A New Measure of Egg Consumption and the Effect of Social Marketing Eggs

Sponsor
Washington University School of Medicine (Other)
Overall Status
Recruiting
CT.gov ID
NCT04461106
Collaborator
Project Peanut Butter, Malawi (Other), University of Malawi College of Medicine (Other)
1,800
1
2
19.1
94.3

Study Details

Study Description

Brief Summary

About 1600 children 6 to 24 months old will be enrolled from 8 egg hubs. 4 hubs will be receive social marketing campaign to raise awareness about the benefits of eggs while the other 4 will not receive social marketing campaign. Children will provide a urine sample for analysis of metabolites to correlate with egg consumption.

Condition or Disease Intervention/Treatment Phase
  • Other: Social Marketing Campaign
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1800 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Other
Official Title:
A Two-Phase Study to Investigate Novel Biomarkers of Egg Consumption and Social Marketing Effectiveness of Egg Hubs for Malawian Infants
Actual Study Start Date :
Feb 26, 2021
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Social Marketing Campaign

Select egg hubs will receive social marketing campaign which aims to raise awareness about the benefits of eggs - 'why eggs': increasing the value of eggs from a consumer perspective and encourage consumption of eggs by children (<5yrs) and pregnant/lactating women.

Other: Social Marketing Campaign
aims to raise awareness about the benefits of eggs - 'why eggs': increasing the value of eggs from a consumer perspective and encourage consumption of eggs by children (<5yrs) and pregnant/lactating women

No Intervention: No Social Marketing Campaign

Other egg hugs will not receive social marketing campaign.

Outcome Measures

Primary Outcome Measures

  1. Amount of egg consumed daily [12 Months]

    As determined by urinary metabolite concentrations. The specific metabolites will be identified in the course of the study.

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Months to 24 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Health children between 6 and 24 months of age
Exclusion Criteria:
  • acute malnutrition

  • congenital abnormalities

  • chronic debilitation disease such as heart disease, cerebral palsy, or HIV infection

Contacts and Locations

Locations

Site City State Country Postal Code
1 Project Peanut Butter Blantyre Malawi

Sponsors and Collaborators

  • Washington University School of Medicine
  • Project Peanut Butter, Malawi
  • University of Malawi College of Medicine

Investigators

  • Principal Investigator: Mark Manary, MD, Washington University School of Medicine in St. Louis

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT04461106
Other Study ID Numbers:
  • 202007077
First Posted:
Jul 8, 2020
Last Update Posted:
Apr 13, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 13, 2021