Back to resultsA New Measure of Egg Consumption and the Effect of Social Marketing Eggs
Primary Purpose
Nutritional Stunting
Status
Completed
Phase
Not Applicable
Locations
Malawi
Study Type
Interventional
Intervention
Social Marketing Campaign
Sponsored by
About this trial
This is an interventional other trial for Nutritional Stunting
Eligibility Criteria
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
Sites / Locations
- Project Peanut Butter
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Social Marketing Campaign
No Social Marketing Campaign
Arm Description
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 egg hugs will not receive social marketing campaign.
Outcomes
Primary Outcome Measures
Amount of egg consumed daily
As determined by urinary metabolite concentrations. The specific metabolites will be identified in the course of the study.
Secondary Outcome Measures
Full Information
NCT ID
NCT04461106
First Posted
June 22, 2020
Last Updated
February 23, 2023
Sponsor
Washington University School of Medicine
Collaborators
Project Peanut Butter, Malawi, Kamuzu University of Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04461106
Brief Title
A New Measure of Egg Consumption and the Effect of Social Marketing Eggs
Official Title
A Two-Phase Study to Investigate Novel Biomarkers of Egg Consumption and Social Marketing Effectiveness of Egg Hubs for Malawian Infants
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 26, 2021 (Actual)
Primary Completion Date
September 10, 2021 (Actual)
Study Completion Date
September 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Project Peanut Butter, Malawi, Kamuzu University of Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutritional Stunting
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
815 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Social Marketing Campaign
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No Social Marketing Campaign
Arm Type
No Intervention
Arm Description
Other egg hugs will not receive social marketing campaign.
Intervention Type
Other
Intervention Name(s)
Social Marketing Campaign
Intervention Description
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
Primary Outcome Measure Information:
Title
Amount of egg consumed daily
Description
As determined by urinary metabolite concentrations. The specific metabolites will be identified in the course of the study.
Time Frame
12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Manary, MD
Organizational Affiliation
Washington University School of Medicine in St. Louis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Project Peanut Butter
City
Blantyre
Country
Malawi
12. IPD Sharing Statement
Citations:
PubMed Identifier
28089709
Citation
Garcia-Perez I, Posma JM, Gibson R, Chambers ES, Hansen TH, Vestergaard H, Hansen T, Beckmann M, Pedersen O, Elliott P, Stamler J, Nicholson JK, Draper J, Mathers JC, Holmes E, Frost G. Objective assessment of dietary patterns by use of metabolic phenotyping: a randomised, controlled, crossover trial. Lancet Diabetes Endocrinol. 2017 Mar;5(3):184-195. doi: 10.1016/S2213-8587(16)30419-3. Epub 2017 Jan 13.
Results Reference
background
PubMed Identifier
30518059
Citation
S C Sri Harsha P, Abdul Wahab R, Cuparencu C, Dragsted LO, Brennan L. A Metabolomics Approach to the Identification of Urinary Biomarkers of Pea Intake. Nutrients. 2018 Dec 4;10(12):1911. doi: 10.3390/nu10121911.
Results Reference
background
PubMed Identifier
27609557
Citation
Koppmair S, Kassie M, Qaim M. Farm production, market access and dietary diversity in Malawi. Public Health Nutr. 2017 Feb;20(2):325-335. doi: 10.1017/S1368980016002135. Epub 2016 Sep 9.
Results Reference
background
PubMed Identifier
30779870
Citation
Eaton JC, Rothpletz-Puglia P, Dreker MR, Iannotti L, Lutter C, Kaganda J, Rayco-Solon P. Effectiveness of provision of animal-source foods for supporting optimal growth and development in children 6 to 59 months of age. Cochrane Database Syst Rev. 2019 Feb 19;2(2):CD012818. doi: 10.1002/14651858.CD012818.pub2.
Results Reference
background
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A New Measure of Egg Consumption and the Effect of Social Marketing Eggs
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