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.: PACTR201709002477373 Date of Approval: 27/07/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of in-service nutritional training on ANC counseling quality and maternal knowldge and practice
Official scientific title Efficacy of in-service nutritional training on ANC counseling quality and maternal knowldge and practice
Brief summary describing the background and objectives of the trial Background: It is critical for pregnant women to have adequate knowledge in order to achieve optimal nutritional status during pregnancy. Healthy and nutritious diet is essential component of ANC along with other clinical advice.it is critical for health care providers to have adequate knowledge and skill necessary to be able to provide sufficient nutritional information for pregnant women. However, most studies show lack of adequate knowledge and skill among health care providers. Lack of knowledge can be considered as a primary cause for lack of confidence and insufficient practice of counseling among health care providers which might lead to insufficient nutritional knowledge and practice of pregnant women. Objective: To assess the efficacy of in-service nutritional training in improving ANC counseling quality of health care providers and knowledge and practice of pregnant women regarding maternal nutrition.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth,pregnancy nutrition
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 31/07/2017
Actual trial start date
Anticipated date of last follow up 08/09/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 600
Actual target sample size (number of participants)
Recruitment status Not yet 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 Dynamic Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Nutrition education and counseling package 3 months A two days training on pregnancy nutrition and appropriate counseling skill will be given to health care providers working in ANC of intervention health centers plus a take home brochure will be given to pregnant women attending intervention health centers 300
Control Group Non intervention 3 months No intervention will be given i.e they will continue their usual practice 300
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
women below 28 weeks of gestation women above 28 weeks of gestation women with chronic disease 18 Year(s) 49 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 03/02/2017 Addis Ababa university research and ethics comitte
Ethics Committee Address
Street address City Postal code Country
Ambasador addis ababa Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome knowldege of women during endline
Primary Outcome knowledege of health care providers during endline
Secondary Outcome practice of women during endline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Addis Ababa health centers kotebe Addis Ababa Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Addis ababa university addis ababa Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Addis ababa university Tikur anbessa addis ababa Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Dr. seifu hagos Jemmo addis ababa Ethiopia
Dr. bilal shikur Bethel addis ababa Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Afrah Omer afrahsanni@gmail.com +251 944 25 77 32 Bethel
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Student in public health
Role Name Email Phone Street address
Public Enquiries Seifu Hagos seif_h23@yahoo.com +251 11 61 35 77 Jemmo
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Advisor/ PHD
Role Name Email Phone Street address
Scientific Enquiries Bilal Shikur lebiluka@yahoo.com +251 911 47 53 75 Bethel
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Advisor/ Assistant professor
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information