An observational study in Iron-deficiency and Vitamin A Deficiency, sponsored by Purdue University. Completed at 1 site in Senegal. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-01.
Sponsored by Purdue University · Observational
The overall hypotheses is that a product designed with optimized nutritional characteristics, based on consumer preferences and leveraging local nutrient dense ingredients, can successfully deliver nutrition through sustainable market-driven approaches.
The objectives of this study were 1) to assess the nutritional adequacy of urban Senegalese households with children and 2) to determine the market potential of a locally sourced and manufactured, blended fortified, cereal-based product for the improvement of micronutrient deficiencies among children aged 24-60 months. This study simulates a market study, the investigators will conduct a product launch, determine market potential based on sales, evaluate marketing strategy to increase market share, and model the nutritional contribution of FtFF/traditionally fortified product for iron, zinc, and vitamin A. The investigators expect to provide a thorough evaluation of a business-driven strategy (for profit, social enterprise) as a sustainable tool to decrease micronutrient deficiencies.
Basic design:
Participants will be approached/recruited by research assistants on the ground at designated local markets. Potential participants will be approached and consented if they agree to join the study at the time of recruitment. Research assistants will read the consent form to the participants and ensure they understand it.
Products will be produced, distributed on a weekly basis to sites. The investigators plan on introducing the "new" product to consumers at random at in-store displays at individual locations for 2 weeks, and then continue to promote (advertise) and sell the placed product for a period of 8 weeks. The following schedules are proposed:
Weeks 1-2: Product demonstrations and sampling for consumers (with promotion and free samples) Weeks 3-5: Product sold at below market cost of other millet or cereal flour products (as part of active promotion) Weeks 6-10: At one half of the locations, product sold at parity to millet or other cereal products (with advertising but no additional promotion, i.e. discount) Weeks 6-10: At one half of the locations product sold at parity +20% price to millet or other cereal products (with advertising but no additional promotion)
Data to be collected both from store managers and individual consumers. Enumerators will be trained and placed at each sales' location in the morning and evening to coincide with peak shopping times. They will be tasked with collecting a random sample of consumers who are purchasing cereals (1,200 total over 10 weeks). In this sample, both purchasers and non-purchasers of the FtFF fortified products will be identified and consented. Phone numbers will be collected and a follow up appointment/interview scheduled with half of them (600). Enumerators will also coordinate the collection of data from point of sale managers:
Follow up interviews with consumers will be conducted at a private location close to the centralized market sites or points of original purchase within 2 weeks. This is to enable follow up without inconveniencing participant.
Product Production and Distribution Plan: Through a local commercial food processor Product form: 500 g size for sale. 50 g size for promotion.
600 studies on the registry are indexed under Anemia, Iron-Deficiency; 95 are open to participants now.
This study's enrollment of 1,800 is above the median of 200 across 118 observational studies indexed under Anemia, Iron-Deficiency.
Browse Anemia, Iron-Deficiency studies →Purdue University is the lead sponsor of 175 studies on the registry; 21 are open to participants now.
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This study will collect data about dietary habits for children and the household they lived. Adult caregivers will be approached and provided the relevant information.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
This study will evaluate the market potential of a food-to-food fortified (FtFF) flour.
Assessment of staple intake in urban Senegalese households and children
A quantitative, modified food frequency questionnaire (FFQ) will be used to assess consumption of various starch rich staples (rice, corn, sorghum, millet, potatoes, cassava) and starch-rich processed foods (bread) for the whole household and children. The caregiver will provide information about the child's amount and frequency of consumption. This will be measured in g/day\*child. The investigators will ask #times/week each staple was consumed as well as the average portion size consumed each time (g).
Time frame: 10 weeks
Assessment of the nutritional adequacy of urban Senegalese households and children
Nutritional status of children in the household will be assessed using the Food Consumption Score Nutritional Quality Analysis (FCS-N) which was based on country-specific food groups. Food groups are orange fruits, orange vegetables, other fruits, eggs, dairy, organ meats, meat, fish, grains and legumes. Example of food items in the FCS-N assessment will be corroborated by a Senegalese maternal and child health expert. This will be measured in #times/week each food group was consumed.
Time frame: 10 weeks
Nutritional impact of a fortified cereal-based product for the improvement of micronutrient deficiencies among children aged 24-60 months.
Fortified flour consumption will be assessed by fortified flours intake (g/child\*day). Micronutrient contribution will calculated by multiplying the amount of flour consumed/child \* (mg zinc/g flour), (mg iron/g flour) and (ug RAE vitamin A/g flour).
Time frame: 10 weeks
Plan to share: No — No PI was collected. There is not a plan to share participant information.
No publications or documents are linked to this record.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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