Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202203618023651 Date of Approval: 14/03/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of a hospital-based maternal counselling guide on exclusive breastfeeding practices in Anambra State, Nigeria: A cluster-randomized controlled trial (HOME Trial)
Official scientific title Effect of a hospital-based maternal counselling guide on exclusive breastfeeding practices in Anambra State, Nigeria: A cluster-randomized controlled trial (HOME Trial)
Brief summary describing the background and objectives of the trial 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 the year 2016 (i.e. 40%) in the same age bracket (Victora et al., 2016). EBF promotion is a vital public health strategy to prevent morbidity and mortality in infants. Breastfeeding is arguably the single most effective preventive intervention for reducing children's mortality less than five years (Koyanagi et al., 2009; WHO & UNICEF, 2003). The promotion of exclusive breastfeeding (EBF) has been a cornerstone of public health measures to promote child survival for several decades (Jones et al., 2003). 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 from the health care system (Kuhn et al., 2007). Although various studies have reported factors associated with EBF practice, no study has formulated and/or implemented any interventions addressing these factors. Interventions promoting optimal IYCF practices could prevent 19% of under-five deaths in countries with high mortality rates (Jones et al., 2003). Such intervention could improve nursing mothers' understanding, acceptance, and practise of EBF. Therefore, this study aims to formulate an improved hospital-based nutritional counselling guide on exclusive breastfeeding, implement it, and determine its effect in improving EBF on pregnant women and their future offspring in 12 secondary hospitals in Anambra State, Nigeria.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) HOME TRIAL
Disease(s) or condition(s) being studied Maternal and Child Health,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 20/01/2022
Actual trial start date
Anticipated date of last follow up 30/09/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 288
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Usual care MONTHLY 9 months The usual care 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 fit for the day. 144 Uncontrolled
Experimental Group HOME Trial MONTHLY 9 Months The intervention will be initiated in the third pregnancy trimester and will continue until six months after birth. During pregnancy, the counselling interval will be at 30th week, 32nd week, 34th week, 36th week, 38th week, and 40th week. The interval is consistent with 2016 WHO ANC model recommendation (Federal Ministry of Health, 2017). After giving birth, participants in the intervention arm will, in addition, receive at least one counselling visit per month during the child's infancy, either in the hospital during post-natal clinic days or at their homes or through phone calls. The time is chosen to coincide with the dates of the immunization schedules. Participants in the control arm will only receive usual care as it pertains to the hospital. 144
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 one year at the time of the study. 2. Pregnant women willing to give informed consent able to comply with scheduled visits and other study procedures. 1. 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. 2. 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., positive T-cell lymphotropic virus, untreated brucellosis, varicella, H1N1 influenza). Adult: 19 Year-44 Year 18 Year(s) 50 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/03/2022 Chukwuemeka Odumegwu Ojukwu University Teaching Hospital Amaku Awka Anambra State Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Chukwuemeka Odumegwu Ojukwu University Teaching Hospital Amaku Awka Anambra State Ethics Committee Awka 420007 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Exclusive breastfeeding to six months From birth to 6 months
Secondary Outcome Initiation of breastfeeding within one hour of delivery. Within one hour of delivery
Secondary Outcome Use of only colostrum or breast milk in the first 3 days of of life. Within the first 3 days of life.
Secondary Outcome Children's mean birth weight. At birth
Secondary Outcome Exclusive breastfeeding to one and three months. 1 to 3 months
Secondary Outcome Changes in child weight-for-height z-score (WHZ) From birth to 6 months
Secondary Outcome Changes in child height-for-age z-score (HAZ) From birth to 6 months
Secondary Outcome Mothers’ and study personnels’ experiences, facilitating, and limiting factors associated with the intervention. At the end of study
Secondary Outcome Maternal Knowledge, attitude and practice before intervention At the beginning of the study
Secondary Outcome Maternal knowledge, attitude and practice after intervention At the end of the study
Secondary Outcome Intention to practice EBF At the beginning of the study before intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Holy Rosary Specialist Hospital and Maternity Waterside Holy Rosary Specialist Hospital and Maternity Waterside Onitsha Anambra State Onitsha Nigeria
St Felix Catholic Specialist Hospital St Felix Catholic Specialist Hospital Nnewi Nnewi Nigeria
Immaculate Heart Specialist Hospital Immaculate Heart Specialist Hospital Nkpor-agu Onitsha Nigeria
Immaculate Heart Multi Specialist Hospital Immaculate Heart Multi Specialist Hospital Aguleri Aguleri Nigeria
Joint Hospital Joint Hospital Ozubulu Ozubulu Nigeria
General Hospital Enugu uwku General Hospital Enugu uwku Enugu uwku Nigeria
General Hospital Onitsha General Hospital Awka Road Onitsha Onitsha Nigeria
Our Lady of Lourdes Specialist Hospital Our Lady of Lourdes Specialist Hospital Ihiala Ihiala Nigeria
Regina Ceali Specialist Hospital Regina Ceali Specialist Hospital Awka Awka Nigeria
Immaculate Heart Hospital Umunze Immaculate Heart Hospital Umunze Umunze Nigeria
Visitation Hospital Visitation Hospital Umuchu Umuchu Nigeria
Our Lady of Fatima Specialist Hospital Our Lady of Fatima Specialist Hospital Awka etiti Awka etiti Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Yes Obinna Ikechukwu Ekwunife, Department of Clinical Pharmacy and Pharmacy Management Nnamdi Azikiwe University Awka 420007 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Izuchukwu Loveth Ejie Department of Clinical Pharmacy and Pharmacy Management, Faculty of Pharmaceutical Sciences, Nnamdi Azikiwe University Awka 420007 Nigeria Individual
Primary Sponsor Amarachi Triumph Nwabanne Department of Clinical Pharmacy and Pharmacy Management, Faculty of Pharmaceutical Sciences, Nnamdi Azikiwe University Awka 420007 Nigeria Individual
Primary Sponsor Ifeoma Blessing Umeh Department of Clinical Pharmacy and Pharmacy Management, Faculty of Pharmaceutical Sciences, Nnamdi Azikiwe University Awka 420007 Nigeria Individual
Primary Sponsor Maureen Ugonwa Anetoh Department of Clinical Pharmacy and Pharmacy Management, Faculty of Pharmaceutical Sciences, Nnamdi Azikiwe University Awka 420007 Nigeria Individual
Primary Sponsor Chijioke Maxwell Ofomata Department of Clinical Pharmacy and Pharmacy Management, Faculty of Pharmaceutical Sciences, Nnamdi Azikiwe University Awka 420007 Nigeria Individual
Primary Sponsor Benjamin Maduabuchukwu Aniugbo Department of Public Health, Tullamore, County Offaly County Offaly Ireland Individual
Primary Sponsor Chisom Godswill Chigbo Department of Applied Microbiology, Nnamdi Azikiwe University, Awka, Nigeria Awka 420007 Nigeria Individual
Primary Sponsor Noreen Ebelechukwu Agbapuonwu Department of Nursing Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria Nnewi 420007 Nigeria Individual
Primary Sponsor Brian Onyebuchi Ogbonna Department of Clinical Pharmacy and Pharmacy Management, Faculty of Pharmaceutical Sciences, Nnamdi Azikiwe University, Awka Awka 420007 Nigeria Individual
Primary Sponsor George Uchenna Eleje Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria Nnewi 420007 Nigeria Individual
Primary Sponsor Obinna Ikechukwu Ekwunife Department of Clinical Pharmacy and Pharmacy Management, Faculty of Pharmaceutical Sciences, Nnamdi Azikiwe University, Awka Awka 420007 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Ifeoma Blessing Umeh Department of Clinical Pharmacy and Pharmacy Management, Faculty of Pharmaceutical Sciences, Nnamdi Azikiwe University Awka 420007 Nigeria
Amarachi Triumph Nwabanne Department of Clinical Pharmacy and Pharmacy Management, Faculty of Pharmaceutical Sciences, Nnamdi Azikiwe University Awka 420007 Nigeria
Maureen Ugonwa Anetoh Department of Clinical Pharmacy and Pharmacy Management, Faculty of Pharmaceutical Sciences, Nnamdi Azikiwe University, Awka Awka 420007 Nigeria
Chijioke Maxwell Ofomata Department of Clinical Pharmacy and Pharmacy Management, Faculty of Pharmaceutical Sciences, Nnamdi Azikiwe University, Awka Awka 420007 Nigeria
Benjamin Maduabuchukwu Aniugbo Department of Public Health, Tullamore, County Offaly County Offaly Ireland
Chisom Godswill Chigbo Department of Applied Microbiology, Nnamdi Azikiwe University, Awka, Nigeria Awka 420007 Nigeria
Noreen Ebelechukwu Agbapuonwu Department of Nursing Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria Nnewi Nigeria
Lydia Ifeoma Eleje Measurement and Evaluation Unit, Department of Edcational Foundations, Faculty of Education Awka 420007 Nigeria
Brian Onyebuchi Ogbonna Department of Clinical Pharmacy and Pharmacy Management, Faculty of Pharmaceutical Sciences, Nnamdi Azikiwe University, Awka Awka 420007 Nigeria
Chinyere Ukamaka Onubogu Department of Paediatrics and 1Community Medicine, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria Nnewi Nigeria
George Uchenna Eleje Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria Nnewi Nigeria
Obinna Ikechukwu Ekwunife Department of Clinical Pharmacy and Pharmacy Management, Faculty of Pharmaceutical Sciences, Nnamdi Azikiwe University, Awka, Nigeria Awka 420007 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Obinna Ekwunife oi.ekwumife@unizik.edu.ng +2348062032501 Department of Clinical Pharmacy and Pharmacy Management, Faculty of Pharmaceutical Sciences, Nnamdi Azikiwe University
City Postal code Country Position/Affiliation
Awka 420007 Nigeria Reader
Role Name Email Phone Street address
Public Enquiries Izuchukeu Ejie li.ejie@unizik.edu.ng +2348030895765 Department of Clinical Pharmacy and Pharmacy Management Nnamdi Azikiwe University, Awka
City Postal code Country Position/Affiliation
Awka 420007 Nigeria Lecturer II
Role Name Email Phone Street address
Scientific Enquiries George Eleje gu.eleje@unizik.edu.ng +2348068117444 Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria
City Postal code Country Position/Affiliation
Nnewi 420007 Nigeria Reader
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Study Protocol December 2022 to March 2023 Open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information