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.: PACTR202106621156513 Date of Approval: 21/06/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of Behavioral Change Communication intervention on nutritional status and complementary feeding practice of children 6-23 months in Kersa District in Jimma zone, Southwest Ethiopia
Official scientific title The effect of Behavioral Change Communication intervention on nutritional status and complementary feeding practice of children 6-23 months in Kersa District in Jimma zone, Southwest Ethiopia
Brief summary describing the background and objectives of the trial Under nutrition is one of the leading causes of morbidity and mortality in children under the age of five in the world. Even though, Ethiopia has been made great effort in reduction of under nutrition in last two decade, still under 5 children are suffered in the huge burden of 38.4 %, 23.6 % and 9.9 % stunting, underweight and wasting, respectively (EDHS, 2016). A systematic review conducted in 2017 indicated that a significant association between under nutrition and complementary feeding practice and mothers/caretakers education ( Abdulahi A et al., 2017). The finding of this study will be relevant to help policy makers to improve the actual child feeding practice and promote multisectoral approach in cost-effective and sustainable way of food-based approach to reduce under nutrition. In Ethiopia, there has been no Randomized control Trial (RCT) which evaluate the effectiveness of BCC on improving child feeding practice to improve complementary feeding practice and nutritional status of 6-23 months of children. Thus, RCT is an important method to show how behavioural change communication influence the complementary feeding practice of mothers including adopting local traditional house hold food processing technology.The primary objective of the intervention trial is to evaluate the effectiveness of BCC in improving of infant and young children complementary feeding practice and nutritional status. The trial hypothesis is behavioural change communication will be effective on improvement of complementary feeding practice and nutritional status of infant and young children than in those who will not receive
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 11/08/2019
Actual trial start date 20/10/2019
Anticipated date of last follow up 20/08/2021
Actual Last follow-up date 15/09/2021
Anticipated target sample size (number of participants) 440
Actual target sample size (number of participants) 440
Recruitment status Completed
Publication URL no
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 Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Behavioral change communication Three session and follow up every 2 weeks For 1 year In the Intervention cluster, the eligible 6-23 months of age child mothers/care takers will receive Behavioral Change Communication (BCC) intervention on child feeding practice for 12 months by front-line health workers called Health Extension Workers (HEWs). The research team was responsible for recruiting 10 HEW and provided them training for 7 days and a then, each trained HEW was delivered BCC message for 22 child mothers pairs in different times within 3 sessions . The behavioral change communication (BCC) focused on Infant and child feeding practice and preparation of complementary foods from locally available cereal based ingredient through traditional food processing method. The mode of delivery are face to face discussion, role plays, poster, child feeding guideline and demonstration. In addition the house to house visits are conducted by HEWS and supervisors nearly every 2 weeks to follow the participants throughout the 12 months follow up period. 220
Control Group no intervention NA 1 year no intervention for control group 220 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children aged 6-23 months with mothers written informed consent Mothers of the selected children who were unable to communicate. . Children who received supplementation for treatment of malnutrition during the study period were excluded. 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 11/11/2015 Jimma university IRB
Ethics Committee Address
Street address City Postal code Country
none Jimma 378 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome change in height for age, weight for age and weight for height Z-scores Before administration of intervention at baseline and after 1 year at end line assessment.
Secondary Outcome Appropriate complementary feeding practice Before administration of intervention at baseline and after 1 year at completion of the intervention at end line assessment.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
kersa district Jimma jimma Jimma 378 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Jimma university none Jimma 378 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Jimma university none Jimma 378 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator meseret Tamrat mesetamrat@yahoo.com +251917804361 none
City Postal code Country Position/Affiliation
Jimma 378 Ethiopia Assistant professor
Role Name Email Phone Street address
Scientific Enquiries Tefera Belachew teferabelachew2@gmail.com 2510917804072 none
City Postal code Country Position/Affiliation
jimma 378 Ethiopia Professor
Role Name Email Phone Street address
Public Enquiries Desallegn Tamiru dessalegn97@gmail.com 251912373397 none
City Postal code Country Position/Affiliation
Jimma 378 Ethiopia Associate professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Statistical Analysis Plan one year Based on formal request, the principal investigator can share data after discussing with Jimma University Ethical review board
URL Results Available Results Summary Result Posting Date First Journal Publication Date
www.ju.edu.et 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