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CompletedNCT02791100Updated Oct 19, 2018

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

An interventional study of Promotion of chicken eggs in Thinness, Food Habits and Health Knowledge, Attitudes, Practices, sponsored by University of Saskatchewan. Completed at 1 site in Ethiopia. Open to participants aged 6 Months to 15 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-19.

Sponsored by University of Saskatchewan · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
287
Allocation
Randomized
Ages
6 Months to 15 Months
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Thinness
  • Food Habits
  • Health Knowledge, Attitudes, Practices

Keywords

  • height
  • weight
  • diet
  • complementary foods
  • protein
  • calcium
03

In context

Thinness

66 studies on the registry are indexed under Thinness; 11 are open to participants now.

This study's enrollment of 287 is close to the median of 287 across 43 interventional studies indexed under Thinness.

Browse Thinness studies →

Lead sponsor

University of Saskatchewan is the lead sponsor of 243 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 15 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • children undergoing treatment for malnutrition
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
287 participants (actual)

Study arms

  • No intervention
    No promotion of chicken eggs

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

  • 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.

    Behavioral: Promotion of chicken eggs

Interventions

  • BehavioralPromotion of chicken eggs

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

06

What researchers measure

Primary outcomes

  1. weight (kg)

    weight (kg) of child

    Time frame: 6 months

Secondary outcomes

  1. knowledge, attitudes and practices on egg and egg shell use via questionnaire

    Via questionnaire assess whether mothers have improved complementary feeding

    Time frame: 6 months

  2. health status as hemoglobin measure

    measure hemoglobin as measure of overall health status

    Time frame: 6 months

  3. incidence of reported infections in study children

    record number of reported infections

    Time frame: 6 months

07

Study locations

1 site
  • Hawassa University School of Nutrition, Food Science
    Hawassa, Ethiopia
08

References and documents

Publications

  • 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. PubMed 23607686 ↗
  • 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. PubMed 21247015 ↗
  • 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. PubMed 20156903 ↗
  • 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. PubMed 25639132 ↗
  • 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.

Individual participant data

Plan to share: No — Only group data, means, median

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2016 to primary completion in Dec 2016, 6 months.

Of 22 interventional studies with no phase under Thinness, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 30. This study's 6 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 21, 2015
First posted
Jun 6, 2016
StartActual
May 25, 2016
Primary completionActual
Dec 22, 2016
CompletionActual
Dec 22, 2016
Last update
Oct 19, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02791100
Collaborators
Hawassa University
Responsible party
Susan Whiting (Ph.D., University of Saskatchewan) — Principal investigator
First posted
Jun 6, 2016
Start date
May 25, 2016
Primary completion
Dec 22, 2016
Completion
Dec 22, 2016
Last update
Oct 19, 2018

Study contacts

Susan J Whiting, PhD
principal investigator · University of Saskatchewan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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