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.: PACTR202307540188312 Date of Approval: 10/07/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of social cognitive theory based health education intervention on exclusive breastfeeding practice.
Official scientific title Effects of social cognitive theory based health education intervention on exclusive breastfeeding practice among postnatal mothers in a hospital in Imo state Nigeria..
Brief summary describing the background and objectives of the trial Breastfeeding is the normal way of providing young infants with the nutrients they need for healthy growth and development. Virtually all mothers can breastfeed, provided they have accurate information, and the support of their family, the health care system and society at large World health Organization. Breastfeeding has been strongly recommended by WHO and United Nations and United Nations International Children’s Emergency Fund (UNICEF) as the ideal and appropriate infant feeding for optimal growth and development. Breast milk is recommended that complementary foods be added to the infant’s diet at six months of age and that breastfeeding continue up to two years of age and beyond. This trial aims at determining the effect of health education intervention based on social cognitive theory on exclusive breastfeeding among ante-natal mothers attending, Imo State Specialist Hospital, Imo state, Nigeria.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Nil
Disease(s) or condition(s) being studied Exclusive breastfeeding
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 04/07/2023
Actual trial start date 12/07/2023
Anticipated date of last follow up 10/01/2024
Actual Last follow-up date 12/02/2024
Anticipated target sample size (number of participants) 204
Actual target sample size (number of participants) 204
Recruitment status Recruiting
Publication URL Nil
Secondary Ids Issuing authority/Trial register
Ugwu Chijioke Irene Phd student
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 a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Intervention group Once a week 3 weeks The intervention programme, named Social Cognitive Theory (SCT), aims to improve exclusive breastfeeding (EBF) among mothers as well as improve their knowledge, self-efficacy and social support.. The intervention will comprised of five modules, design to cover each of the constructs of social cognitive theory. The knowledge construct, goal/intention module, self-efficacy , social support and outcome expectancy. 102
Control Group Control group Once a week 3 weeks Participants in the control group will receive immunization education and standard care. 102 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All antenatal mothers, who had an uncomplicated pregnancy. Complicated pregnancy defined as one with underlying medical condition such as hypertension, diabetes and obesity. Gestational week from 26 weeks- 34weeks. Attended ANC in Imo state Specialist Hospital during the study period. Did not deliver a still born baby. Antenatal mother who can speak and understand English . Mothers on drugs, medication who are unable to breastfeed. Known medical condition(s) including mental illness that might hinder breastfeeding. Mothers who had an uncomplicated pregnancy. Complicated pregnancy defined as one with underlying medical condition such as hypertension, diabetes and obesity. Antenatal mother who cannot speak and understand English and Igbo Adult: 19 Year-44 Year 18 Year(s) 45 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 11/10/2021 Ethics Committee for Research Involving Human Subjects Universiti Putra Malaysia
Ethics Committee Address
Street address City Postal code Country
Persiaran Universiti 1, 43400 Serdang, Selangor Serdang 43400 Malaysia
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 05/10/2022 Imo state Specialist Hospital Owerri Health Research Ethics
Ethics Committee Address
Street address City Postal code Country
Off Port Harcourt Road Owerri, Imo state New owerri 1557 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Exclusive breastfeeding Baseline, 3 months and 6 months
Secondary Outcome Knowledge, goal/intention, self-efficacy, socio structural, social support and outcome expectancy Baseline, 3 months and 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Imo state Specialist hospital Off Port Harcourt Road, New Owerri, Imo State, Nigeria Owerri 1557 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Mr Obinna Okoroike No 5 Amaigbo Street Owerri Owerri 460271 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mr Obinna Okoroike No 5, Amaigbo Street Owerri Owerri 460271 Nigeria Business
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Norliza Ahmad lizaahmad@upm.edu.my +60192710577 Faculty of Medicine and Health Sciences Universiti Putra Malaysia
City Postal code Country Position/Affiliation
Serdang 43400 Malaysia Supervisor
Role Name Email Phone Street address
Scientific Enquiries Uche Uchegbu druchegbujnr@yahoo.com +23408037090618 Federal Medical Centre Owerri, Imo state Nigeria
City Postal code Country Position/Affiliation
Owerri 460281 Nigeria Field supervisor
Role Name Email Phone Street address
Public Enquiries Chijioke Irene Ugwu ireneokoroike01@gmail.com +601126244007 Department of Community, Faculty of Medicine and Health Sciences Universiti Putra Malaysia
City Postal code Country Position/Affiliation
Serdang 434000 Malaysia Universiti Putra Universiti
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participant data will be available and all the individual participant data collected during the data collection will be shared. Data will be stored in SPSS and results generated will be published in Scopus index journal for public use. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol All data will be available for public use starting june 2024. No end date Anyone who wishes to access the data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Data will be available at https://www.google.com/search?q=mjmhs&source=hp&ei=tNikZKCpKN-o4-EPrpiK0AU&iflsig=AD69kcEAAAAAZKTmxKQQJceTLRrZHYt7GuBC6m5N6P18&ved=0ahUKEwig06rdxfb_AhVf1DgGHS6MAloQ4dUDCAk&ua 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