Clinical trial NCT05893901: Impact of Food-to-Food Fortified Cereal Products on Diet Quality in Rural Niger Villages
Official title: Impact of Food-to-Food Fortified Cereal Products on Diet Quality in Rural Niger Villages
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin A Deficiency
Iron-deficiency
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 3600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

Detailed description: Study Summary: Over the years our group has developed a Hub-and-Spoke incubator system to facilitate technology transfer and enable production, marketing, and sales of nutritionally improved cereal products in rural Niger. These efforts have led to the introduction of products developed using food-to-food fortification technology (FtFF). Examples of this include addition of moringa, carrot, cowpea, baobab powders to flours made with indigenous whole grains such as millet or sorghum. This technology leverages local nutrient dense plants to fortify cereal product traditionally consumed as porridges. These products are closely aligned to Corn-Soy Blends that are provided by international aid groups and dispensed/distributed through health centers at the village level. While these products provide a more complete nutritional profile for growing children and their families, their acceptability by children not always good and sustainability is poor as they are donor supported. Efforts to enhance the local community's food security and enhance nutritional quality of diets through local production and sales of FtFF products is key to developing sustainable improvements in local diets and nutrient availability. The investigators believe that the presence of Hub and Spoke incubator is critical to the success of these efforts, but data is needed to confirm their impact on the local food environment.

Study procedures:

Participants will be approached/recruited by research assistants (enumerators) in local markets and at sales locations. 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.

During the consumer interview, the investigators will be collecting the following information:

Consumer socioeconomics (for all) - this includes sex and age of each family member (no names or birth dates), and education level of the respondent Modified Food Frequency Questionnaire (for all) Diet Diversity Questionnaire - focus on pearl millet consumption (for all) Product specific questionnaire (for purchasers only)

* Product use: time of day, people in the household
* Product attributes they found most attractive
* 5-point-like scale: appearance, aroma, texture, taste.
* Overall convenience of flour product
* If small children were fed product, did they like it?
* Did other children like it?
* What did it replace?

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of staple intake in urban Nigerien households and children
timeFrame: 3 months
measure: Assessment of the nutritional adequacy of Nigerien children
timeFrame: 3 years
measure: Nutritional impact of a fortified cereal-based product for the improvement of micronutrient deficiencies among children aged 24-60 months.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Niamey
country: Niger
facility: INRAN
Study officials:
affiliation: Purdue University
name: Bruce R Hamaker, PhD
role: PRINCIPAL_INVESTIGATOR
References: