- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02791100
Promotion of Egg and Eggshell Powder Consumption Improve Nutritional Status of Children in Halaba Ethiopia
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
Study Overview
Status
Intervention / Treatment
Detailed Description
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hawassa, Ethiopia
- Hawassa University School of Nutrition, Food Science
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- not known to be allergic to eggs.
- not undergoing therapy for moderate or severe malnutrition.
Exclusion Criteria:
- children undergoing treatment for malnutrition
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: No promotion of chicken eggs
The community receives no chickens and therefore has no additional eggs or egg shell powder for children
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Experimental: Promotion of Chicken eggs for children
The community receives chickens so that each study child receives 2 eggs a day and also receives some egg shell daily (1/4 bottle cap which provides 500 mg Ca).
The community receives information on using the egg and eggshell, and has help in caring for the chickens.
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Community is provided with chickens and young children are to receive 2 eggs a day plus egg shell
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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weight (kg)
Time Frame: 6 months
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weight (kg) of child
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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knowledge, attitudes and practices on egg and egg shell use via questionnaire
Time Frame: 6 months
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Via questionnaire assess whether mothers have improved complementary feeding
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6 months
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health status as hemoglobin measure
Time Frame: 6 months
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measure hemoglobin as measure of overall health status
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6 months
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incidence of reported infections in study children
Time Frame: 6 months
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record number of reported infections
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6 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Susan J Whiting, PhD, University of Saskatchewan
Publications and helpful links
General Publications
- Negash C, Belachew T, Henry CJ, Kebebu A, Abegaz K, Whiting SJ. Nutrition education and introduction of broad bean-based complementary food improves knowledge and dietary practices of caregivers and nutritional status of their young children in Hula, Ethiopia. Food Nutr Bull. 2014 Dec;35(4):480-6. doi: 10.1177/156482651403500409.
- Brun LR, Lupo M, Delorenzi DA, Di Loreto VE, Rigalli A. Chicken eggshell as suitable calcium source at home. Int J Food Sci Nutr. 2013 Sep;64(6):740-3. doi: 10.3109/09637486.2013.787399. Epub 2013 Apr 22.
- Mukaratirwa S, Khumalo MP. Prevalence of helminth parasites in free-range chickens from selected rural communities in KwaZulu-Natal province of South Africa. J S Afr Vet Assoc. 2010 Jun;81(2):97-101. doi: 10.4102/jsava.v81i2.113.
- Victora CG, de Onis M, Hallal PC, Blossner M, Shrimpton R. Worldwide timing of growth faltering: revisiting implications for interventions. Pediatrics. 2010 Mar;125(3):e473-80. doi: 10.1542/peds.2009-1519. Epub 2010 Feb 15.
- Omer A, Mulualem D, Classen H, Vatanparast H, Whiting SJ (2018) Promotion of Egg and Eggshell Powder Consumption Improves Nutritional Status of Children of Under Two Years of Age: A Cluster Randomized Controlled Community Trial in Halaba Sp. Woreda, SNNPR Journal of Agricultural Science, 10(5), ISSN 1916-9752 E-ISSN 1916-9760.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HU-UoS-EGG
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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