Food Habits Clinical Trial
Official title:
Promotion of Egg and Eggshell Powder Consumption Improve Nutritional Status of Children of Under Two Years of Age: A Cluster Randomized Controlled Community Trial in Halaba Ethiopia
Young children in Ethiopia lack sufficient protein and micronutrients for growth and development. The overall purpose is to assess the effects of promoting egg and eggshell powder consumption on improving the nutritional status of children 6 to 15 months in Halaba Special Woreda, Southern Ethiopia. The hypothesis is that providing chickens to produce eggs (egg and eggshell) for young children will improve growth in otherwise malnourished young children. Upon providing chickens, the nutritional status of young children prior and after the intervention (by 6 months) will be assessed. Identification of the knowledge, attitude and practices (KAP) of mothers on egg and eggshell powder consumption by their children before and after the intervention in the intervention group will be done. Caregivers will be instructed to give each child 1 egg (cooked) and 1/4 "bottle cap" of eggshell (500 mg calcium) per day in the intervention. Hemoglobin will be measured as an indicator of overall nutritional status. Throughout the study, any problems arising in keeping chickens will be recorded in order to assess the feasibility and practicality of raising chickens as way to improve nutritional status of young children. The study is novel in that investigators are providing a way to have increased protein, increased micronutrients, and use of eggshell as a source of calcium.
Young children in Ethiopia lack sufficient protein and micronutrients for growth and
development.The study will adopt a 6-month cluster-randomized and controlled trial design.
There will be a treatment group (communities receiving chickens) and a control group (no
chickens for the 6 months of the study).
Study participants will be recruited from all children aged between 6-15 months old, who are
residents of 6 Kebeles in the clusters. from these 6, the Control and Intervention areas will
be randomly selected. This age group is selected because it is the time of introduction of
complementary food and it will be easier to see the clear effect of egg on the children
growth, rather than choosing older children.
In the Intervention group, children who are known to be allergic to egg will be excluded from
the study. The following measurements will be made at baseline (prior to chicken ceremony in
intervention areas) and at month 6: dietary assessment by 24-hour recall of child and mother;
food frequency questionnaire for diet diversity score; hemoglobin test (involving a single
finger prick) of child; weight and height (or for very young children, length); knowledge and
attitude questions on egg and egg-shell nutrition. At baseline only, caregivers will answer
demographic questions. Monthly, there will be monitoring of egg and eggshell consumption by
children as well as measurement of height (length), and a structured questionnaire on
morbidity. In the intervention group, caregivers will be instructed to provide one egg and a
small amount of eggshell (providing 500 mg calcium). At 9 month, the research assistant will
visit the Intervention communities to informally gather data on chickens being used,
participant children's health status (any follow-up morbidity data). Throughout data will be
collected on infection rate, with the possibility of improvement due to better nutrition but
also awareness that bringing chickens into the community could pose a risk to very young
children. As well, there will be formal follow-up observation at one community site with
focus group discussion and key informant interviews, as a way to assess feasibility and
practically of chicken donation in the future. This will be a convenience sample representing
participant parents, community leaders, Agriculture Extension workers, Health extension
workers, persons who were not directly involved. Those targeted for interviews will be the
extension workers from whom feedback will be provided, while focus groups will be held with
others who are able to attend a focus group session .
Data checks will be provided by the MSc student and his local supervisor who planned the
study but is not directly involved in day-to-day running of the intervention. The student
will write SOPs for all procedures. Missing data will be accounted for but as this is a
community based study group means will be used for most outcome measurements. Comparing of
two means/the differences of means between the intervention and control groups will be done
using independent two sample t-test. Continuous outcomes will be analyzed using paired
t-test. Bivariate analysis will be used to see the overall effect of independent variables
and then further multivariate analysis (multiple linear regressions) will be done to see the
effect of each independent variable. Both crude and adjusted risk ratio with 95% confidence
interval will be reported. Other variables and relevant findings will be also analyzed using
proper statistical test/analysis techniques and reported accordingly. P-value of less than
0.05 will be taken as significant
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