing mothers with infants that have medical conditions such as cerebral palsy or physical disability and mothers and infants whose physician had recommended formula feeding due to breastfeeding contraindications because of the mothers' health condition (e.g., gynecological cancer such as CA breast or uterus, cancer chemotherapy, HIV-positive mothers who opted out of breastfeeding).
Awka-etiti.The trial has three periods -pre-intervention, intervention, and post-intervention periods.Intervention:The hospital-based counseling guide on EBF was designed to provide the required knowledge for educating mothers during ante-and post-natal clinics.Information from the WHO Infant and Young Child feeding practices[34], the Federal Ministry of Health Ante-natal care orientation package for health care providers[35], and results from our formative study were used to formulate the hospital-based counseling guide.The formative study includes a systematic review and a qualitative study.The systematic review was qualitative research on barriers and facilitators to exclusive breastfeeding practice in sub-Saharan African countries.Afterward, a qualitative study on factors affecting exclusive breastfeeding practice among nursing mothers in Southeast Nigeria was carried out to determine the context-specifi c barriers and facilitators of EBF practice from the nursing mothers' perspective.Results

[ 18 ,
36].It also includes information on the production of breast milk, the defi nition of exclusive breastfeeding, the benefi ts of exclusive breastfeeding for the mother and the child, the recommendations for effective breastfeeding, breastfeeding techniques (positioning and attachment), the on-demand and frequent feedings, the problems created by pre-lacteal, the adequacy of breastfeeding for six months, breast milk substitutes, myths and truths about EBF, preparation for EBF, solutions to the barriers to EBF practice from the formative study.The hospital-based counseling guide on EBF was given to four healthcare workers (doctor, pharmacist, nurse, and midwife) for their expert opinion to ensure robustness and allinclusive information.With the input of the four healthcare workers, the fi nal version of the hospital-based counseling guide on EBF was produced and then validated by an education expert.Each center's study personnel (nurse) was trained using the hospital-based counseling guide on EBF and study requirements by an experienced nurse/midwife.Training content covered basics of breastfeeding, EBF, benefi ts of EBF, myths vs. facts about breastfeeding, preparing for EBF, foods that can improve breast milk production in mothers, initiating breastfeeding after birth, colostrum and its benefi ts, frequency of breastfeeding, factors affecting EBF practice, breastfeeding positions, and breastmilk expression, and the survey instrument.

:
Our primary study outcome is exclusive breastfeeding for six months.Secondary outcomes are, mothers' KAP pre-and post-intervention, intention to practice EBF, initiation of breastfeeding within one hour of delivery, use of only colostrum or breast milk in the fi rst 3 days of life, children's mean birth weight, exclusive breastfeeding to one and three months, changes in child weight-for-length z-score (WHZ), and changes in child length-for-age z-score (HAZ).
' timeline: The participants in the intervention hospitals received EBF education/training using the formulated hospital-based counseling guide and the hospital's usual care while those in the control hospitals received EBF education/ training only from the hospital's usual care.The hospital's usual care is standard care specifi c to the hospital which does not have any standard plan/approach/format as education/ discussions are based on the mothers' questions during the clinics or what the nurse on duty deems fi t for the day.The intervention was initiated in the third pregnancy trimester and will continue until six months after birth.During pregnancy, the counseling interval will be at the 30 th week, 32 nd week, 34 th week, 36 th week, 38 th week, and 40 th week which coincides with their routine ante-natal clinic appointments.The interval is consistent with the 2016 WHO ANC model recommendation [35].After giving birth, participants in the intervention arm will, in addition, receive at least one counseling session per month, either in the hospital during post-natal clinic days at their homes, or through phone calls.The time was chosen to coincide with the dates of their immunization schedules.Participants in the control arm will only receive usual care as it pertains to the hospital.For both arms during the post-natal clinics, when the mothers come for the infants' vaccination, the infants will be assessed on developmental aspects based on weight, and Citation: Anetoh MU, Chigbo CG, Agujiobi CC, Aniugbo BM, Atakulu RO, et al. (2023) Effect of a hospital-based maternal counseling guide on exclusive breastfeeding practices in Anambra State, Nigeria: A protocol for a cluster-randomized controlled trial (HOME Trial).Open J Trop Med 7(1): 006-016.DOI: https://dx.doi.org/10.17352/ojtm.000024

7 . 849 Standardized 1 A
Effect Size = (E/S) = 0.500 Without correcting for clustering, total group size = N total = AB/(E/S) 2 = 125.58i.e., N 1 = 63, N 0 = 63, N total = 126 After adjustment for the cluster design, based on an assumed intracluster correlation coeffi cient of 0.047 and a fi xed cluster per arm of 6 treatment hospitals, the effective sample size increased to 120 patients per arm (i.e., a total of 240 patients).This is shown in the formula below: Cluster size = m = (1-p)/((C 1 /N 1 )-p) = 19.63,rounded to 20 Design Effect = 1+(p(m-1)) = 1.88Where p = Within-cluster correlation coeffi cient, C 1 = Number of Clusters in Group fi xed number of 3 clusters or 6 hospitals per arm (i.e., 12 hospitals in total for the trial).Each of the hospitals will therefore recruit 20 participants as they have a similar patient load.Due to potential attrition that could arise, we added four participants per hospital i.e., 20% of the calculated sample size to increase the number of participants in each arm to 144 (i.e., a total of 288 participants).Each of the hospitals had a target to recruit 24 participants.Recruitment: Participants' recruitment is in the second pregnancy trimester done through routine antenatal clinic visits, whereby pregnancy registration is done for pregnant women assessing care in the hospital and lasts for two months.This was complemented by a research assistant to ensure high coverage.The fi rst 24 women who met the inclusion criteria were recruited.Each recruited participant in the intervention arm received hospital-based information materials starting from the third trimester.The trial team recruited eligible study personnel/nurses or research assistants at each trial site.Each study participant was assigned to a study nurse/personnel working in the hospital, and they will be tracked with their mobile phone numbers where necessary.

Table 1 :
The World Health Organisation (WHO) trial registration dataset.Primary registry and trial identifying numberThe Pan African Clinical Trials Registry: https://pactr.samrc.ac.za/ (PACTR202203618023651) Mothers' KAP pre-and post-intervention, intention to practice EBF, initiation of breastfeeding within one hour of delivery, use of only colostrum or breast milk in the fi rst 3 days of life, children's mean birth weight, exclusive breastfeeding to one and three months, changes in child weight-for-length z-score (WHZ), changes in child length-for-age z-score (HAZ) Citation: Anetoh MU, Chigbo CG, Agujiobi CC, Aniugbo BM, Atakulu RO, et al. (2023) Effect of a hospital-based maternal counseling guide on exclusive breastfeeding practices in Anambra State, Nigeria: A protocol for a cluster-randomized controlled trial (HOME Trial).Open J Trop Med 7(1): 006-016.DOI: https://dx.doi.org/10.17352/ojtm.000024