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.: PACTR202201731802989 Date of Approval: 24/01/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of promoting fruits and vegetables consumption on maternal nutritional status and birth weight at Robe and Goba Towns, South East Ethiopia: a cluster randomized controlled trial
Official scientific title Effect of promoting fruits and vegetables consumption on maternal nutritional status and birth weight at Robe and Goba Towns, Southeast Ethiopia: a cluster randomized controlled trial
Brief summary describing the background and objectives of the trial Gestational weight gain, Undernutrition, a lack of dietary diversity, anemia (low hemoglobin), and adverse birth outcome such as low birth weight (LBW) are serious public health concerns globally, particularly in low-income countries including Ethiopia. Maternal nutrition is recognized as one of the determinants of fetal growth. Gestational weight gain is a unique and complex biological phenomenon and is one of the factors that support normal fetal growth and development. Poor maternal nutrition, both before and during pregnancy, is associated with adverse pregnancy outcomes including intrauterine growth restriction, which greatly increases the risk of neonatal deaths, low birth weight, preterm birth, and stunting. The women's dietary diversity score is a simple, rapid, and useful proxy measure of micronutrient intake adequacy which, if found to be associated with reduced risk of maternal anemia and pregnancy outcomes, can easily be integrated into public health interventions targeting pregnant women. LBW is closely associated with increased fetal and neonatal mortality, morbidity, and impaired growth and cognitive development. Consumption of fruits and vegetables is promoted as part of a healthful diet; however, intakes are typically lower than recommended levels. Hence, appropriate nutrition education on the maternal diet during pregnancy seems to be of high priority to promote positive pregnancy outcomes [18]. Thus, this study employs the health belief model (HBM) and the theory of planned behavior (TPB) during counseling. Nevertheless, there is a paucity of evidence on the effect of promoting fruit and vegetable consumption on maternal nutritional status and birth outcomes in low-income countries, including Ethiopia, particularly in Robe and Goba towns in Southeast Ethiopia. Thus, we intend to assess the effect of promoting fruit and vegetable consumption on maternal nutritional status and birth outcomes at Robe and Goba towns, Southeast Ethiopia
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/06/2021
Actual trial start date 02/06/2021
Anticipated date of last follow up 30/11/2021
Actual Last follow-up date 01/12/2021
Anticipated target sample size (number of participants) 454
Actual target sample size (number of participants) 447
Recruitment status Closed to recruitment,follow-up continuing
Publication URL NA
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 by using procedures such as coin-tossing or dice-rolling 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 Nutrition education is delivered two times per month (every 2 weeks per month) for pregnant women. Nutrition education is delivered for pregnant women for 6 months Pregnant women have been assessed for eligibility. Pregnant women in the intervention and control groups have been matched in terms of the trimester. Eligible pregnant women have been allocated to the intervention and control (comparison) group. Baseline and end-line assessments have been made for 2 groups. After baseline data collection, the intervention has started in June and was relentless for 6 months. Participants in the intervention have received nutrition education every 2 weeks for 6 months. Nutrition education has been delivered for an hour every session for respondents (in-group). The lesson was based on the FAO nutrition-related KAP guidelines and the Alive thrive manual. Nutrition education was delivered through interactive, group discussion, stories, and poster presentation. Intervention and control groups receive nutrition education routinely by urban health extension workers. 227
Control Group Control group Often routinely The controls group receive routine care from other professionals 227 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
First-trimester pregnant women who are permanent residents in the study area until delivery will be included in the study. Pregnant women who can not respond to the interview questions. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 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 11/06/2020 Institutional Review Board of Jimma University Ethiopia
Ethics Committee Address
Street address City Postal code Country
Jimma Jimma 378 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Dietary diversity score late first, second and third trimester of pregnancy
Secondary Outcome Gestational weight gain, Undernutrition, hemoglobin level, time to minimum weight gain, birth weight late first, second and third trimester of pregnancy for gestational weight gain, Undernutrition, hemoglobin level, and time to minimum weight gain, within an hour after birth for birth weight.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
health facility kebeles of Robe Robe 4540 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Principal investigator Jimma Addis Ababa 378 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
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Tefera Belachew teferabelachew2@gmail.com +251917804072 Jimma
City Postal code Country Position/Affiliation
Jimma 378 Ethiopia Director of school of studies Jimma University
Role Name Email Phone Street address
Principal Investigator Girma Beressa gberessa@gmail.com +251912824210 Goba
City Postal code Country Position/Affiliation
Addis Ababa 4540 Ethiopia PhD fellow
Role Name Email Phone Street address
Public Enquiries Desalegn Tamiru dessalegn97@gmail.com +251912373397 Jimma
City Postal code Country Position/Affiliation
Addis Ababa 378 Ethiopia Department Head of Nutrition and Dietetics Jimma University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The study subject data will be available. All of the individual study subject data is collected during the trial. The statistical analysis plan and informed consent will be available. The results of the study will be shared within a year after the completion date of the data collection/trial study. Baseline and end-line study subjects for each arm (intervention and control) number of the research study subjects through each stage of a study in a flow diagram, unfavorable change in the health of study subjects and outcome measures will be reported. Informed Consent Form,Statistical Analysis Plan The results of the study will be shared within a year after the completion of the study. The results of the study will be shared within a year after the completion of the study.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
NA 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