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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607711896548 Date of Registration: 24/07/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of nutrition education promoting food-to-food fortification on feto-maternal outcomes among pregnant women in Gamo Zone, South Ethiopia
Official scientific title Effect of nutrition education promoting food-to-food fortification on feto-maternal outcomes among pregnant women in Gamo Zone, South Ethiopia
Brief summary describing the background and objectives of the trial Background Malnutrition among pregnant women remains a major global public health concern, particularly in low- and middle-income countries, where it substantially heightens the risk of adverse feto-maternal outcomes. Addressing poor maternal nutrition requires comprehensive and context appropriate interventions throughout pregnancy. However, evidence from Ethiopia remains limited regarding the effectiveness of culturally tailored nutrition education particularly approaches that promote food to food fortification and are delivered through health extension worker-led peer support groups. Generating such information is essential, as these strategies hold promise for improving feto-maternal outcomes while strengthening the sustainability of community based nutrition programs. This study is therefore designed to fill this critical knowledge gap within the Ethiopian context. Objectives General objective To assess the effect of NEP-FtFF on feto-maternal outcomes of pregnant women in Gamo zone, South Ethiopia Specific objectives 1. To determine the effect of NEP-FtFF on dietary diversity of pregnant women in Gamo zone, South Ethiopia 2. To determine the effect of NEP-FtFF on nutritional status of pregnant women in Gamo zone, South Ethiopia 3. To determine the effect of NEP-FtFF on birthweight of newborns in Gamo zone, South Ethiopia
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/10/2026
Actual trial start date
Anticipated date of last follow up 30/06/2027
Actual Last follow-up date
Anticipated target sample size (number of participants) 362
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 Non-randomised Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Education Three times or sessions (one per trimesters) 4-6 hours for each session Nutrition Education Promoting Food to Food Fortification (NEP-FtFF), which facilitated by Health Extension Workers (HEWs) led Peer Support Groups (PSUGs) will be given for pregnant women. The HEWs led PSUGs will utilize integrated nutrition intervention to guide pregnant women towards proper nutrition. In general, this intervention aims to change the nutrition behavior of pregnant women by using Motivational Interviewing (MI) principles as a guide and Social Ecological Model (SEM) as mechanism or Theory of Change (ToC). 181
Control Group Standard care Three times or sessions (one per trimester) 4-6 hours for each session The routine care and counselling service on nutrition for pregnant women in antenatal care service will be provided. 181 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant women who are resident in Gamo zone for at list six month and gestational age of less than 16 weeks and neonates who will deliver from those women will be recruited in this study. Those pregnant women who have known chronic medical illness and neonates who will be delivered with any congenital anomaly and those with birth weight is unknown and one week passed after delivery will be excluded. Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s),New born: 0 Day-1 Month 0 Day(s) 64 Year(s) Both
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 03/05/2026 IRB
Ethics Committee Address
Street address City Postal code Country
Arba Minch Arba Minch 0000 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Neonatal birth weight Wthin 24 hour following delivery
Secondary Outcome Maternal dietary diversity at 36th-38th gestational weeks
Secondary Outcome maternal nutritional status at 36th-38th gestational weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Gamo Zone Arba Minch Arba Minch 0000 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Arba Minch University Arba Minch Arba Minch 0000 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Arba Minch University 0 Arba Minch 000 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shitaye Shibiru shitayeshibiru@gmail.com +251926462518 000
City Postal code Country Position/Affiliation
Arba Minch 000 Ethiopia University Instructor
Role Name Email Phone Street address
Scientific Enquiries Tefera Belachew teferabelachew2@gmail.com +251917804072 000
City Postal code Country Position/Affiliation
Jimma 000 Ethiopia University Professor
Role Name Email Phone Street address
Public Enquiries Degu Jerene degujerene@gmail.com +251911546401 000
City Postal code Country Position/Affiliation
Arba Minch 000 Ethiopia Senior Epidemiologist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data underlying the results reported in this article will be made available following de-identification. This includes texts, tables, figures, and appendices. The study protocol will also be provided. Data will be available for access beginning nine months and ending 36 months following the article’s publication. Proposals must be submitted within this window by investigators whose proposed use has been approved by an independent review committee identified for this purpose. The data are provided primarily for meta-analysis. After 36 months, the data will remain available in our University’s data warehouse. However, at that point, the data will be accessible only with the deposited metadata and without investigator support. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 2 years Access to the data will be governed by a controlled access policy to ensure participant confidentiality and appropriate use. Access requests may be submitted by bona fide researchers from recognized academic, governmental, or non-profit research institutions, but the permitted use will be strictly restricted to non-commercial, scientific research purposes only, specifically focusing on the objectives outlined in the original consent forms, such as meta-analysis or replication studies. The process for requesting data will involve submitting a comprehensive application, including a detailed Data Access Request (DAR) form and a research protocol, which will then be reviewed by an independent Data Access Committee (DAC). This third-party committee will hold the final decision-making authority, and their review criteria will be rigorous, focusing primarily on the scientific merit and feasibility of the proposed study, the qualifications of the requesting investigator and their team, the adequacy of the applicant's data security plan, and strict adherence of the proposed research to the original informed consent agreements. Access will only be granted upon successful review and the execution of a formal Data Use Agreement (DUA).
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 02/07/2026 The words are missed while writing in the system. It must be similar. Effect of nutrition education promoting food-to-food fortification on feto-maternal outcomes Effect of nutrition education promoting food-to-food fortification on feto-maternal outcomes among pregnant women in Gamo Zone, South Ethiopia
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 02/07/2026 It is typo error Shitaye Shibiru, 0, Arba Minch, 0000, Ethiopia Gamo Zone, 0, Arba Minch, 0000, Ethiopia
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 10/07/2026 It is typo error Gamo Zone, 0, Arba Minch, 0000, Ethiopia Gamo Zone, Arba Minch, Arba Minch, 0000, Ethiopia
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 02/07/2026 Typo error TRUE, IRB, 0, Arba Minch, 0000, Ethiopia, , 03 May 2026, +251926462518, shitayeshibiru@gmail.com, 42586_38899_4737.pdf TRUE, IRB, 0, Arba Minch, 0000, Ethiopia, , 03 May 2026, +251926462518, irb@amu.edu.et, 42586_38899_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 10/07/2026 Typo error TRUE, IRB, 0, Arba Minch, 0000, Ethiopia, , 03 May 2026, +251926462518, irb@amu.edu.et, 42586_38899_4737.pdf TRUE, IRB, Arba Minch, Arba Minch, 0000, Ethiopia, , 03 May 2026, +251926462518, irb@amu.edu.et, 42586_38899_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 17/07/2026 Type error Arba Minch University, 0, Arba Minch, 0000, Ethiopia, University, Arba Minch University, Arba Minch, Arba Minch, 0000, Ethiopia, University,