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

NCT05882682 | Completed

• 1 other identifier: IRB-2022-695
• Study Type: observational
• Target: 1,800
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vitamin A Deficiency; Iron-deficiency

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Consumers of cereal products

Caregivers with children under 5 years of age who are consumer of cereal products in the Eldoret area.

Eligibility Criteria

• Age: 18 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

• No children under 5 y of age living in the household.
• Not a caregiver for the children in the household.

Sponsors & Collaborators

• Purdue University: lead

Study Sites (1)

University of Eldoret

Eldoret, Uasin Gishu County, Kenya

Location

MeSH Terms

Conditions

Vitamin A Deficiency; Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases

Study Officials

• Bruce R Hamaker

  Purdue University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 10 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator / Distinguished professor

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: May 31, 2023
• Study Start: October 20, 2022
• Primary Completion: December 12, 2022
• Study Completion: December 30, 2022
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)