A two-phase study to investigate novel biomarkers of egg consumption and social marketing effectiveness of egg hubs Malawian infants

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Date
2020-06-22
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Kamuzu University of Health Sciences
Abstract
Type of Study: :A controlled feeding study with infants and randomized controlled effectiveness trial to evaluate the impact of social marketing on egg consumption among vulnerable Malawian infants. Problem to be studied: A reliable and convenient way to measure the quantity of egg consumed by an individual. Current dietary assessment methods rely on self-report food intake such as food frequency questionnaires, 24-hr dietary recall, or diet diaries, and the prevalence of misreporting with these tools is estimated at 30-88%. Because there is no reliable way to detect egg consumption, the impact of a social marketing campaign on egg consumption among children in central Malawi in the vicinity of small-scale egg producers is not known. Objective: Identify a novel set of dietary biomarkers that will measure egg consumption, that would be free from participant recall bias, and serve to quantify intake. Utilize novel egg consumption biomarkers to measure egg consumption among infants in communities with social marketing campaigns have been implemented. Methodology:: Phase 1: A total of 25 subjects, children (9-24 months) will consume 2 distinct daily intake dosages of eggs with the daily intake increased every 5 days. Urine samples will be collected 3 times during each 5-day period and blood spots will be collected during a washout period and at the end of the each 5-day period. Urine samples will undergo metabolite detection via ultraperformance liquid chromatography tandem mass spectrometry in positive and negative ion mode. Peaks will be quantified using area-under-the-curve summation and each metabolite will be quantified in terms of its median-scaled relative abundance for the metabolite across the entire data set. A repeated measures 2-way ANOVA will be used to compare egg metabolite abundances over time in an individual baseline level. The result of phase 1 will be that the amount of egg consumed will be able to be measured accurately with a urine test. Phase 2: Among eight different “egg hubs”, a cluster of 10 egg farmers, 4 egg hubs will be randomized to receive social marketing and 4 will not receive social marketing. At the onset of the study before social marketing is implemented, and once a month for 8 months, there will be 1 monitoring day per month in the vicinity of each of the 8 different egg hubs. All will be welcomed, especially mothers of children 6-24 months, during this monitoring day, the research staff will provide community education about good complementary feeding practices. Among the children between 6-24 months, up to 25 will recruited to provide some basic demographic and health information, anthropometric measurements, and to give a urine specimen. Urine samples will undergo detection of the novel biomarker from phase 1 to determine egg consumption. Consumption between intervention and control sites will be compared to detect differences in egg consumption at each time point during the intervention. Expected finding: Egg metabolites that serve as exposure markers, and with varied abundance over time from urine. Novel egg biomarkers will provide a non-bias assessment of the effectiveness of social marketing campaign on egg consumption among vulnerable Malawian children. Dissemination of the results: A report of all results will be submitted to the supporting institutions (The College of Medicine – University of Malawi, Washington University School of Medicine) as well as to COMREC and the participating patients that wish to receive the results. The results will further be submitted to a peer-reviewed journal for publication
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