Complementary Feeding Project in Ethiopia

August 1, 2022 updated by: Edward Frongillo, Jr., University of South Carolina
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1132

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ethiopia
      • Addis Ababa, Ethiopia
        • Deep Dive Research and Consulting PLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 months to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Living in the project areas
  • Caregiver 18 years old or above

Exclusion Criteria:

  • households without children between the ages of 6-59 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Complementary feeding program
Promotion of eggs.
Behavioral: Complementary feeding intervention

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.
No Intervention: Comparison
Comparison arm with no program

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
From baseline to 22 months
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
From baseline to 22 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in household egg production from baseline to end-line
Time Frame: From baseline to 22 months
Change in the proportion of households producing eggs from baseline to end-line in the two study arms
From baseline to 22 months
Change in egg purchasing from baseline to end-line
Time Frame: From baseline to 22 months
Change in the proportion of households that purchased egg in the last month from baseline to end-line in the two study arms
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 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.
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
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.
From baseline to 22 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of South Carolina

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Global Alliance for Improved Nutrition

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Edward A Frongillo, PhD, University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 30, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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.

IPD Sharing Supporting Information Type

  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Egg Consumption

Clinical Trials on Complementary feeding intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings