Impact of Food-to-Food Fortified Cereal Products on Diet Quality in Eldoret, Kenya

Iron-deficiency Clinical Trial

— KenyaMPS  

Official title:

Kenya Market Study for Food-to-Food Fortified (F2F) Instant Porridge Flours

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05882682
• Other study ID #: IRB-2022-695
• Status: Completed
• Start date: October 20, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: May 2023
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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 will be 1) to assess the nutritional adequacy of Kenyan 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 will simulate a market study, the investigators conducted a product launch, determined market potential based on sales, evaluated marketing strategy to increase market share, and modeled the nutritional contribution of FtFF/traditionally fortified product for iron, zinc, and vitamin A. The investigators expect to provide a throughout evaluation of a business-driven strategy (for profit, social enterprise) as a sustainable tool to decrease micronutrient deficiencies.

Description:

Basic design:

Participants will be approached/recruited by research assistants on the ground at designated local markets. Potential participants will be consented if they agree to join the study at the time of recruitment. While attendance is not required by participants, product demonstrations will be conducted at the study sites, similar to a grocery store demonstration, to show how the instant flour is reconstituted. At the same time, consumers who are attending the demonstrations may be asked if they would participate in the study. Research assistants will read the consent form to the participants and ensure they understand it. Purdue investigator(s) (one or more - Torres-Aguilar, Rendall, Hamaker) will be present in Eldoret at all study phases involving consenting and data collection.

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 Weeks 3-5: Product sold at below market cost of other cereal flour products (as part of active promotion) Weeks 6-10: At one half of the locations, product sold at parity to other cereal products (with advertising but no additional promotion, i.e. discounts).

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:

1. Total volume/units of FtFF fortified product sold

2. Total volume/units cereal products sold

3. Total value of FtFF fortified product sold

4. TotaI value of cereal product sold

5. Product comments from consumers (include any returns or complaints)

6. Number of repeat purchasers

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1800
• Est. completion date: December 30, 2022
• Est. primary completion date: December 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Months and older

Eligibility

Inclusion Criteria:

• Adults (>18 years of age), with child(ren) 5 years of age living in the household.

Exclusion Criteria:

• No children under 5 y of age living in the household.

• Not a caregiver for the children in the household.

Related Conditions & MeSH terms

• Iron-deficiency
• Night Blindness
• Vitamin A Deficiency

Locations

Country	Name	City	State
Kenya	University of Eldoret	Eldoret	Uasin Gishu

Sponsors (1)

Lead Sponsor	Collaborator
Purdue University

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of staple intake in urban Kenyan 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. We will ask #times/week each staple was consumed as well as the average portion size consumed each time (g).	10 weeks
Primary	Assessment of the nutritional adequacy of urban Kenyan 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 Kenyan maternal and child health expert. This will be measured in #times/week each food group was consumed.	10 weeks