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.: PACTR202008624731801 Date of Approval: 20/08/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFECT OF NUTRITIONAL EDUCATION AND HOME GARDENING ON FETO-MATERNAL OUTCOMES OF PREGNANT MOTHERS IN JIMMA ZONE, SOUTHWEST ETHIOPIA
Official scientific title EFFECT OF NUTRITIONAL EDUCATION AND HOME GARDENING ON FETO-MATERNAL OUTCOMES OF PREGNANT MOTHERS IN JIMMA ZONE, SOUTHWEST ETHIOPIA
Brief summary describing the background and objectives of the trial Background and objective of the trial Adequate maternal nutrition before and during pregnancy plays a central role for the health outcomes of the mother and neonate. Optimal nutrition during pregnancy has a significant contribution to normal gestational weight gain, prevention of maternal anemia, and fetal adverse outcomes. However, there is a paucity of information on the effect of nutrition education and home gardening on feto-maternal outcomes of pregnant mothers in low-income countries like Ethiopia, particularly in the study area. Therefore, the promotion of diverse diet in culturally acceptable ways through social and behavioral change communication tailored with home gardening that supplies diverse foods is one of an approach that has a great scope to improve diet and nutritional status of pregnant women and fetal outcomes. Objective: The main objective of this study is to assess the effect of nutritional education, promoting home garden use on feto-maternal outcomes of pregnant mothers in Jimma zone, southwest Ethiopia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 15/08/2020
Actual trial start date 15/08/2020
Anticipated date of last follow up 15/01/2021
Actual Last follow-up date 15/04/2021
Anticipated target sample size (number of participants) 350
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
IHRPGN 386 2012 Jimma university Institutional Review Board
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 Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Nutrition education 3 sessions 6 months Arm1;- pregnant mothers with her husband group:- nutrition education during enrolment, during 2nd trimester and third trimester on different topics plus 4 variety of home garden vegetables. 117
Experimental Group Nutrition education three sessions 6 months Arm 2:-pregnant mothers with her peer group:- nutrition education during enrolment, during 2nd trimester and third trimester on different topics plus 4 variety of home garden vegetables 117
Control Group Routine ANC follow up N/A As usual Routine ANC nutritional counseling 117 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
First-trimester pregnant mothers. Residents of the selected cluster and plan to give birth in her resident area. The first trimester is known (self-reported) chronic medical diseases (like diabetes mellitus, CHF, renal failure, epilepsy, HIV/AIDS. Not willing to give consent (not voluntarily to participate. Multiple pregnancy 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 06/06/2020 Jimma University institutional Review Board
Ethics Committee Address
Street address City Postal code Country
N/A Jimma 2378 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Birth weight within 24 hrs of delivery
Primary Outcome Maternal anemia at base line and end line
Secondary Outcome Minimum diet diversity of women At base line and end line
Secondary Outcome maternal complications at end line
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Babala kosa health post Oromia,JImma Zone, Mana Woreda Yabu 0000 Ethiopia
Haro health center Oromia,Jimma zone, Mana woreda Yebu Ethiopia
Kore lelisa health post Oromia, Jimma Zone, Yabu Ethiopia
Kenteri Health post Oromia,Jimma Zone,Mana woreda Yabu Ethiopia
Kemise Waraba health post Oromia,Jimma Zone,Mana woreda Yabu Ethiopia
Wakito madalu health post Oromia, Jimma zone,Seka chekorsa woreda Seka Ethiopia
Lemi lelisa health post Oromia,Jimma Zone,Mana woreda Yabu Ethiopia
Gudata bula health post Oromia, Jimma Zone,Mana woreda Yabu Ethiopia
Siba Bake Bake health post Oromia,Jimma Zone,seka chekorsa health post Seka Ethiopia
Meti health post Oromia,Jimma Zone, Seka Seka Ethiopia
Bidaru tuli Oromia,Jimma Zone,Seka chekorsa woreda Seka Ethiopia
Gepa seden health post Oromia,Jimma Zone,Seka chekorsa woreda Seka Ethiopia
Buyo Kechema health post Oromia,Jimma zone,Seka chekorsa Woreda Seka Ethiopia
Bore health post Oromia,Jimma Zone,Seka chekorsa Woreda Seka Ethiopia
Komo Hari Oromia ,Jimma zone,seka chekorsa woreda Seka Ethiopia
Dimtu Oromia,Jimma zone,Seka chekorsa Woreda Seka Ethiopia
Nase Health post Oromia ,Jimma Zone,Seka chekorsa worea Seka Ethiopia
Doyo Toli health post Oromia,Jimma Zone,Mana woreda Yabu Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Melesse Niguse Kuma Jimma University Jimma Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Oromia health biro Ethiopia Addis Ababa 21341 Ethiopia Governmental organization
COLLABORATORS
Name Street address City Postal code Country
Oromia Regional health Bureau Kirkose sub city around Sar bet Addis Ababa 24341 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Melesse Niguse Kuma meleseniguse@gmail.com +251917105735 N/A
City Postal code Country Position/Affiliation
Jimma 2378 Ethiopia PhD fellow
Role Name Email Phone Street address
Scientific Enquiries Tefera Belachew teferabelachew2@gmail.com +251917804072 N/a
City Postal code Country Position/Affiliation
Jimma 2378 Ethiopia Director of school of graduate studies Jimma University
Role Name Email Phone Street address
Public Enquiries Dessalegn Tamiru dessalegn97@gmail.com +251912373397 N/A
City Postal code Country Position/Affiliation
Jimma 2378 Ethiopia Head department of nutrition and dietetics Jimma University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All IPD that underlies the results reported in the publication will be accessed. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 6 months after publication and for 2 years thereafter Investigators whose proposed research has received IRB approval will access the data via a data repository following the execution of data uses agreement. Data access requests should be made via an application form detailing the specific requirements and the proposed research and publication plan. Then, it will be reviewed against specific criteria by the PI and promptly with no more than 3 months after receipt of the request. A data use agreement should be utilized which, at a minimum: (i) prohibits attempts to re-identify or contact trial participants; (ii) addresses any requirements regarding planned outputs of the proposed research, e.g. publication and acknowledgment requirements; and (iii) prohibits non-approved uses or further distribution of the data. Reasonable costs may be recovered from data requesters if appropriate but data sharing activities should not be profit generating.
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