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.: PACTR201805003366358 Date of Approval: 03/05/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Nutrition
Official scientific title Effect of behavior change communication (bcc) through women¿s development army on optimal nutrition and health practices of pregnant women in west shoa zone, ambo districts, oromia, ethiopia
Brief summary describing the background and objectives of the trial Abstract Background: Pregnancy is such a critical phase in a woman's life, when the expecting mother needs optimal nutrients of superior qualities to support the developing fetus. Pregnancy places extra demands on the body systems of pregnant women, necessitating optimal intakes of essential nutrients. Essential nutrition actions have been adopted by the Ethiopian government and as an intervention framework with specific doable actions since 2005. This intervention has been rolling out both during contact with health facilities and through the health extension workers. However, there is no study that documented the practice of pregnant women in this regard.Women need about 240 kcal more food per day in the second trimester of pregnancy and 452 kcal more food per day in the third trimester. Women who enter pregnancy underweight need more calories to achieve adequate weight gain. Pregnancy increases a woman¿s nutritional requirements and micronutrient needs. Based on ENA concepts and different findings other than quantity and quality of diet; diseases prevention and treatment and supportive life style and care were very important for pregnant women in succeeding the general health of the fetus and their own health. Under the above theme, malaria treatment and prevention and de worming treatment and sanitation facilities and practices were key concepts of optimal nutrition and health practices The general objective of the study was to evaluate the Effect of BCC through Women¿s Development Army on Optimal Nutritional and Health Practices of Pregnant Women Methods: A Cluster Randomized Controlled Community Trial with baseline and end line measurements will be used among 744 pregnant women.The intervention(nutrition and Health BCC) will be started in April, 2016 for all pregnant women identified as intervention group and data collection for endline will be started in july 2016. The duration between baseline and endline measuremet will take 4 months.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CRCCT
Disease(s) or condition(s) being studied Optimal and nutritional practices Nutritional status DDS Iron Supplementation
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 05/04/2016
Actual trial start date 08/04/2016
Anticipated date of last follow up 20/07/2016
Actual Last follow-up date 22/07/2016
Anticipated target sample size (number of participants) 750
Actual target sample size (number of participants) 744
Recruitment status Completed
Publication URL Not Yet published
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 randomized 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 Behaviour change communication (BCC) 1days/2hr length in a week 4 MONTHS Health developmenet Army was selected from the community and traing was given on optimal nutrition and health related issues for 5 days then they gave gave BCC intervention based on the objective and intervention protocol for pregnant women one day in a week for 2 hours for 4 months. 372 Historical
Control Group Nothing is given Nothing 3months The thirteen Kebele's (two from urban and eleven from rural strata) from Ambo districts which was involved at baseline survey was used for end line data measurement. Each kebele's has its own Got's(Cluster's). Then the number of Got's in each kebele's was listed and determined. 372 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant women selected at the baseline assessement. Permanent residents Age 18-45 years Pregnant women who will be mentally ill Unable to speak and hear. 18 Year(s) 45 Year(s) Female
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 15/02/2016 Institutional Review Board of Jimma University
Ethics Committee Address
Street address City Postal code Country
Jimma University Jimma 378 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Optimal nutrition and health practices 4 months
Primary Outcome nutritional health behavior of pregnant women (Dietary Diversity, supplementation and micro nutrient intake) After 4 months
Primary Outcome nutritional and self reported morbidity status of pregnant women After 4 months
Secondary Outcome health seeking behavior(FANC, PNC and delivery care) and Weight change and Birth outcome. After 4 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Rural Community Ambo district Ambo 19 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Jimma University Jimma Jimma 376 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Jimma University Jimma Jimma 378 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Professor Tefera Belachew Jimma University Jimma 376 Ethiopia
Ambo University Ambo Ambo 19 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mitsiwat Abebe mitseabe@gmail.com +251911002396 Ambo University
City Postal code Country Position/Affiliation
Ambo 19 Ethiopia Lecturer at Ambo University, Ambo, Ethiopia.
Role Name Email Phone Street address
Public Enquiries Mitsiwat Abebe mitseabe@gmail.com +251911002396 Ambo University
City Postal code Country Position/Affiliation
Ambo 19 Ethiopia Lecturer at Ambo University, Ambo, Ethiopia.
Role Name Email Phone Street address
Scientific Enquiries Tefera Belachew teferabelachew@gmail.com +251917804072 Jimma University
City Postal code Country Position/Affiliation
Jimma 378 Ethiopia College of Public Health and Medical Sciences, Jimma University, Jimma, Ethiopia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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