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.: PACTR202201753436676 Date of Approval: 04/01/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness of Mobile Phone Messaging-Based Message Framing Intervention for Improving Maternal Health Service Uptake and New-born care practice in Jimma Zone, Ethiopia
Official scientific title Ulfa Mijuu
Brief summary describing the background and objectives of the trial Brief Summary: The field of mobile health (‘mHealth’) to improve the delivery of, and access to, health services and information offers potential solutions. Mobile phones have recently been adopted to disseminate health information and interventions (mHealth) in low- and middle-income countries. m-health is seen as a key area in achieving the global strategy for women’s and children’s health . While mHealth interventions hold promise, scientific studies evaluating their impact remain scarce. Objective: To examine the effectiveness of Mobile Phone Messaging-Based Message Framing Intervention for Improving Maternal Health Service Uptake and New-born care practice in Jimma Zone, Ethiopia
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Behavioural Change Communication
Anticipated trial start date 01/03/2023
Actual trial start date 02/05/2023
Anticipated date of last follow up 30/11/2023
Actual Last follow-up date 31/10/2023
Anticipated target sample size (number of participants) 588
Actual target sample size (number of participants) 588
Recruitment status Completed
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 a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group mobile phone based messaging Positively framed messages Six Months May 2, 2023 to October 31, 2023 An automated positively framed key message on maternal and child health will be sent to mothers every week 196
Experimental Group mobile phone based messaging Negatively framed messages Six Months, May 2, 2023 to October 31, 2023 An automated negatively framed key message on maternal and child health will be sent to mothers every week 196
Control Group Usual care Usual MCH services at Health facilities Six Months, May 2, 2023 to October 31, 2023 Usual MCH services at Health facilities 196 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant women with GA <20 weeks for current pregnancy, she/family member owns a mobile phone and who can provide written informed consent will be included in the trial Women who are critically ill at time of enrolment and pregnant women with systemic illness which need special ANC follow- up will be excluded Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 15 Year(s) 49 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 28/09/2020 Jimma University Institute of Review Board
Ethics Committee Address
Street address City Postal code Country
Kochi Jimma town 378 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Eight ANC visits, institutional deliveries, PNC visits, new born care practices Baseline and endline
Secondary Outcome Iron supplementation Uptake neonatal vaccinations Maternal and newborn morbidity Psychological outcomes – knowledge, attitude and self-efficacy Baseline and Endline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Jimma University Kochi Jimma town 378 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Jimma University Kochi Jimma town 378 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Jimma University Kochi Jimma town 378 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Jimma Zone Health Office Hagera Sibket Jimma town 178 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Gebeyehu Bulcha gebeyehubulcha@gmail.com +251911801923 Kochi
City Postal code Country Position/Affiliation
Jimma town 378 Ethiopia Jimma Zone Health Office
Role Name Email Phone Street address
Scientific Enquiries Zewdie Birhanu zbkoricha@yahoo.com +25117025852 Kochi
City Postal code Country Position/Affiliation
Jimma town 378 Ethiopia Jimma University Associate Professor
Role Name Email Phone Street address
Public Enquiries Hordofa Gutema pthordeg@gmail.com +251911791775 Kochi
City Postal code Country Position/Affiliation
Jimma town 378 Ethiopia Health Behaviour and Society Department Instructor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data (IPD) obtained through this study will be shared to other researchers with academic interest in maternal and newborn health according to basic ethical principles; data shared will be coded and anonymous with no participant Health information included. The prerequisites are approval of requests and executions of all applicable agreements. Data requests can be submitted 9 months after articles is published and will be made accessible for up to two years. Access to trail individual participants data can be made based on the request of qualified researcher on the area of maternal and newborn health who can submit research proposal and statistical analysis plan and willing to execute data sharing agreement. We strictly publish all results from the trail including the protocol. The accuracy of the results will be preserved and both positive as well as negative findings will be publicly available. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data requests can be submitted 9 months after articles is published and will be made accessible for up to two years. A qualified researcher engaging independent scientific research on the area of maternal and child health Review of research proposal and statistical analysis plan Execution of data sharing agreement
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