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.: PACTR202101757871954 Date of Approval: 18/01/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effects Of Nutrition Education And Counseling Intervention On Materna Weight And Obstetric Outcomes Among Pregnant Women Of Gedeo Zone, SNNPR, Ethiopia, 2019, A Cluster Randomized Control Trial
Official scientific title Effects Of Nutrition Education And Counseling Intervention On Maternal Weight And Obstetric Outcomes Among Pregnant Women Of Gedeo Zone, SNNPR, Ethiopia, 2019, Cluster Randomized Control Trial
Brief summary describing the background and objectives of the trial Background: A commonly applied strategy to improve maternal nutrition during pregnancy is nutrition education and counseling. However, due to the scarcity of intervention trials, especially in Ethiopia, the effect of NEC on pregnancy outcomes is not well studied. Objective: To assess the Effect of Nutrition Education and counseling on the progress and outcomes of pregnancy among pregnant mothers in Public Health care institutions of Gedeo Zone, SNNPR, Ethiopia, from January – July 2019. Methods: Cluster randomized control trial study design was under taken. The control groups take the usual service from Health facility and the Experimental groups take the usual service from the health facilities plus NEC. Simple random sampling followed by cluster sampling was used to reach at eligible study Participants. A total sample of 235 (115 in Intervention group vs. 120 Controls) pregnant mothers that follows ANC at Public Hospitals and Health Centers of Gedeo Zone were included in the study. Descriptive statistics and further analysis were accomplished using STATA software, Differences between groups in terms of characteristics and obstetrical and neonatal outcomes was analyzed by using Student’s t test for continuous variables and chi-square test for categorical variables.
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 01/01/2019
Actual trial start date 07/03/2019
Anticipated date of last follow up 15/07/2019
Actual Last follow-up date 30/07/2019
Anticipated target sample size (number of participants) 235
Actual target sample size (number of participants) 235
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 from a statistics book Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group nutrition education and counseling three to four times 1 hour for each session nutrition education and counseling given for intervention group pregnant women 115
Control Group no usual practice no usual practice 120 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All Pregnant mothers in the second trimester (4th &5th month) of pregnancy attending ANC service at selected health institutions will be included in this study. : Pregnant mothers <18 years and comorbidity with complications and special requirements were excluded from the study. Diagnosed with chronic diseases like diabetes, hypertension, and twin pregnancy. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 15 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 07/03/2019 Dilla University College of Medical and Health Science Institution of Review Board
Ethics Committee Address
Street address City Postal code Country
Dilla University, College of Medicine and Health Science Dill 419 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome After nutrition education and counseling, mothers in the intervention group had better body weight than those in the control group (65.03kg vs. 56.8kg, p= 0.038). pregnant women weight gain increase
Secondary Outcome increase birth weight At the end of the study better Birth weight the women had
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
public health institution Gedeo zone SNNP Region, Ethiopia Dilla 0419 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Dilla university SNNP Region, Ethiopia Dilla 419 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor dilla university SNNP Region Ethiopia Dilla 419 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
abirham Shiferaw SNNP Region Dilla 419 Ethiopia
Sewitmariam Dessalegn SNNP Region Dilla 419 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Gizaw sisay gizsisay@gmail.com +251911580679 SNNP Region
City Postal code Country Position/Affiliation
Dilla 13 Ethiopia Lecturer
Role Name Email Phone Street address
Principal Investigator Adane Tesfaye adanetesfaye2006@gmail.com +251916857437 SNNP Region
City Postal code Country Position/Affiliation
Dilla 13 Ethiopia Lecturer
Role Name Email Phone Street address
Public Enquiries Mohammed Feyiso mamfys8@gmail.com +251926172375 SNNP Region
City Postal code Country Position/Affiliation
Dilla 13 Ethiopia lecturer and institutional review boardd member
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes the data cannot shared with anyone Study Protocol not applicable not applicable
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