Maternal Anemia in Pregnancy, Before Birth, Maternal; Malnutrition, Affecting Fetus
Conditions
Keywords
Pregnant women, Undernutrition, Anemia, Amaranth grain, Sidama region, Ethiopia
Brief summary
Introduction: In Ethiopia, maternal malnutrition is a severe public health issue. Underweight and anaemia are the two most common nutritional problems in pregnant women, and they often coexist. Methods: A community-based cross-sectional study will be undertaken on a sample of 528 pregnant women in their first trimester to investigate the prevalence of anemia and associated risk factors, as well as the prevalence of co-existing anemia and undernutrition. Following that, a six-month parallel-group community-based randomized controlled trial will be conducted among 306 anemic women to assess the effect of locally prepared amaranth grain flatbread on hemoglobin concentration and anemia prevalence when compared to maize bread, which is commonly consumed among pregnant women.
Detailed description
Introduction: In Ethiopia, maternal malnutrition is a major public health concern. Underweight and anaemia are the two most common nutritional disorders in pregnant women, and they frequently co-exist. A prevalent kind of nutritional anaemia is iron-deficiency anaemia (IDA). These issues are primarily caused by a lack of important micro and macronutrients in the diet, as pregnant women eat primarily cereal-based foods. As a result, the burden of under-nutrition in Ethiopia necessitates a more in-depth investigation of underused crops that are high in nutrients and have the potential to minimize food and nutrition insecurity. Although the amaranth plant grows widely in Ethiopia and can boost food intake, its nutritional potential has yet to be acknowledged by community consumers and health professionals. Methods: A community-based cross-sectional study will be conducted on a sample of 528 pregnant women in their first trimester to examine the prevalence of anemia and identify its risk factors and determine the prevalence of co-existing anemia and under-nutrition among pregnant women. From pregnant women who will be diagnosed for anemia, C-reactive protein (CRP) and serum ferritin will be analyzed to determine IDA. Following this, a parallel-group community-based randomized controlled trial will be conducted for six months among 306 anemic women to evaluate the effect of locally prepared amaranth grain flat-bread on hemoglobin concentration and anemia prevalence compared to the frequently consumed maize bread among pregnant women. A multi-stage sampling method will be utilized to select eligible pregnant women. The households with pregnant women will be identified by conducting the house-to-house census.For categorical variables, summary measures will be presented as absolute frequencies and percentages, but for numerical variables, the mean with standard deviation (SD) will be utilized as a descriptive measure after the distribution is checked for normality. A multi-level mixed-effect logistic/linear regression model will be used to account for between and with cluster effects. We will be used intention-to-treat analyses approach.
Interventions
COMBINATION_PRODUCTAmaranth grain flat bread
The recipe will be produced according to the recommended dietary allowance (RDA); based on RDA, 200 g of flat-bread (30% chickpea and 70% amaranth grain) comprised 30 mg of iron, which can satisfy 50% of RDA supposing 15-20% iron absorption (54). A prior study concluded that the acceptability was satisfactory in the community (55). Also, a study from the Hawassa University Department of Food Sciences reported that amaranth-grain flat-bread was safe for consumption for 48 hours after preparation and improved the nutritional values (56). To lower the phytate levels in the amaranth grain, home-level processing will be used. For 24 hours, amaranth grain will be soaked in water with 5 milliliters of lemon juice per 100 milliliters of water, and it will germinate for 72 hours. It will be sun-dried, roasted, and ground using a nearby electrical mill before fermented bread is made
Sponsors
Nestlé Foundation
Hawassa University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
The trial subjects, bread distributors, and outcome assessors (data collectors) will be all unaware of the study groups assignment and bread content. The bread distributers for the maize and amaranth groups will be distinct, and there will be 12 bread-distributers, one for each kebele. Twelve boxes, one for each kebele, will be packed and tagged with the name of the pregnant women. Every day, each bread-distributer fed the pregnant women at their home, under their close supervision. Unopened bread will be returned and recorded by the coordinator each day in the event of absences or refusals.
Intervention model description
Both bi-variable and multivariable analyses using multilevel mixed effects modified Poisson models with random effects will be carried out if the outcome variable prevalence is greater than 20%. If the prevalence is less than 20%, a multilevel mixed effects binary logistic regression model will be utilized to adjust for between- and within-cluster variation for adjusted analysis.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Pregnant women less than 3 months of gestational age and residing in the district for at least 6 months.
Exclusion criteria
* Women who have a severe illness during the data collection period * Women who have a psychiatric disorder * Women who have plan to change residence during the implementation of an intervention * Women who have chronic diseases like tuberculosis, HIV/AIDS, and cancer * women who received blood transfusion in the last 6 months * Women who have had malaria at least 3 times in the last 3 months * Women with severe anemia (\<7 g/dl) detected during the survey
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of anemia | Up to six months | In pregnancy, anemia is defined as Hemoglobin \<11 g/dl and is classified into three categories based on WHO criteria: mild (10.0-10.9 g/dl), moderate (7.0-9.9 g/dl), and severe (7.0 g/dl) |
| Prevalence of under-nutrition | Up to six months | In this study, the MUAC measurements of pregnant mothers who fall below a cutoff point of 23 cm will be classified as undernourished, while those who measure 23 cm or more will be classified as normal. |
Contacts
Primary ContactEmbialle MI Beyene, PhD
Backup ContactAmanuel Ej Debiso, Masters
Outcome results
None listed