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.: PACTR201809544276357 Date of Approval: 14/09/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Using community-based and peer-guided nutrition education to create awareness about iodine deficiency disorder and iodized salt in Dawro Zone, South West Ethiopia
Official scientific title Effect of behavior change communication on iodine deficiency disorder and iodized salt in Dawro zone, south west Ethiopia: An intervention study
Brief summary describing the background and objectives of the trial Iodine deficiency is a major public health problem and the world’s single most significant cause of preventable brain damage and mental retardation in children.The main objective of this study was to assess the effect of iodine nutrition related BCC intervention in increasing people’s knowledge about IDD and iodized salt, changing their attitude and improving their practice of iodized salt. Its main focus was to evaluate change in KAP identified by comparing values of indicators from before (baseline) and after nine months consecutive interventions of BCC (end line) in the study area.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) HEWs IDD IGN IQ RCT USI
Disease(s) or condition(s) being studied Digestive System,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 01/03/2016
Actual trial start date 24/10/2016
Anticipated date of last follow up 24/06/2017
Actual Last follow-up date 24/09/2018
Anticipated target sample size (number of participants) 652
Actual target sample size (number of participants) 647
Recruitment status Closed to recruitment,follow-up continuing
Publication URL Asfaw A, Belachew T. Effect of behavior change communication on iodine deficiency disorder and iodized salt in Dawro zone, south west Ethiopia: An Intervention Study. BMC nutrition. Year. Vol: page numbers
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 by using procedures such as coin-tossing or dice-rolling Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group RCT For 9 months For 9 months A 9 months nutrition education about iodine deficiency disorder and iodized salt consumption was given by trained peer groups for women in intervention arm. 323
Control Group RCT For 9 months For 9 months The control groups received the routine services as usual. 324 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All women in the age range of 15-49 years were included. Women who refuse to give oral consent. Women who were outside the age range were excluded. Seriously ill women at the time of recruitment Adult: 19 Year-44 Year 15 Year(s) 49 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 10/02/2016 Jimma University Ethical committee
Ethics Committee Address
Street address City Postal code Country
Oromia, Jimma Jimma 251378 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Increased people’s knowledge about IDD and iodized salt, positive attitude towards and improved practice of iodized salt. At base and end lines
Secondary Outcome Improved iodine nutrition status At endline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tarcha health post lead center Dawro zone Tarcha 25115 Ethiopia
Gozo Shasho Health Post Gozo Shasho Turi 251101 Ethiopia
Gozo Bamush Health Post Gozo Bamush Waka 25109 Ethiopia
Gessa Chere Loma Gessa 25117 Ethiopia
Yello Worbeti Loma Yello 25123 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Jimma University Oromia, Jimma Jimma 251378 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Agize Asfaw agisha238@gmail.com +251911542030 SNNPR
City Postal code Country Position/Affiliation
Hawassa 251007 Ethiopia Lecturer at wolkite University
Role Name Email Phone Street address
Public Enquiries Tefera Belachew teferabelachew@gmail.com +251917804072 Oromia, Jimma
City Postal code Country Position/Affiliation
Jimma 251378 Ethiopia Professor of human nutrition
Role Name Email Phone Street address
Scientific Enquiries Mirkuzie Woldie mirkuzie.woldie@ju.edu.et +251471120945 Oromia, Jimma
City Postal code Country Position/Affiliation
Jimma 251378 Ethiopia Professor of public health
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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