Vitamin A DeficiencyKenyaMPSNCT05882682
Impact of Food-to-Food Fortified Cereal Products on Diet Quality in Eldoret, Kenya
An observational study of Vitamin A Deficiency and Iron-deficiency, run by Purdue University at 1 site in Kenya.
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. Read more about this study
- Who is it for?
- Ages 18 months and olderHealthy volunteers can take part
- Conditions the study is for
- Vitamin A Deficiency, Iron-deficiency
- How many people
- 1,800 participants
- Where
- 1 siteKenya
- Study dates
- 20 Oct 2022to 30 Dec 2022
- How long will I take part?
- 10 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Adults (>18 years of age), with child(ren) 5 years of age living in the household.
Who cannot join
- No children under 5 y of age living in the household.
- Not a caregiver for the children in the household.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Kenya Market Study for Food-to-Food Fortified (F2F) Instant Porridge Flours
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.
Read the detailed 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:
- Total volume/units of FtFF fortified product sold
- Total volume/units cereal products sold
- Total value of FtFF fortified product sold
- TotaI value of cereal product sold
- Product comments from consumers (include any returns or complaints)
- 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.
- Conditions
- Vitamin A Deficiency, Iron-deficiency
- Medical subject headings
- Vitamin A Deficiency, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Consumers of cereal products | Caregivers with children under 5 years of age who are consumer of cereal products in the Eldoret area. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start20 Oct 2022
- Primary completion12 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin A DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,800 participants (actual)
- Target duration
- 10 Weeks
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce R. Hamaker, Purdue University
- Investigators
- Bruce R Hamaker, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882682
- Sponsor's protocol ID
- IRB-2022-695
- Acronym
- KenyaMPS
- Status last verified
- May 2023
- First submitted
- 14 Mar 2023
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No PI was collected. There is not a plan to share participant information.
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kenya Market Study for Food-to-Food Fortified (F2F) Instant Porridge Flours
- ClinicalTrials.gov ID
- NCT05882682
- Acronym / sponsor ID
- KenyaMPS / IRB-2022-695
- Conditions
- Vitamin A Deficiency, Iron-deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,800 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- Total volume/units of FtFF fortified product sold
- Total volume/units cereal products sold
- Total value of FtFF fortified product sold
- TotaI value of cereal product sold
- Product comments from consumers (include any returns or complaints)
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 10 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Consumers of cereal products | – | –Caregivers with children under 5 years of age who are consumer of cereal products in the Eldoret area. |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Adults (>18 years of age), with child(ren) 5 years of age living in the household.
Key exclusion criteria (2 listed)
- No children under 5 y of age living in the household.
- Not a caregiver for the children in the household.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of staple intake in urban Kenyan households and children
Time frame: 10 weeks
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).
Assessment of the nutritional adequacy of urban Kenyan households and children
Time frame: 10 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Individual participant dataSharing planned: No. No PI was collected. There is not a plan to share participant information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce R Hamaker principal investigator
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin A Deficiency and Iron-deficiency, run by Purdue University at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of staple intake in urban Kenyan households and children (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.