Ignite Creation Date:
2024-05-06 @ 8:39 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02791100
Status:
COMPLETED
Last Update Posted:
2018-10-19
First Post:
2015-09-21
Brief Title:
Promotion of Egg and Eggshell Powder Consumption Improve Nutritional Status of Children in Halaba Ethiopia
Sponsor:
University of Saskatchewan
Organization:
University of Saskatchewan
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 14 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
Detailed Description:
Young children in Ethiopia lack sufficient protein and micronutrients for growth and developmentThe 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 childrens 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 meansthe 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 testanalysis techniques and reported accordingly P-value of less than 005 will be taken as significant
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 childrens 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 meansthe 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 testanalysis techniques and reported accordingly P-value of less than 005 will be taken as significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None