Egg ConsumptionNCT05953753
Enhancing Access to Safe and Nutritious Diets (ENSAND) Evaluation Nigeria
A study testing Food system and demand generation in people with Egg Consumption, run by RTI International at 1 site in Nigeria.
Trial summary
The Global Alliance for Improved Nutrition (GAIN) is implementing a program in 4 countries to increase consumption of healthy foods by improving supply, increasing demand, and improving the enabling environment for different targeted foods by operating at multiple levels - individuals, households, markets, producers… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Egg Consumption
- What is being tested?
- Food system and demand generation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,625 participants
- Where
- 1 siteNigeria
- Study dates
- 9 Oct 2023to 6 Feb 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult caregiver who will be interviewed is 18 years or older;
- The household has a child in public primary school class 1-3 aged 6 - 9 years AND has a child 6-59 months
- The household earns <$3.20 per person per day;
- Able to speak English or Hausa;
- Provide informed consent to participate in the study.
- Egg Value Chain Interviews
Show all 15Show fewer
- Be a PAN state manager, national or state HGSFP manager, poultry farmer, school-level HGSFP manager, health teacher, or egg retailer or wholesaler in the local government areas selected for the evaluation;
- Be 18 years or older;
- Able to speak English or Hausa;
- Provide informed consent to participate in the study.
- Focus Group Discussions with Caregivers
- Caregivers with a child in class 1-3 and a child 6-59 months;
- Be 18 years or older;
- Able to speak English or Hausa;
- Provide informed consent to participate in the study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact and Process Evaluation of the Global Alliance for Improved Nutrition (GAIN) Enhancing Access to Safe and Nutritious Diets (ENSAND) Program in Nigeria
The Global Alliance for Improved Nutrition (GAIN) is implementing a program in 4 countries to increase consumption of healthy foods by improving supply, increasing demand, and improving the enabling environment for different targeted foods by operating at multiple levels - individuals, households, markets, producers, and policies. In Nigeria, the program is called Enhancing Access to Safe and Nutritious Diets (ENSAND). RTI and local partners propose to conduct impact and process evaluations of GAIN's program tailored to the theory of change and the target food for Nigeria. The evaluation in Nigeria will include a mix of quantitative and qualitative methods and will be guided by the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) evaluation framework.
Read the detailed description
ENSAND seeks to increase the frequency of egg consumption among students in classes 1-3 in public primary schools and their younger siblings aged 6-59 months in local government areas (LGAs) with a high proportion of bottom of the pyramid (BoP) households. GAIN's intervention is two-pronged in Kaduna State. One component will involve improving the egg value chain supplying the Home-Grown School Feeding Program (HGSFP) for primary school children and the other will involve using a social marketing approach to increase parents' willingness to purchase and feed eggs to their young children aged 6-59 months. In Federal Capital Territory (FCT) and Kebbi States, GAIN's intervention will focus only on supplying eggs to primary school children.
This evaluation of the ENSAND program will use a parallel group mixed-methods quasi-experimental before-after design to assess the effectiveness of the intervention on children's frequency of egg consumption in Kaduna (intervention) and Kano (control) States. The evaluation will be carried out in 3 intervention and 3 control LGAs, with clustering at the level of the school. Data will be collected through household surveys with caregivers and school-aged children (N=1,332 at baseline and endline), egg value chain actor key informant interviews (KIIs, N=3) and semi-structured interviews (N=191) at baseline, midline, and endline, and focus group discussions (FGDs, N=9 FGDs at midline and endline) with caregivers of young children. Households with school- and pre-school aged children will be identified through the sampled public primary schools, and caregivers and school-aged children will be interviewed at baseline and endline in intervention and control LGAs. The same schools will be used at both times points but cross-sectional samples will be drawn at baseline and endline. Egg value chain actors will be identified in the intervention LGAs in Kaduna to participate in KIIs and semi-structured interviews at baseline, midline, and endline to assess changes in the functioning of the value chain over time. FGDs with caregivers of young children will be conducted at midline and endline. The qualitative findings will be used to understand experiences with the interventions and findings will be triangulated with results from the household and egg value chain interviews.
In FCT and Kebbi, the evaluation will be limited to KIIs (N=4) and semi-structured interviews (N=102) with egg value chain actors at baseline, midline, and endline. The findings will be used to validate and triangulate with the monitoring data GAIN will be collecting from value chain actors.
- Conditions
- Egg Consumption
- Being tested
- Food system and demand generation
- Keywords
- diet, eggs, market intervention, social and behavior change communication intervention, infants, children, Nigeria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food system and demand generationBehavioural
The project is focused on improving egg consumption through enhanced availability, accessibility, and improved demand. To achieve this goal, the project intervention mix will work through three pathways: access, enabling environment, and demand. The access pathway aims to sustain availability and consumption of eggs by school children (age 6-9 years) from BoP households through interventions targeted at the Poultry Association of Nigeria (PAN) and state lead egg aggregators for the HGSFP. The enabling environment pathway focuses on the broader institutional, governance, and political factors to support accessibility, availability, improved consumption, and increased consumer demand for eggs. The demand pathway will be addressed by mass media and interpersonal communication to increase the willingness and motivation of parents/caregivers in BoP households to support and sustain egg consumption by pre-school children in Kaduna State.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Not described Receives: Behavioral: Food system and demand generation |
| Control/No intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of egg consumption by primary school children
Change in the mean frequency of egg consumption during the last 7 days by children in primary school classes 1-3 in BoP households
Measured: Baseline (August 2023), Endline (August 2026) (3 years)
Frequency of egg consumption by pre-school children
Change in the mean frequency of egg consumption during the last 7 days by children 6-59 months in BoP households
Measured: Baseline (August 2023), Endline (August 2026) (3 years)
Secondary outcomes (2)
Frequency of egg purchase
Change in frequency of eggs purchased for children
Measured: Baseline (August 2023), Endline (August 2026) (3 years)
Number of eggs purchased
Change in number of eggs purchased for children
Measured: Baseline (August 2023), Endline (August 2026) (3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start9 Oct 2023
- Primary completion6 Nov 2023
- Study completion6 Feb 2025
Why it stopped: The ENSAND project has been modified to focus on vegetable consumption in smallholder farmer households rather than egg consumption among children. The revisions are substantial enough to warrant closing this record and creating a new record.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Egg ConsumptionStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Model description
- Data will be collected through household surveys, value chain actor semi-structured interviews, KIIs, and FGDs. The protocol team has selected a subset of the intervention local government areas for the evaluation and identified an equal number of local government areas outside the program coverage area with similar characteristics to serve as the control.
- Masking
- None (open label)
- Enrolment
- 1,625 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- Datametrics Associates Ltd, University of Nigeria Nsukka, University of Abuja
- Responsible party
- Principal investigator, Valerie Flax, RTI International
- Investigators
- Abiodun F Ipadeola, Principal investigator, Datametrics Associates Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953753
- Sponsor's protocol ID
- 424602
- Status last verified
- Feb 2025
- First submitted
- 14 Jun 2023
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Dataset will be shared through Nesstar.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact and Process Evaluation of the Global Alliance for Improved Nutrition (GAIN) Enhancing Access to Safe and Nutritious Diets (ENSAND) Program in Nigeria
- ClinicalTrials.gov ID
- NCT05953753
- Acronym / sponsor ID
- 424602
- Conditions
- Egg Consumption
- Keywords
- diet, eggs, market intervention, social and behavior change communication intervention, infants, children, Nigeria
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The ENSAND project has been modified to focus on vegetable consumption in smallholder farmer households rather than egg consumption among children. The revisions are substantial enough to warrant closing this record and creating a new record.
- Enrolment
- 1,625 participants (actual)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- Datametrics Associates Ltd, University of Nigeria Nsukka, University of Abuja
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 6 Nov 2023 (actual)
- Study completion
- 6 Feb 2025 (actual)
- First posted
- 20 Jul 2023 (actual)
- 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.
The Global Alliance for Improved Nutrition (GAIN) is implementing a program in 4 countries to increase consumption of healthy foods by improving supply, increasing demand, and improving the enabling environment for different targeted foods by operating at multiple levels - individuals, households, markets, producers, and policies. In Nigeria, the program is called Enhancing Access to Safe and Nutritious Diets (ENSAND). RTI and local partners propose to conduct impact and process evaluations of GAIN's program tailored to the theory of change and the target food for Nigeria. The evaluation in Nigeria will include a mix of quantitative and qualitative methods and will be guided by the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) evaluation framework.
Detailed description
ENSAND seeks to increase the frequency of egg consumption among students in classes 1-3 in public primary schools and their younger siblings aged 6-59 months in local government areas (LGAs) with a high proportion of bottom of the pyramid (BoP) households. GAIN's intervention is two-pronged in Kaduna State. One component will involve improving the egg value chain supplying the Home-Grown School Feeding Program (HGSFP) for primary school children and the other will involve using a social marketing approach to increase parents' willingness to purchase and feed eggs to their young children aged 6-59 months. In Federal Capital Territory (FCT) and Kebbi States, GAIN's intervention will focus only on supplying eggs to primary school children.
This evaluation of the ENSAND program will use a parallel group mixed-methods quasi-experimental before-after design to assess the effectiveness of the intervention on children's frequency of egg consumption in Kaduna (intervention) and Kano (control) States. The evaluation will be carried out in 3 intervention and 3 control LGAs, with clustering at the level of the school. Data will be collected through household surveys with caregivers and school-aged children (N=1,332 at baseline and endline), egg value chain actor key informant interviews (KIIs, N=3) and semi-structured interviews (N=191) at baseline, midline, and endline, and focus group discussions (FGDs, N=9 FGDs at midline and endline) with caregivers of young children. Households with school- and pre-school aged children will be identified through the sampled public primary schools, and caregivers and school-aged children will be interviewed at baseline and endline in intervention and control LGAs. The same schools will be used at both times points but cross-sectional samples will be drawn at baseline and endline. Egg value chain actors will be identified in the intervention LGAs in Kaduna to participate in KIIs and semi-structured interviews at baseline, midline, and endline to assess changes in the functioning of the value chain over time. FGDs with caregivers of young children will be conducted at midline and endline. The qualitative findings will be used to understand experiences with the interventions and findings will be triangulated with results from the household and egg value chain interviews.
In FCT and Kebbi, the evaluation will be limited to KIIs (N=4) and semi-structured interviews (N=102) with egg value chain actors at baseline, midline, and endline. The findings will be used to validate and triangulate with the monitoring data GAIN will be collecting from value chain actors.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Data will be collected through household surveys, value chain actor semi-structured interviews, KIIs, and FGDs. The protocol team has selected a subset of the intervention local government areas for the evaluation and identified an equal number of local government areas outside the program coverage area with similar characteristics to serve as the control.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: Food system and demand generation |
| Control/No intervention | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Adult caregiver who will be interviewed is 18 years or older;
- The household has a child in public primary school class 1-3 aged 6 - 9 years AND has a child 6-59 months
- The household earns <$3.20 per person per day;
- Able to speak English or Hausa;
- Provide informed consent to participate in the study.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Food system and demand generationThe project is focused on improving egg consumption through enhanced availability, accessibility, and improved demand. To achieve this goal, the project intervention mix will work through three pathways: access, enabling environment, and demand. The access pathway aims to sustain availability and consumption of eggs by school children (age 6-9 years) from BoP households through interventions targeted at the Poultry Association of Nigeria (PAN) and state lead egg aggregators for the HGSFP. The enabling environment pathway focuses on the broader institutional, governance, and political factors to support accessibility, availability, improved consumption, and increased consumer demand for eggs. The demand pathway will be addressed by mass media and interpersonal communication to increase the willingness and motivation of parents/caregivers in BoP households to support and sustain egg consumption by pre-school children in Kaduna State. | Behavioural | Intervention |
Primary outcome
Frequency of egg consumption by primary school children
Time frame: Baseline (August 2023), Endline (August 2026) (3 years)
Change in the mean frequency of egg consumption during the last 7 days by children in primary school classes 1-3 in BoP households
Frequency of egg consumption by pre-school children
Time frame: Baseline (August 2023), Endline (August 2026) (3 years)
Change in the mean frequency of egg consumption during the last 7 days by children 6-59 months in BoP households
2 secondary outcomes
Frequency of egg purchase
Time frame: Baseline (August 2023), Endline (August 2026) (3 years)
Number of eggs purchased
Time frame: Baseline (August 2023), Endline (August 2026) (3 years)
Results and safety
The study was stopped early (reason given: The ENSAND project has been modified to focus on vegetable consumption in smallholder farmer households rather than egg consumption among children. The revisions are substantial enough to warrant closing this record and creating a new record.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: Yes. Dataset will be shared through Nesstar.
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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.
Abiodun F Ipadeola principal investigator
Datametrics Associates Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food system and demand generation in people with Egg Consumption, run by RTI International at 1 site in Nigeria.
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 15 inclusion and 0 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: stopped early, as of the sponsor's last update on 9 Apr 2025. 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 Nigeria. 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 was stopped early (reason given: The ENSAND project has been modified to focus on vegetable consumption in smallholder farmer households rather than egg consumption among children. The revisions are substantial enough to warrant closing this record and creating a new record.). Results are not available in the source record.
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?
Frequency of egg consumption by primary school children (time frame: Baseline (August 2023), Endline (August 2026) (3 years)). The study lists 2 primary outcomes in all. 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 9 Apr 2025.