Malnutrition, ChildNCT02516852
Assessing the Effect of Sustainable Small-scale Egg Production on Maternal and Child Nutrition in Rural Zambia
A study testing Egg production in people with Malnutrition, Child and Malnutrition, Infant, run by Cornell University at 1 site in Zambia.
Trial summary
Animal source foods (ASF), such as meat and eggs, are rich in nutrients critical for growth and development. Yet, for poor children in developing countries, ASF consumption is limited by cost, inadequate caregiver knowledge, and lack of local production and physical availability. Read more about this study
- Who is it for?
- Ages 6 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition, Child, Malnutrition, Infant
- What is being tested?
- Egg production
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,546 participants
- Where
- 1 siteZambia
- Study dates
- Jun 2014to May 2017
- 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 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- the HH dwelling is ≤1.5 km from the egg production facility or central control point;
- there is a child 6-36 months of age in the HH; and,
- Additionally, all HHs that include a member of the egg production group will be enrolled in the study, regardless of whether or not they meet the above inclusion criteria.
Who cannot join
- the mother/primary caretaker or head of HH cannot converse with the field staff because of language;
- the mother/primary caretaker or head of HH is unable to give informed consent or complete an interview without assistance; or,
- the child is deformed, disabled, severely ill, or unable to cooperate for anthropometric measures.
Trial locations and contacts
1 site in 1 country.
About this study
Animal source foods (ASF), such as meat and eggs, are rich in nutrients critical for growth and development. Yet, for poor children in developing countries, ASF consumption is limited by cost, inadequate caregiver knowledge, and lack of local production and physical availability. The impact of HH- and village-level livestock interventions on household dietary diversity and nutritional status in resource-poor communities is not well established. The objective of this study is to test the effectiveness of local egg production intervention on maternal and child diets and child nutrition status.
This project takes place in the Luangwa Valley, Zambia in partnership with a local non-governmental organization, COMACO. Twenty communities will be assigned to the intervention, and 20 matched communities will be selected as controls. In each intervention community, an egg production facility will be built, owned, and operated by trained COMACO farmers.
Households (HHs) in each community will be sampled twice annually for 1 year pre-intervention (baseline) and 1 year post-intervention to assess dietary diversity and nutritional status. Data analysis will test for a change in these outcomes from baseline in each intervention community compared to the matched control community.
Read the detailed description
The objective of this study is to test the effectiveness of an intervention establishing local egg production on maternal and child diets and nutrition status. The investigators hypothesize that this intervention, combined with appropriate agricultural extension and nutrition education programs, will result in: 1) increased total household, maternal, and child consumption of eggs; 2) improved maternal and child dietary quality; and 3) improved infant/ young child nutritional status.
The investigators will test this hypothesis in the Luangwa Valley, Zambia in partnership with a local non-governmental organization, Community Markets for Conservation (COMACO). The forty study sites are located in four geographic clusters (Chiefdoms) in Eastern Province Zambia. These Chiefdoms are located in two districts: Mambwe (Mnkhanya, Jumbe, and Nsefu Chiefdoms) and Lundazi (Mwanya Chiefdom).
Twenty communities will be assigned to the intervention (egg production), and 20 matched communities will be selected as controls (no intervention). In each intervention community, an egg production facility will be built, each owned and operated by trained COMACO farmers, mostly women. Each group will be provided layer pullets at point-of-lay and layer mash. Facility owners will make all business decisions, retain all profits, and will be responsible for all upkeep costs.
In a repeated cross-sectional study design, indicators of food security, wealth, diet, nutritional status (anthropometrics), and health and wellbeing will be assessed in all egg-producing HHs and in women/child dyads (children aged 6-36 months) residing in the area surrounding each facility or central control point. Data will be collected twice annually for 1 year pre-intervention (baseline) and 1 year post-intervention.
The exposure of interest is living in an egg-producing community. In the primary analysis, the investigators will use hierarchical mixed effects modeling to analyze the effect of the program on each of the outcomes of interest (see Outcome Measures section for details).
- Conditions
- Malnutrition, Child, Malnutrition, Infant
- Being tested
- Egg production
- Keywords
- community development; poultry; animal-source food; stunting
- Medical subject headings
- Child Nutrition Disorders, Infant Nutrition Disorders, Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Egg productionOther
Establishment and support of a community-owned and -operated egg production facility located at a central location in the community
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Other: Egg production |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in child height-for-age Z-score
Recumbent length for children < 24 months and standing height for those 24-36 months, with WHO Child Growth Standards as the reference population.
Measured: 6, 12, 18, and 24 months after intervention
Secondary outcomes (6)
Change in household egg consumption
7 day recall on total number of chicken or other eggs consumed in the household
Measured: 6, 12, 18, and 24 months after intervention
Change in maternal egg consumption
Measured: 6, 12, 18, and 24 months after intervention
Change in child egg consumption
Measured: 6, 12, 18, and 24 months after intervention
Change in maternal dietary diversity
Measured by Women's Dietary Diversity Score, a 24 hour recall of all foods consumed, organized into 9 food groups
Measured: 6, 12, 18, and 24 months after intervention
Change in child dietary diversity
Measured: 6, 12, 18, and 24 months after intervention
Change in child stunting
Defined as having a height-for-age z-score < -2.0, with WHO Growth Standards as the reference population.
Measured: 6, 12, 18, and 24 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2015 (estimated)
- Study startJun 2014
- Primary completionJul 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnutrition, ChildStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,546 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Community Markets for Conservation (COMACO)
- Responsible party
- Sponsor
- Investigators
- Alexander J Travis, VMD, PhD, Principal investigator, Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02516852
- Sponsor's protocol ID
- 1402004456
- Status last verified
- Feb 2018
- First submitted
- 3 Aug 2015
- Last updated
- 6 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effect of Sustainable Small-scale Egg Production on Maternal and Child Nutrition in Rural Zambia
- ClinicalTrials.gov ID
- NCT02516852
- Acronym / sponsor ID
- 1402004456
- Conditions
- Malnutrition, Child, Malnutrition, Infant
- Keywords
- community development; poultry; animal-source food; stunting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,546 participants (actual)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Collaborators
- Community Markets for Conservation (COMACO)
- Study start
- Jun 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 6 Aug 2015 (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.
Animal source foods (ASF), such as meat and eggs, are rich in nutrients critical for growth and development. Yet, for poor children in developing countries, ASF consumption is limited by cost, inadequate caregiver knowledge, and lack of local production and physical availability. The impact of HH- and village-level livestock interventions on household dietary diversity and nutritional status in resource-poor communities is not well established. The objective of this study is to test the effectiveness of local egg production intervention on maternal and child diets and child nutrition status.
This project takes place in the Luangwa Valley, Zambia in partnership with a local non-governmental organization, COMACO. Twenty communities will be assigned to the intervention, and 20 matched communities will be selected as controls. In each intervention community, an egg production facility will be built, owned, and operated by trained COMACO farmers.
Households (HHs) in each community will be sampled twice annually for 1 year pre-intervention (baseline) and 1 year post-intervention to assess dietary diversity and nutritional status. Data analysis will test for a change in these outcomes from baseline in each intervention community compared to the matched control community.
Detailed description
The objective of this study is to test the effectiveness of an intervention establishing local egg production on maternal and child diets and nutrition status. The investigators hypothesize that this intervention, combined with appropriate agricultural extension and nutrition education programs, will result in: 1) increased total household, maternal, and child consumption of eggs; 2) improved maternal and child dietary quality; and 3) improved infant/ young child nutritional status.
The investigators will test this hypothesis in the Luangwa Valley, Zambia in partnership with a local non-governmental organization, Community Markets for Conservation (COMACO). The forty study sites are located in four geographic clusters (Chiefdoms) in Eastern Province Zambia. These Chiefdoms are located in two districts: Mambwe (Mnkhanya, Jumbe, and Nsefu Chiefdoms) and Lundazi (Mwanya Chiefdom).
Twenty communities will be assigned to the intervention (egg production), and 20 matched communities will be selected as controls (no intervention). In each intervention community, an egg production facility will be built, each owned and operated by trained COMACO farmers, mostly women. Each group will be provided layer pullets at point-of-lay and layer mash. Facility owners will make all business decisions, retain all profits, and will be responsible for all upkeep costs.
In a repeated cross-sectional study design, indicators of food security, wealth, diet, nutritional status (anthropometrics), and health and wellbeing will be assessed in all egg-producing HHs and in women/child dyads (children aged 6-36 months) residing in the area surrounding each facility or central control point. Data will be collected twice annually for 1 year pre-intervention (baseline) and 1 year post-intervention.
The exposure of interest is living in an egg-producing community. In the primary analysis, the investigators will use hierarchical mixed effects modeling to analyze the effect of the program on each of the outcomes of interest (see Outcome Measures section for details).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Egg production |
| Control | No intervention | – |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- the HH dwelling is ≤1.5 km from the egg production facility or central control point;
- there is a child 6-36 months of age in the HH; and,
- Additionally, all HHs that include a member of the egg production group will be enrolled in the study, regardless of whether or not they meet the above inclusion criteria.
Key exclusion criteria (3 listed)
- the mother/primary caretaker or head of HH cannot converse with the field staff because of language;
- the mother/primary caretaker or head of HH is unable to give informed consent or complete an interview without assistance; or,
- the child is deformed, disabled, severely ill, or unable to cooperate for anthropometric measures.
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 |
|---|---|---|
| Egg productionEstablishment and support of a community-owned and -operated egg production facility located at a central location in the community | Other | Intervention |
Primary outcome
Change in child height-for-age Z-score
Time frame: 6, 12, 18, and 24 months after intervention
Recumbent length for children < 24 months and standing height for those 24-36 months, with WHO Child Growth Standards as the reference population.
6 secondary outcomes
Change in household egg consumption
Time frame: 6, 12, 18, and 24 months after intervention
Change in maternal egg consumption
Time frame: 6, 12, 18, and 24 months after intervention
Change in child egg consumption
Time frame: 6, 12, 18, and 24 months after intervention
Change in maternal dietary diversity
Time frame: 6, 12, 18, and 24 months after intervention
Change in child dietary diversity
Time frame: 6, 12, 18, and 24 months after intervention
Change in child stunting
Time frame: 6, 12, 18, and 24 months after intervention
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 6 Feb 2018.
- Community Markets for Conservation (COMACO) official websiteLink provided by the sponsor.
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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.
Alexander J Travis, VMD, PhD principal investigator
Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Egg production in people with Malnutrition, Child and Malnutrition, Infant, run by Cornell University at 1 site in Zambia.
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 3 inclusion and 3 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 6 Feb 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 Zambia. 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?
Change in child height-for-age Z-score (time frame: 6, 12, 18, and 24 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2018.