ThinnessNCT02791100
Promotion of Egg and Eggshell Powder Consumption Improve Nutritional Status of Children in Halaba Ethiopia
A study testing Promotion of chicken eggs in people with Thinness and Food Habits, run by University of Saskatchewan at 1 site in Ethiopia.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 15 monthsHealthy volunteers can take part
- Conditions the study is for
- Thinness, Food Habits, Health Knowledge, Attitudes, Practices
- What is being tested?
- Promotion of chicken eggs
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 287 participants
- Where
- 1 siteEthiopia
- Study dates
- 25 May 2016to 22 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- not known to be allergic to eggs.
- not undergoing therapy for moderate or severe malnutrition.
Who cannot join
- children undergoing treatment for malnutrition
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
- Being tested
- Promotion of chicken eggs
- Keywords
- height, weight, diet, complementary foods, protein, calcium
- Medical subject headings
- Thinness, Feeding Behavior, Behavior, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promotion of chicken eggsBehavioural
Community is provided with chickens and young children are to receive 2 eggs a day plus egg shell
| Study group | Role | What they receive |
|---|---|---|
| No promotion of chicken eggs | No intervention | The community receives no chickens and therefore has no additional eggs or egg shell powder for children |
| Promotion of Chicken eggs for children | Experimental | 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. Receives: Behavioral: Promotion of chicken eggs |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight (kg)
weight (kg) of child
Measured: 6 months
Secondary outcomes (3)
knowledge, attitudes and practices on egg and egg shell use via questionnaire
Via questionnaire assess whether mothers have improved complementary feeding
Measured: 6 months
health status as hemoglobin measure
measure hemoglobin as measure of overall health status
Measured: 6 months
incidence of reported infections in study children
record number of reported infections
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study start25 May 2016
- Primary completion22 Dec 2016
- Study completion22 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ThinnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Hawassa University
- Responsible party
- Principal investigator, Susan Whiting, University of Saskatchewan
- Investigators
- Susan J Whiting, PhD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791100
- Sponsor's protocol ID
- HU-UoS-EGG
- Status last verified
- Oct 2018
- First submitted
- 21 Sep 2015
- Last updated
- 19 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Only group data, means, median
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 23607686Mukaratirwa 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 21247015Victora 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 20156903Negash 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 25639132Omer 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 at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02791100
- Acronym / sponsor ID
- HU-UoS-EGG
- Keywords
- height, weight, diet, complementary foods, protein, calcium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Hawassa University
- Study start
- 25 May 2016 (actual)
- Primary completion
- 22 Dec 2016 (actual)
- Study completion
- 22 Dec 2016 (actual)
- First posted
- 6 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No promotion of chicken eggs | No intervention | –The community receives no chickens and therefore has no additional eggs or egg shell powder for children |
| Promotion of Chicken eggs for children | Experimental | Behavioral: Promotion of chicken eggsThe 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. |
Who may qualify
- Ages
- 6 to 15 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- not known to be allergic to eggs.
- not undergoing therapy for moderate or severe malnutrition.
Key exclusion criteria (1 listed)
- children undergoing treatment for malnutrition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Promotion of chicken eggsCommunity is provided with chickens and young children are to receive 2 eggs a day plus egg shell | Behavioural | Promotion of Chicken eggs for children |
Primary outcome
weight (kg)
Time frame: 6 months
weight (kg) of child
3 secondary outcomes
knowledge, attitudes and practices on egg and egg shell use via questionnaire
Time frame: 6 months
health status as hemoglobin measure
Time frame: 6 months
incidence of reported infections in study children
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2018.
- Background: PubMed 23607686Brun 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.
- Background: PubMed 21247015Mukaratirwa 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.
- Background: PubMed 20156903Victora 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.
- Background: PubMed 25639132Negash 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.
- Results publicationOmer 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 dataSharing planned: No. Only group data, means, median
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan J Whiting, PhD principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Promotion of chicken eggs in people with Thinness and Food Habits, run by University of Saskatchewan at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight (kg) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02791100, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2018.