NCT04461106

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
815

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 8, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

February 26, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2022

Completed
Last Updated

February 27, 2023

Status Verified

February 1, 2023

Enrollment Period

7 months

First QC Date

June 22, 2020

Last Update Submit

February 23, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Amount of egg consumed daily

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

    12 Months

Study Arms (2)

Social Marketing Campaign

ACTIVE COMPARATOR

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

No Social Marketing Campaign

NO INTERVENTION

Other egg hugs will not receive social marketing campaign.

Interventions

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

Social Marketing Campaign

Eligibility Criteria

Age6 Months - 24 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Health children between 6 and 24 months of age

You may not qualify if:

  • acute malnutrition
  • congenital abnormalities
  • chronic debilitation disease such as heart disease, cerebral palsy, or HIV infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Project Peanut Butter

Blantyre, Malawi

Location

Related Publications (4)

  • 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.

    PMID: 28089709BACKGROUND
  • 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.

    PMID: 30518059BACKGROUND
  • 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.

    PMID: 27609557BACKGROUND
  • 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.

    PMID: 30779870BACKGROUND

Study Officials

  • Mark Manary, MD

    Washington University School of Medicine in St. Louis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2020

First Posted

July 8, 2020

Study Start

February 26, 2021

Primary Completion

September 10, 2021

Study Completion

September 10, 2022

Last Updated

February 27, 2023

Record last verified: 2023-02

Locations