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.: PACTR201911690619601 Date of Registration: 29/11/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Improving the Consumption of Animal Source Foods for the Betterment of Women's and Children's Nutritional Status
Official scientific title Improving the Consumption of Animal Source Foods for the Betterment of Women's and Children's Nutritional Status
Brief summary describing the background and objectives of the trial Animal source foods (ASFs) are recommended to be part of a diversified diet. ASFs provide a range of nutritional importance; they are rich in nutrient concentration, they make difference in less amount, they add value to the nutritional performance of plant based diet, they contain insignificant antinutritional factors, and nutrients in them are with high bio availability. Including Ethiopia in many of economically not well to do countries the consumption of diversified diet is necked and it has been limited for ASFs and vitamin A rich fruits and vegetables. In the shade of the observed consumption behavior gap a cluster randomized controlled trial was designed with the aim to evaluate the effect of dietary diversification and infant and young child feeding Nutrition Education/Promotion/Behavioral Change Communication (BCC) on the consumption of ASFs and nutritional status of women and children.
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 02/12/2019
Actual trial start date
Anticipated date of last follow up 31/07/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 180
Actual target sample size (number of participants)
Recruitment status 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously 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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Nutrition Education A lesson per week Up to two months Mothers will attend dietary diversification and infant and young child feeding practice promotion lessons ( a lesson per week) every week for a length of two months. 90
Control Group No Intervention will be done to the Control Group They will be followed for six months for the sake of making statistical comparison with the experimental group. The control group will receive nothing. 90 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Mothers having infant and young children Non permanent resident mother-child pairs Mothers and children with anomalies hindering anthropometric measurements Mother and children abstained from the consumption of animal source foods for different reasons Mother and children with medical problem that can hinder their participation Infant: 13 Month(s)-24 Month(s) 6 Month(s) 23 Month(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 27/12/2017 Hawassa University College of Medicne and Health Sciences Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Menaheria to Referral Hospital Hawassa 1560 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of mothers and children who consumed animal source foods Before and after the intervention: Baseline, Midline and Endline
Secondary Outcome Nutritional status of mothers and children Before and after the intervention: Baseline, Midline and Endline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
College of Agriculture Hawassa University Street down to Piazza Hawassa 0005 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Livestock System Intensification Lab Collaborative Project Menaheria to Hawassa University Main Campus Hawassa 0005 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Hawassa University Menaheria to Hawassa University Main Campus Hawassa 0005 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Kansas State University Manhattan, KS 66506, United States Kansas 66506 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alemneh Kabeta Daba alemneh33@gmail.com +251910101982 Menaheria to Cheffee Road
City Postal code Country Position/Affiliation
Hawassa 0005 Ethiopia Assistant Professor at Hawassa University
Role Name Email Phone Street address
Public Enquiries Kebede Abegaz Ali Abegaz2005@yahoo.co.uk +251912021734 Membo to Addisu Menaheria
City Postal code Country Position/Affiliation
Hawassa 0005 Ethiopia Associate Professor at Hawassa University
Role Name Email Phone Street address
Scientific Enquiries Dejene Hailu Kassa dejenkassa@yahoo.com +251916829271 Atote to Nigistefura Road
City Postal code Country Position/Affiliation
Hawassa 1560 Ethiopia Associate Professor at Hawassa Univeristy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All Individual Participant Data will be shared in EpiData/EpiInfo/Spreed Sheet format immediately following the publication. The data will available to anyone interested. Additionally data analysis plan will be shared. Statistical Analysis Plan The IPD package will be shared after publication, after July 2021. It will be as per the rules and regulations of the PACTR and journals to publish the scientific papers.
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