Impact of Food-to-Food Fortified Cereal Products on Diet Quality in Rural Niger Villages

NCT05893901 | Completed

• 1 other identifier: IRB-2022-571
• Study Type: observational
• Target: 3,600
• Locations: 1 country
• Sites: 1

Brief Summary

The primary hypothesis is that introduction of food-to-food fortified products through a rural Hub-and-Spoke incubator system contributes to an improved food environment and availability of micronutrients to these communities. A secondary hypothesis is that the influence of the rural Spokes can serve to enhance rural food environments through creation of secondary rural spokes that disseminate improved food-to-food fortified products. The overall hypothesis 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.

Conditions

Vitamin A Deficiency; Iron-deficiency

Outcome Measures

Primary Outcomes (3)

• Assessment of staple intake in urban Nigerien households and children

  A quantitative, modified food frequency questionnaire (FFQ) will be used to assess consumption of starch rich staples (rice, wheat, corn sorghum, millet, fonio, potatoes, cassava, yams) for the whole household and children. This will be measured in g/day\*child. The investigators will ask #times/week eachstaple was consumed as well as the average portion size consumed each time (g).The caregiver will provide information about the child's frequency of consumption over the past week for each food group.

  3 months

• Assessment of the nutritional adequacy of Nigerien children

  Nutritional status of children in the household will be assessed using theFood Consumption Score Nutritional Quality Analysis (FCS-N) which wasbased 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 Nigerien maternal and child health expert. This will be measured in #times/week each food group was consumed.

  3 years

• 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).

  3 months

Study Arms (1)

Consumers of cereal products

Caregivers with children under 5 years of age who are consumer of cereal products in the Maradi, Falwell and Tera areas in Niger.

Eligibility Criteria

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

Study Population

This study collected data about dietary habits for children and the household they lived. Adult caregivers were 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)

INRAN

Niamey, Niger

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, PhD

  Purdue University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator / Distinguished professor

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 8, 2023
• Study Start: March 13, 2023
• Primary Completion: May 30, 2023
• Study Completion: June 30, 2023
• Last Updated: July 11, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

NI (1)