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.: PACTR202311816542918 Date of Approval: 10/11/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Nutrition BCC through Community (Dala) leaders on feeding practices, Nutrition and health of infant and young children
Official scientific title Effect of Nutrition Behavior Change Communication Delivered Through Dala leaders on Feeding Practice, Nutrition and Health of Infant and Young Children in Agro-Pastoral Community of Afar region, Ethiopia: A Cluster Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Background: The first 1,000 days, from conception to two years of age, is a critical period of growth and development. Exposures to dietary, environmental, and other stressors during this period have been associated with an increased risk of poor health and nutritional outcomes, of which some are irreversible. Optimal infant and young child feeding is the major determinant for child health, growth and development. There exist high level of suboptimal feeding practice in Ethiopia in general, and in regional states with more pastoralist community in particular, such as Afar and Somali. In Afar, there exist high level of child mortality, under nutrition, suboptimal child feeding and WASH related problems which were documented for decades. To mitigate these problems identifying setting specific novel interventions are critical undertaking. Objective: This study aims to assess the effect of nutrition behavior change communication delivered through Dala leaders on complementary feeding practice, nutrition and health of infant and young children in agro-pastoralist community of Afar region.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) NBCC
Disease(s) or condition(s) being studied Feeding practice , Fever , diarrhea and cough ,Nutritional, Metabolic, Endocrine,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 02/07/2023
Actual trial start date 14/07/2023
Anticipated date of last follow up 15/12/2023
Actual Last follow-up date 29/12/2023
Anticipated target sample size (number of participants) 474
Actual target sample size (number of participants) 474
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 Trained Dala leaders led Nutrition Behavior Change Communication Training on the IYCF key message, providing specific take-home print materials, and cooking demonstrations at the beginning and after one month of the first training. And a four-round home visit starting in the third month of intervention. For six months The key messages will be communicated to mothers using talks, discussions, storytelling, experience sharing, negotiation, simulation, demonstrations, and problem-solving techniques in order to encourage and support behavior change in mothers and to increase mothers' confidence in their capacity to implement the advised feeding practices. Dala leaders used posters to conduct training sessions with mothers that were linguistically and culturally acceptable. 237
Control Group Usual care or routine care For six months The usual care provided by the existing community health system, which is BCC, is provided by HEW. 237 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Mothers/care givers of infants aged between 6 to 18 months , with singleton birth, who are residents in the selected clusters for at least 6 months and have no plans to move away during the study period. Mothers/care givers of infants with Hearing problem at the time of the baseline survey. Infant: 13 Month(s)-24 Month(s) 6 Month(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 13/07/2023 Jimma University Institute of Health Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Jimma Jimma 000000 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Minimum dietary diversity score Baseline and Endline data at 6 months
Secondary Outcome Minimum meal frequency Minimum acceptable diet Growth Frequency of common morbidity change Baseline and Endline data at 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dubti woreda Dubti Dubti Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Jimma University Jimma Jimma Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Jimma University Jimma Jimma Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Samara University Samara Samara Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Anwar Seid anuseid@gmail.com +251913047652 Samara
City Postal code Country Position/Affiliation
Samara Ethiopia Assistant Professor at Samara University
Role Name Email Phone Street address
Scientific Enquiries Kalkidan Hassen newewi333@gmail.com +251911370862 Jimma
City Postal code Country Position/Affiliation
Jimma Ethiopia Professor of Public Health and Nutrition at Jimma University
Role Name Email Phone Street address
Public Enquiries Teferera Belachew teferabelachew2@gmail.com +251917804072 Jimma
City Postal code Country Position/Affiliation
Jimma Ethiopia Professor of Human Nutrition at Jimma University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data has been collected during the trail, after deidentification. Informed Consent Form,Statistical Analysis Plan,Study Protocol We will share IDP within 12 months of the completion of the project. anyone who wishes to access the data. The information will be shared through emails, and any information request will be shared by scientific inquiries, public inquires and principal investigator.
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