Egg ConsumptionNCT05062382
Complementary Feeding Project in Ethiopia
A study testing Complementary feeding intervention in people with Egg Consumption, run by University of South Carolina at 1 site in Ethiopia.
Trial summary
The Global Alliance for Improved Nutrition (GAIN), a Swiss-based foundation, implemented a complementary feeding project to improve dietary quality among children 6-59 months of age living in Ethiopia by improving demand and access to eggs. Read more about this study
- Who is it for?
- Ages 6 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Egg Consumption
- What is being tested?
- Complementary feeding intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,132 participants
- Where
- 1 siteEthiopia
- Study dates
- 1 Sep 2019to 1 Jul 2021
- 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 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Living in the project areas
- Caregiver 18 years old or above
Who cannot join
- households without children between the ages of 6-59 months
Trial locations and contacts
1 site in 1 country.
About this study
The Global Alliance for Improved Nutrition (GAIN), a Swiss-based foundation, implemented a complementary feeding project to improve dietary quality among children 6-59 months of age living in Ethiopia by improving demand and access to eggs. Using a quasi-experimental design and two separate cross-sectional surveys at baseline and end-line, the evaluation seeks to determine the effects of the program on egg consumption, availability of eggs, caregivers' behaviours toward eggs, and caregivers' willingness to pay for eggs.
Read the detailed description
The Global Alliance for Improved Nutrition (GAIN), a Swiss-based foundation, implemented a complementary feeding project to improve dietary quality among children 6-59 months of age living in Ethiopia by improving demand and access to eggs. The complementary feeding project aimed to boost children's consumption of eggs. The intervention incorporated demand creation campaigns and supported selected delivery channels and producers who provided eggs to communities. GAIN's demand creation strategy was designed to complement the Ethiopian government's effort to use social and behavior change communication to encourage consumption of nutritious complementary foods. This campaign was implemented through the existing health extension system.
Areas included in the intervention arm received direct support for egg producers and suppliers and an egg demand creation campaign. Supply-side interventions included training for farmers, identification of distribution channels, mapping of retailers, and creation of linkages between egg producers and egg suppliers. Egg demand-creation activities were executed through above-the-line (ATL) and below-the-line (BTL) campaigns. The ATL campaigns included radio messages, bajaja branding, billboard mounting, and digital promotion. The BTL campaigns include market activation, road shows, sensitization workshops for key community groups, door-to-door promotion, and mobile promotion in collaboration with creative agencies and health extension workers. Both sets of activities focused on creating awareness around eggs as a daily nutritious food option for children.
Originally, the study intended to also increase availability of, and demand for, commercially-available complementary foods (i.e., Cerifam and Fafa), however, these components of the intervention were not delivered. Therefore, we have removed these components from the description and removed the outcomes that corresponded with these components of the intervention.
Using a quasi-experimental design and two separate cross-sectional surveys at baseline and end-line, the evaluation seeks to determine the effects of the program on egg consumption, availability of eggs, caregivers' behaviours toward eggs, and caregivers' willingness to pay for eggs.
- Conditions
- Egg Consumption
- Being tested
- Complementary feeding intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complementary feeding interventionBehavioural
The study promoted eggs.
GAIN provided training to egg farmers to increase their egg production and marketing, helped increase mother's access to eggs by making them more available in local kiosks and getting retailers to display promotional messages around eggs, conducted sensitization workshops with retailers to increase egg purchases, and employed a demand creation campaign.
| Study group | Role | What they receive |
|---|---|---|
| Complementary feeding program | Experimental | Promotion of eggs. Receives: Behavioral: Complementary feeding intervention |
| Comparison | No intervention | Comparison arm with no program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of eggs consumed from baseline to end-line
Change in the average number of eggs consumed in the past 7 days by children 6 to 59 months of age from baseline to end-line in the two study arms
Measured: From baseline to 22 months
Change in the consumption of eggs from baseline to end-line
Change in the proportion of children 6-59 months of age consuming eggs in the last 7 days and in the last 24 hours from baseline to end-line in the two study arms
Measured: From baseline to 22 months
Secondary outcomes (4)
Change in household egg production from baseline to end-line
Change in the proportion of households producing eggs from baseline to end-line in the two study arms
Measured: From baseline to 22 months
Change in egg purchasing from baseline to end-line
Change in the proportion of households that purchased egg in the last month from baseline to end-line in the two study arms
Measured: From baseline to 22 months
Change in caregivers' (of children 6-59 months) behavioral determinants in the context of feeding eggs to children from baseline to end-line
Change in the mean factor score created from Likert scales of attitudes (attitudes scale, higher score reflects better attitudes towards eggs), norms (norms scale, higher score reflects better norms towards eggs), self-efficacy (self-efficacy scale, higher score reflects better self-efficacy), and intention towards eggs (intent to feed eggs to child, higher score reflects more intent to feed eggs) from baseline to end-line between the two study arms; change will be examined for a meta factor score combining all scales and each scale separately. Values of factor scores are unbounded and can be positive or negative.
Measured: From baseline to 22 months
Change in caregivers' willingness to pay for eggs from baseline to end-line
Change in willingness to pay for eggs, using for example the change in mean maximum price that caregivers would be willing to pay for eggs from baseline to endline between the two study arms.
Measured: From baseline to 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start1 Sep 2019
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Cross-sectional pre- post-evaluation of intervention and comparison group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Global Alliance for Improved Nutrition
- Responsible party
- Principal investigator, Edward Frongillo, Jr., University of South Carolina
- Investigators
- Edward A Frongillo, PhD, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05062382
- Sponsor's protocol ID
- 102
- Status last verified
- Aug 2022
- First submitted
- 21 Sep 2021
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Reports will be made available. We will provide information on how to make the request to have access to the partial or complete anonymized dataset.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complementary Feeding Project in Ethiopia
- ClinicalTrials.gov ID
- NCT05062382
- Acronym / sponsor ID
- 102
- Conditions
- Egg Consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,132 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- Global Alliance for Improved Nutrition
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 30 Sep 2021 (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), a Swiss-based foundation, implemented a complementary feeding project to improve dietary quality among children 6-59 months of age living in Ethiopia by improving demand and access to eggs. Using a quasi-experimental design and two separate cross-sectional surveys at baseline and end-line, the evaluation seeks to determine the effects of the program on egg consumption, availability of eggs, caregivers' behaviours toward eggs, and caregivers' willingness to pay for eggs.
Detailed description
The Global Alliance for Improved Nutrition (GAIN), a Swiss-based foundation, implemented a complementary feeding project to improve dietary quality among children 6-59 months of age living in Ethiopia by improving demand and access to eggs. The complementary feeding project aimed to boost children's consumption of eggs. The intervention incorporated demand creation campaigns and supported selected delivery channels and producers who provided eggs to communities. GAIN's demand creation strategy was designed to complement the Ethiopian government's effort to use social and behavior change communication to encourage consumption of nutritious complementary foods. This campaign was implemented through the existing health extension system.
Areas included in the intervention arm received direct support for egg producers and suppliers and an egg demand creation campaign. Supply-side interventions included training for farmers, identification of distribution channels, mapping of retailers, and creation of linkages between egg producers and egg suppliers. Egg demand-creation activities were executed through above-the-line (ATL) and below-the-line (BTL) campaigns. The ATL campaigns included radio messages, bajaja branding, billboard mounting, and digital promotion. The BTL campaigns include market activation, road shows, sensitization workshops for key community groups, door-to-door promotion, and mobile promotion in collaboration with creative agencies and health extension workers. Both sets of activities focused on creating awareness around eggs as a daily nutritious food option for children.
Originally, the study intended to also increase availability of, and demand for, commercially-available complementary foods (i.e., Cerifam and Fafa), however, these components of the intervention were not delivered. Therefore, we have removed these components from the description and removed the outcomes that corresponded with these components of the intervention.
Using a quasi-experimental design and two separate cross-sectional surveys at baseline and end-line, the evaluation seeks to determine the effects of the program on egg consumption, availability of eggs, caregivers' behaviours toward eggs, and caregivers' willingness to pay for eggs.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cross-sectional pre- post-evaluation of intervention and comparison group
| Arm | Type | Receives |
|---|---|---|
| Complementary feeding program | Experimental | Behavioral: Complementary feeding interventionPromotion of eggs. |
| Comparison | No intervention | –Comparison arm with no program |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Living in the project areas
- Caregiver 18 years old or above
Key exclusion criteria (1 listed)
- households without children between the ages of 6-59 months
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 |
|---|---|---|
| Complementary feeding interventionThe study promoted eggs. GAIN provided training to egg farmers to increase their egg production and marketing, helped increase mother's access to eggs by making them more available in local kiosks and getting retailers to display promotional messages around eggs, conducted sensitization workshops with retailers to increase egg purchases, and employed a demand creation campaign. | Behavioural | Complementary feeding program |
Primary outcome
Change in the number of eggs consumed from baseline to end-line
Time frame: From baseline to 22 months
Change in the average number of eggs consumed in the past 7 days by children 6 to 59 months of age from baseline to end-line in the two study arms
Change in the consumption of eggs from baseline to end-line
Time frame: From baseline to 22 months
Change in the proportion of children 6-59 months of age consuming eggs in the last 7 days and in the last 24 hours from baseline to end-line in the two study arms
4 secondary outcomes
Change in household egg production from baseline to end-line
Time frame: From baseline to 22 months
Change in egg purchasing from baseline to end-line
Time frame: From baseline to 22 months
Change in caregivers' (of children 6-59 months) behavioral determinants in the context of feeding eggs to children from baseline to end-line
Time frame: From baseline to 22 months
Change in caregivers' willingness to pay for eggs from baseline to end-line
Time frame: From baseline to 22 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 4 Aug 2022.
- Individual participant dataSharing planned: Yes. Reports will be made available. We will provide information on how to make the request to have access to the partial or complete anonymized dataset.
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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.
Edward A Frongillo, PhD principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complementary feeding intervention in people with Egg Consumption, run by University of South Carolina 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 4 Aug 2022. 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?
Change in the number of eggs consumed from baseline to end-line (time frame: From baseline to 22 months). 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 4 Aug 2022.