Egg ConsumptionNCT04937218
Impact Evaluation of GAIN Egg Campaign in Two Nigerian States
A study testing Egg demand creation campaign in people with Egg Consumption, run by University of South Carolina at 1 site in Nigeria.
Trial summary
Improved infant and young child feeding, including dietary quality and diversity, is important for child health and development. In the 2013 Nigeria Demographic and Health Survey, only 18% of children 6-23 months of age received at least 4 food groups in the previous 24 hours. 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?
- Egg demand creation campaign
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,453 participants
- Where
- 1 siteNigeria
- Study dates
- 9 Sep 2019to 8 Dec 2020
- 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
Who cannot join
- Vulnerable families (i.e., families headed by children, homeless families living on the street in the community, families with a severely mentally unstable head of household)
Trial locations and contacts
1 site in 1 country.
About this study
Improved infant and young child feeding, including dietary quality and diversity, is important for child health and development. In the 2013 Nigeria Demographic and Health Survey, only 18% of children 6-23 months of age received at least 4 food groups in the previous 24 hours. In Kaduna, one of the poorest states, dietary diversity is low and consumption of eggs is infrequent, with households reporting consuming eggs only one day per week. Eggs are a nutrient-dense food, which can contribute enormously to a child's dietary quality. This study evaluates whether a 14-month behavior change intervention about eggs can increase the procurement and consumption of eggs in children 6-59 months of age living in Nigeria. The intervention includes delivery of messages about the health benefits of eggs through Above-the-line methods and Below-the-line methods. The intervention is evaluated using a longitudinal quasi-experimental design in two states in Nigeria with pre- and post-test questionnaires designed to assess changes in acquisition and consumption of eggs.
Read the detailed description
The Global Alliance for Improved Nutrition (GAIN) seeks to improve dietary quality among children under-five years of age in Kaduna by increasing the demand for eggs through above-the-line and below-the-line behavior change interventions incorporating mass media, social media, and point-of-sale (POS) marketing. Above-the-line (ATL) interventions include television, radio, celebrity ambassadors and out-of-home (OOH) advertising (e.g., billboards). Below-the-line interventions (BTL) include interpersonal communication (IPC) activation, trade promotions, point-of-sale materials, food demonstrations and giveaways and door-to-door activation.
GAIN conducted a quasi-experimental longitudinal study of a demand creation campaign, using ATL and BTL interventions, among families of children 6-59 months of age to determine the impact on egg consumption among children and egg acquisition. Kaduna state was chosen as the intervention arm, and Kano state as the comparison arm. Within Kaduna state, the Kaduna North and Chikun local government areas (LGAs) were selected to receive ATL and BTL demand creation interventions. The comparison state, Kano, received no demand creation campaign.
The principal comparison for measuring the effect of demand creation interventions will be across states, comparing the combined effects of ATL and BTL interventions with the comparison areas which received no intervention.
Investigators also set out to determine the impact of this intervention on mediating outcomes in the hypothesized causal framework. Proximal mediators included caregivers' attitudes and beliefs toward eggs and willingness to pay for eggs.
- Conditions
- Egg Consumption
- Being tested
- Egg demand creation campaign
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Egg demand creation campaignBehavioural
Egg demand creation campaign including 14 months of above-the-line and below-the-line messaging.
| Study group | Role | What they receive |
|---|---|---|
| Egg demand creation campaign | Experimental | Egg demand creation campaign using Above-the-line and Below-the-line methods for 14 months. Above-the-line interventions include television, radio, celebrity ambassadors and out-of-home advertising (e.g., billboards). Below-the-line interventions include interpersonal communication activation, trade promotions, point-of-sale materials, food demonstrations and giveaways and door-to-door activation. Receives: Behavioral: Egg demand creation campaign |
| Comparison | No intervention | Comparison arm with no campaign |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the times eggs were consumed by children 6-59 months of age from baseline to endline
Change in the average number of times eggs were consumed in the past 7 days from baseline to endline in the two study arms
Measured: From baseline to 14 months
Change in the consumption of two or more eggs by children 6-59 months of age from baseline to endline
Change in the proportion of children consuming at least two eggs in the past 7 days from baseline to endline in the two study arms
Measured: From baseline to 14 months
Change in the availability of eggs by families of children 6-59 months of age from baseline to endline
Change in the proportion of households purchasing eggs and the change in the proportion of households acquiring eggs from baseline to endline in the two study arms
Measured: From baseline to 14 months
Secondary outcomes (3)
Change in the consumption of any eggs by children 6-59 months from baseline to endline in the two study arms
Change in the consumption of one or more eggs by children 6-59 months of age from baseline to endline
Measured: From baseline to 14 months
Change in caregivers' (of children 6-59 months) attitudes, beliefs, and knowledge of eggs from baseline to endline
Change in the mean factor score created from Likert scales of attitudes (attitudes scale, higher score reflects better attitudes towards eggs), perceived benefits (benefits scale, higher score reflects better perceived benefits 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 endline between the two study arms; change will be examined for a meta factor score combining all scales and each scale separately.
Measured: From baseline to 14 months
Change in caregivers' willingness to pay for eggs from baseline to endline
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 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start9 Sep 2019
- Primary completion8 Dec 2020
- Study completion8 Dec 2020
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.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- 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
- Longitudinal pre- post-evaluation of intervention and comparison group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,453 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
- NCT04937218
- Sponsor's protocol ID
- 101
- Status last verified
- Jun 2021
- First submitted
- 15 Jun 2021
- Last updated
- 30 Jun 2021
- 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 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Evaluation of GAIN Egg Campaign in Two Nigerian States
- ClinicalTrials.gov ID
- NCT04937218
- Acronym / sponsor ID
- 101
- Conditions
- Egg Consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,453 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- Global Alliance for Improved Nutrition
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 8 Dec 2020 (actual)
- Study completion
- 8 Dec 2020 (actual)
- First posted
- 23 Jun 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.
Improved infant and young child feeding, including dietary quality and diversity, is important for child health and development. In the 2013 Nigeria Demographic and Health Survey, only 18% of children 6-23 months of age received at least 4 food groups in the previous 24 hours. In Kaduna, one of the poorest states, dietary diversity is low and consumption of eggs is infrequent, with households reporting consuming eggs only one day per week. Eggs are a nutrient-dense food, which can contribute enormously to a child's dietary quality. This study evaluates whether a 14-month behavior change intervention about eggs can increase the procurement and consumption of eggs in children 6-59 months of age living in Nigeria. The intervention includes delivery of messages about the health benefits of eggs through Above-the-line methods and Below-the-line methods. The intervention is evaluated using a longitudinal quasi-experimental design in two states in Nigeria with pre- and post-test questionnaires designed to assess changes in acquisition and consumption of eggs.
Detailed description
The Global Alliance for Improved Nutrition (GAIN) seeks to improve dietary quality among children under-five years of age in Kaduna by increasing the demand for eggs through above-the-line and below-the-line behavior change interventions incorporating mass media, social media, and point-of-sale (POS) marketing. Above-the-line (ATL) interventions include television, radio, celebrity ambassadors and out-of-home (OOH) advertising (e.g., billboards). Below-the-line interventions (BTL) include interpersonal communication (IPC) activation, trade promotions, point-of-sale materials, food demonstrations and giveaways and door-to-door activation.
GAIN conducted a quasi-experimental longitudinal study of a demand creation campaign, using ATL and BTL interventions, among families of children 6-59 months of age to determine the impact on egg consumption among children and egg acquisition. Kaduna state was chosen as the intervention arm, and Kano state as the comparison arm. Within Kaduna state, the Kaduna North and Chikun local government areas (LGAs) were selected to receive ATL and BTL demand creation interventions. The comparison state, Kano, received no demand creation campaign.
The principal comparison for measuring the effect of demand creation interventions will be across states, comparing the combined effects of ATL and BTL interventions with the comparison areas which received no intervention.
Investigators also set out to determine the impact of this intervention on mediating outcomes in the hypothesized causal framework. Proximal mediators included caregivers' attitudes and beliefs toward eggs and 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
- Longitudinal pre- post-evaluation of intervention and comparison group
| Arm | Type | Receives |
|---|---|---|
| Egg demand creation campaign | Experimental | Behavioral: Egg demand creation campaignEgg demand creation campaign using Above-the-line and Below-the-line methods for 14 months. Above-the-line interventions include television, radio, celebrity ambassadors and out-of-home advertising (e.g., billboards). Below-the-line interventions include interpersonal communication activation, trade promotions, point-of-sale materials, food demonstrations and giveaways and door-to-door activation. |
| Comparison | No intervention | –Comparison arm with no campaign |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Living in the project areas
Key exclusion criteria (1 listed)
- Vulnerable families (i.e., families headed by children, homeless families living on the street in the community, families with a severely mentally unstable head of household)
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 demand creation campaignEgg demand creation campaign including 14 months of above-the-line and below-the-line messaging. | Behavioural | Egg demand creation campaign |
Primary outcome
Change in the times eggs were consumed by children 6-59 months of age from baseline to endline
Time frame: From baseline to 14 months
Change in the average number of times eggs were consumed in the past 7 days from baseline to endline in the two study arms
Change in the consumption of two or more eggs by children 6-59 months of age from baseline to endline
Time frame: From baseline to 14 months
Change in the proportion of children consuming at least two eggs in the past 7 days from baseline to endline in the two study arms
Change in the availability of eggs by families of children 6-59 months of age from baseline to endline
Time frame: From baseline to 14 months
Change in the proportion of households purchasing eggs and the change in the proportion of households acquiring eggs from baseline to endline in the two study arms
3 secondary outcomes
Change in the consumption of any eggs by children 6-59 months from baseline to endline in the two study arms
Time frame: From baseline to 14 months
Change in caregivers' (of children 6-59 months) attitudes, beliefs, and knowledge of eggs from baseline to endline
Time frame: From baseline to 14 months
Change in caregivers' willingness to pay for eggs from baseline to endline
Time frame: From baseline to 14 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 30 Jun 2021.
- 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 Egg demand creation campaign in people with Egg Consumption, run by University of South Carolina 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 1 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 30 Jun 2021. 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 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 times eggs were consumed by children 6-59 months of age from baseline to endline (time frame: From baseline to 14 months). The study lists 3 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 30 Jun 2021.