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.: PACTR202308606236415 Date of Approval: 30/08/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of nutrition education on dietary intake and hemoglobin level among mild to moderately anemic pregnant mothers in Wondo Genet District, Sidama Region, South Ethiopia: a quasi experimental study
Official scientific title Effect of nutrition education on dietary intake and hemoglobin level among mild to moderately anemic pregnant mothers in Wondo Genet District, Sidama Region, South Ethiopia: a quasi experimental study
Brief summary describing the background and objectives of the trial Anemia in pregnancy continues to be a huge public health problem worldwide with multiple adverse outcomes on both mother and child especially in developing countries. The causes of anemia among pregnant women are multifactorial and may be associated with inadequate dietary intake of iron-rich foods. Many countries in the world are experiencing rapid social and economic changes which mostly have negative impacts on nutritional health of population subgroups. Nutrition education can no longer only serve as a remedy for malnutrition but a means of promoting and enhancing nutritional health in the wake of these changes (Wells et al., 2021). Molina and colleagues have suggested that the problem with nutrition education was more how the initiatives could be implemented effectively (Molina-López et al., 2013). What is needed is the support for nutrition practitioners to effectively implement the interventions. A generic framework has been proposed by Adems for the implementation of national nutrition education programmes (Adam, 2015). General Objective To evaluate the effect of nutrition education on hemoglobin level among mild to moderately anemic pregnant mothers in Wondo Genet district, Sidama Region, South Ethiopia Specific Objectives 1. To compare the hemoglobin level before and after receiving the nutrition education among pregnant mothers 2. To compare the knowledge on appropriate nutrition before and after receiving the nutrition education among pregnant mothers 3. To compare the dietary intake before and after nutrition education among pregnant mothers 4. To compare the difference in MUAC before and after nutrition education intervention among pregnant mothers
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Haematological Disorders,Infections and Infestations,Nutritional, Metabolic, Endocrine,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female,Mild-to-Moderately Anamia status
Purpose of the trial Education /Training
Anticipated trial start date 01/04/2023
Actual trial start date 01/05/2023
Anticipated date of last follow up 30/07/2023
Actual Last follow-up date 31/08/2023
Anticipated target sample size (number of participants) 104
Actual target sample size (number of participants) 104
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 Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Nutrition education with diet plan it contains 10 sessions and twice per each month for maximum 45 minutes. four months For pregnant woman, a nutrition education guideline on anemia was designed and used, with face-to-face classes and a written poster for counseling. The nutritional intervention education has been conducting two times in each month (every two weeks) and held on days of ANC appointment times and the total nutrition education intervention contains ten sessions. Causes of anemia, consequences of anemia in pregnancy, iron-rich foods, enhancers and inhibitors of iron absorption, and an iron-rich food-based diet plan are among the key nutritional messages delivered to the intervention group. Education intervention has been giving based on Health Belief Model theory: (1) susceptibility of the pregnant women to anemia (mild to moderate) due to inappropriate iron rich foods dietary practices, iron deficiency; (2) Causes and consequences of anemia such as increased risk of hemorrhage, sepsis, maternal mortality, perinatal mortality, decreased work productivity, impaired cognitive development of children and low birth weight due to poor health and poor nutrition; (3) benefits of right eating iron rich food, enhancers of iron absorptions, and reduction of iron inhibitors on anemic pregnant women, (4) barriers to practice appropriate iron rich food dietary practices; and (5) self-confidence/efficacy to follow iron rich food based dietary practices. The education has been providing using theoretical session, posters, and whiteboard. Individual pregnant women in the intervention group have been gating an iron-rich food-based diet plan at the end of session six, and follow-up has been doing every eight weeks during ANC visits and phone conversations. 52
Control Group routine health service given by nurses and health extension workers based on the general usual servi twice per month four months routine health service given by nurses and health extension workers based on the general usual service. 52 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant women aged 15–49 years. Who was willing to participate Who were been mild and moderate anemic was included in the study. Pregnant mothers who were living at list for six months in the study area Pregnant women who have known chronic disease were excluded from the study. Adult: 19 Year-44 Year 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 07/11/2022 Hawassa University College of Medicine and Health Sciences Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Tabor Subcity, Hawassa Ethiopia Hawassa, Ethiopia 1560 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Effect of nutrition education with general diet plan on hemoglobin level of pregnant women after 16 weeks of intervention /at End line of study
Secondary Outcome Change in nutritional knowledge of mothers, heath belief model constructs and dietary intake after 16 weeks of intervention/at End line of Intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aruma Health Center there is no streat address Aruma none Ethiopia
Wosha Soyama There is no street address. Wosha Soyama none Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Temesgen Yoseph Hawaria Tabor sub city, Ethiopia Hawassa none Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dawit Hawaria Tabor sub city, Hawassa, Ethiopia Hawassa none Ethiopia Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Temesgen Hawaria temesgenyoseph7@gmail.com +251926041999 Tabor Sub city, Hawassa, Ethiopia
City Postal code Country Position/Affiliation
Hawassa none Ethiopia MSc Student
Role Name Email Phone Street address
Public Enquiries Dawit Logita hawaria.dawit@gmail.com +251916044383 Tabor sub city, Hawassa Ethiiopia
City Postal code Country Position/Affiliation
Hawassa Ethiopia Assistant Professor of Tropical and Infectious Diseases School of Environmental Health Hawassa University
Role Name Email Phone Street address
Scientific Enquiries Zelalem Wondimagegne wudasiez@gmail.com +251911479506 Tabor Sub City, Hawassa, Ethiopia
City Postal code Country Position/Affiliation
Hawassa Ethiopia Assistant Professor of Human Nutrition College of Agriculture
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data has been collecting during the trail; after deidentification. Clinical Study Report,Statistical Analysis Plan,Study Protocol Immediately following publication, no end date anyone who wishes to access the data.
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