Promotion of Egg and Eggshell Powder Consumption Improve Nutritional Status of Children in Halaba Ethiopia

NCT ID: NCT02791100

Last Updated: 2018-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 287 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-25
• Study Completion Date: 2016-12-22

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 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.

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

Conditions

Thinness; Food Habits; Health Knowledge, Attitudes, Practices

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

No promotion of chicken eggs

The community receives no chickens and therefore has no additional eggs or egg shell powder for children

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Promotion of chicken eggs

Intervention Type: BEHAVIORAL

Community is provided with chickens and young children are to receive 2 eggs a day plus egg shell

Interventions

Promotion of chicken eggs

Community is provided with chickens and young children are to receive 2 eggs a day plus egg shell

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• not known to be allergic to eggs.
• not undergoing therapy for moderate or severe malnutrition.

Exclusion Criteria

• children undergoing treatment for malnutrition

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 15 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hawassa University

OTHER

Sponsor Role: collaborator

University of Saskatchewan

OTHER

Sponsor Role: lead

Responsible Party

Susan Whiting

Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan J Whiting, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan

Locations

Hawassa University School of Nutrition, Food Science

Awasa, , Ethiopia

Countries

Ethiopia

References

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.

Reference Type: BACKGROUND

PMID: 23607686 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21247015 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20156903 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25639132 (View on PubMed)

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.

Reference Type: RESULT

Other Identifiers

HU-UoS-EGG

Identifier Type: -

Identifier Source: org_study_id