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.: PACTR202108880303760 Date of Registration: 30/08/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness of positive deviant (hearth nutrition education) intervention to improve appropriate feeding practices and nutritional outcomes in West Omo Zone, Maji District: Southwest Ethiopia: A cluster randomized control trial
Official scientific title Effectiveness of positive deviant (hearth nutrition education) approach to improve appropriate feeding practices and nutritional status in West Omo Zone, Maji District: A Cluster Randomized Trial
Brief summary describing the background and objectives of the trial Background: Non-optimal infant and young child feeding practices (IYCFP) are linked to malnutrition, infant mortality, and children in poor countries, notably in Ethiopia. The majority of growth stalls occur within the first two years of life; hence, there is a need to discover interventions that enhance appropriate IYCF, and improving nutritional outcomes during the first two years of infant and young child is particularly important. Using the experience of mothers/caregivers who have come up with solutions to their own IYCFP problems and making a difference by educating others is particularly important to sustain behavioral changes in the resource-limited areas. However, such interventions are not widely implemented in Ethiopia. Study Objectives/hypotheses Research hypotheses -Positive deviant (hearth nutrition education) intervention significantly improve appropriate feeding practices (exclusive breastfeeding and complementary feeding), nutritional outcomes, knowledge, attitude and self-efficacy, health-seeking behaviors of mothers among the intervention arms compared with control arms Primary Objective This study has two primary objectives: First, at baseline, midline, and endline, this study will compare the effectiveness of a positive deviant (hearth nutrition education) intervention versus routine nutrition-related health education provided by health extension workers (community health workers) on mothers'/caregivers' knowledge, attitude, and self-efficacy regarding IYCFP. Second, the nutritional outcomes of young children (ages 6-24 months) in the control and intervention arms will be compared at baseline, 3-month follow-up, and 6-month follow-up. Child growth will be measured as length/height, weight, and weight-for-age at baseline and endline.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PDIIYCFPNO
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 25/09/2021
Actual trial start date 30/09/2021
Anticipated date of last follow up 25/03/2022
Actual Last follow-up date 03/04/2022
Anticipated target sample size (number of participants) 516
Actual target sample size (number of participants) 516
Recruitment status Active, not 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 Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Positive deviant intervention 24 home visits by positive deviant mothers and 12 group discussion for six months Positive deviance (hearth nutrition education) intervention The positive deviant (hearth nutrition education) sessions will be provided for the selected mothers in in the intervention for 12 days in groups to their nearby setting in the community. The hearth nutrition education elements such as knowledge, attitude, self-efficacy, appropriate feeding practice, hygiene and health seeking behavior. The positive deviant mothers will be assigned to the non-positive deviant (NPD) mothers and make regular visits to the household and provide information on exclusive breastfeeding, complementary feeding (MMF and MDD) practice, caring, hygiene, health seeking at the time of child illness and then wards, nutrition session, on how to cook and feed locally available food items to their children through follow-up visits for every two week to the intervention arms. The control arm will receive routine nutrition education by community health workers (Health Extension workers) A range of activities will be done simultaneously. Developing IEC materials and message promoting IYCFP such as leaflets, poster, and banners that has been produced based on the local context. Lastly, the outcome data will be conducted to evaluate and compare the intervention and control arms changes in appropriate IYCFP and nutritional outcomes. Intervention Development The intervention will be delivered through five stages: Baseline data collection (qualitative and quantitative ),selection, training and formation of positive deviant (hearth nutrition educators), mothers groups, training and demonstration by positive deviant mothers to the non-positive deviant mothers/caregivers with the comprehensive intervention manuals including how to cook and feed child, home visit and demonstration every fifteen days and providing information, education and communication materials as a continuous reminder to non-positive deviant mothers Monitoring and evaluation with well-prepared checklists will be carried out. Finally, midline and endline data collection and analysis will be done. 18
Control Group Routine nutrition education by health extension workers 24 home visits and 12 gropu discussion Six months Routine nutrition education is given by health extension workers as their activities to promote appropriate infant and young child feeding practices. 18 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Household’s infants and young children-mothers/caregivers participated at baseline data the children should be between 0 and 24 months of age, mothers/caregivers should have six months minimum residence status, no status to leave before the end of the study and have provided their verbal and written consent for participation. households with children younger than 2 years, those who did not participate at baseline data collection, those without a permanent residence, Infants and Young Children and mothers/caregivers who become seriously sick and mothers/caregivers who refuse to participate in the study will be excluded. Infant: 1 Month(s)-12 Month(s),Infant: 13 Month(s)-24 Month(s) 1 Day(s) 24 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 05/11/2020 Institute of Health Research and Postgraduate Office Jimma University
Ethics Committee Address
Street address City Postal code Country
n/a Jimma 378 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Appropriate infant and young child practices and nutritional outcomes 3 months and 6 months
Secondary Outcome Knowledge, attitude, and self-efficacy, health-seeking behavior, morbidity status 3 months and 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Shewaber area and Nifasber area N/A Maji Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Jimma University n/a Jimma 378 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Jimma University n/a Jimma 378 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abraham Gizaw abraham.tamirat@ju.edu.et +251911722420 n/a
City Postal code Country Position/Affiliation
Jimma 378 Ethiopia Assistant Professor and Researcher
Role Name Email Phone Street address
Scientific Enquiries Morankar Sudhakar morankarsn@yahoo.com +251917763778 n/a
City Postal code Country Position/Affiliation
Jimma 378 Ethiopia Professor and Researcher
Role Name Email Phone Street address
Public Enquiries Pradeep Sopory dz3594@wayne.edu +19895280100 n/a
City Postal code Country Position/Affiliation
Detroit United States of America Associate Professor and Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact on the following email: abrishntamirat@gmail.com or abraham.tamirat@ju.edu.et. Analytic Code,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis. Investigator whose proposed use of the data has been approved by an independent reviewer and those who are interested to conduct a meta-analysis.
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