MalnutritionCAT01NCT01258647
Acceptability of a Cereal for Complementary Feeding of Infants and Young Children Made From Caterpillars
A study testing caterpillar cereal in people with Malnutrition and Stunting of Growth, run by University of North Carolina, Chapel Hill at 1 site in Republic of the Congo.
Trial summary
Two in every three infants in rural areas of the Democratic Republic of Congo (DRC) suffer from stunting of linear growth by 12 months of age. Stunting presumably results from breast milk supplementation after 6 months of age with complementary foods (CF) that provide inadequate protein and micronutrients. Read more about this study
- Who is it for?
- Ages 8 to 10 monthsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition, Stunting of Growth
- What is being tested?
- caterpillar cereal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteRepublic of the Congo
- Study dates
- Oct 2010to Oct 2010
- Phase
- Interventional
- 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 8 to 10 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Any mother-infant dyad living within each a study community in the Equateur Province. Infants must be 8-10 months of age at the time of recruitment.
Who cannot join
- Infants with minor inter-current illness that may interfere with oral intake
- Infants of multiple gestation births
- Infants with congenital anomalies
- Infants likely to receive free or subsidized complementary foods (or infant formula)
Trial locations and contacts
1 site in 1 country.
Republic of the Congo1 site
Kinshasa School of Public Health
Kinshasa, B.P. 11850
About this study
Official title: Caterpillar Cereal: Maternal and Infant Acceptability
Two in every three infants in rural areas of the Democratic Republic of Congo (DRC) suffer from stunting of linear growth by 12 months of age. Stunting presumably results from breast milk supplementation after 6 months of age with complementary foods (CF) that provide inadequate protein and micronutrients. Although supplementation with selected micronutrients may avoid certain deficiency states, CF with animal source foods may be necessary to avoid stunting. Meat is not readily available in many Central African countries. However caterpillars, which are locally available and abundant, are a common staple in adult diets and may be a suitable substitute for animal source proteins in CF. The investigators developed a cereal made from dried caterpillars that has a nutrient content that appears to be ideal for CF. Maternal and infant acceptability will be evaluated in 20 mothers and their 8 month old infants. The investigators hypothesize that this cereal will be accepted by both mothers and infants: acceptability will be based on a priori definitions.
Read the detailed description
In preparation for a controlled study of the efficacy of daily intake of caterpillar cereal versus the usual diet from 6 to 18 months of age in reducing the rate of stunting of linear growth, and the improvement in other health outcomes, we will conduct an acceptability trial. In this trial, we will test the mothers' acceptance of the caterpillar cereal and their willingness to feed their young children this product. We will also test the infants' acceptance and their capacity to consume quantities required in the controlled trial necessary to deliver the desired quantities of micronutrients.
Study Design
A cohort of 20 mother-infant dyads will be recruited. The site of recruitment will be the area Health Center. Infants will be between 8 and 10 months of age and will have no major health problems. Infants with minor, inter-current illnesses at the time of recruitment that might interfere with oral intake will be excluded. After informed consent, maternal and infant acceptability will be tested using the methods described below.
Maternal Acceptability
Mothers will be provided with a 30 g portion of caterpillar cereal and will be instructed in the proper technique for preparation. After preparation, mothers will be asked to evaluate five features of the cereal. They will also be asked to provide their overall impression of the cereal. In each category, the evaluation will be assigned a numerical score using a five-part Likert scale, from "like very much" to "dislike very much".
The evaluation will be conducted by the Community Coordinator (CC) who will provide instruction about cereal preparation and administer the evaluative tool. Each evaluation will be conducted confidentially. Mothers will not be aware of the response of other mothers. At the conclusion of a one-week period of feeding (see below), a questionnaire will be administered to assess mothers' attitudes about their willingness to participate in a one-year study of cereal feeding.
We do not intend to evaluate their attitudes about food preparation. The recommended preparation technique of the caterpillar cereal is very similar to preparation of enriched soy cereal in our ongoing complementary feeding study. This involves boiling water and cooking the cereal for approximately three minutes. Although this preparation technique is burdensome, it has not compromised compliance in the ongoing study. Therefore, we would expect a similar response from mothers in the proposed study.
Infant Acceptability
Following the evaluation of maternal acceptability, each mother will be provided with a one-week supply of caterpillar cereal (7 individual packets containing 30 g each). She will be instructed to begin daily feedings on the following day, and to continue until the cereal packets have all been used. The first feeding will occur during a home visit by the CC, who will repeat the preparation instructions, and will observe the first feeding. The CC will return to the home on alternate days throughout the week to reinforce instructions regarding preparation, and to make observations about infant feeding habits. Although frequent visits may influence the likelihood of maternal compliance and hence may mislead investigators about maternal acceptability, it will not effect infant acceptability.
Mothers will be instructed not to feed the cereal to other household members, and will be asked to return uneaten cereal to the original packet for collection by the CC at the end of the week.
On the 8th day, the day following the completion of use of the cereal, the CC will return to the home for the purpose of data collection. The CC will administer a 24-hour dietary recall, and collect all cereal packets. In addition, mothers will be asked questions about the infant's health status.
- Conditions
- Malnutrition, Stunting of Growth
- Being tested
- caterpillar cereal
- Keywords
- infant nutrition, complementary feeding, malnutrition, stunting of growth
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caterpillar cerealDietary supplement
A 30 gram portion of a cereal containing one part dried, ground caterpillar, one part corn flour and small quantities of sugar and palm oil will be evaluated by the mothers and then fed daily for seven days to infants.
| Study group | Role | What they receive |
|---|---|---|
| Feeding group | Experimental | The feeding group will include 20 mother/infant dyads. The infants will be between 8 and 10 months of age. Receives: Dietary Supplement: caterpillar cereal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal acceptability
Maternal acceptability will be defined as a median score for each of 5 features (smell, taste, texture, color, consistency, overall impression) of 3 or greater on a 5 point Likert scale.
Measured: Maternal acceptability will be measured on the first day of the trial.
Infant acceptability
Each mother will be provided with a one-week supply of caterpillar cereal and will be instructed to begin daily feedings for a period of one week. Infant acceptability will be defined as the consumption of greater than 75% of the total cereal allotment by all infants during the last four days of feeding.
Measured: Infant acceptability will be measured during the one week study period.
Secondary outcomes (1)
Infant tolerance
During the visits by the Community Coordinator, mothers will be asked question about the infant's health status and specifically about any signs or symptoms attributable to feeding.
Tolerance will be defined as the absence of signs or symptoms attributable to cereal consumption (diarrhea or emesis unless other family members have developed these symptoms during the week of feeding).
Measured: This outcome will be measured throughout the one week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Kinshasa School of Public Health, University of California, Davis, Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Carl Bose, University of North Carolina, Chapel Hill
- Investigators
- Carl L Bose, MD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01258647
- Sponsor's protocol ID
- 10-0509
- Acronym
- CAT01
- Status last verified
- Aug 2011
- First submitted
- 9 Dec 2010
- Last updated
- 30 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caterpillar Cereal: Maternal and Infant Acceptability
- ClinicalTrials.gov ID
- NCT01258647
- Acronym / sponsor ID
- CAT01 / 10-0509
- Conditions
- Malnutrition, Stunting of Growth
- Keywords
- infant nutrition, complementary feeding, malnutrition, stunting of growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Kinshasa School of Public Health, University of California, Davis, Bill and Melinda Gates Foundation
- Study start
- Oct 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 13 Dec 2010 (estimated)
- 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.
Two in every three infants in rural areas of the Democratic Republic of Congo (DRC) suffer from stunting of linear growth by 12 months of age. Stunting presumably results from breast milk supplementation after 6 months of age with complementary foods (CF) that provide inadequate protein and micronutrients. Although supplementation with selected micronutrients may avoid certain deficiency states, CF with animal source foods may be necessary to avoid stunting. Meat is not readily available in many Central African countries. However caterpillars, which are locally available and abundant, are a common staple in adult diets and may be a suitable substitute for animal source proteins in CF. The investigators developed a cereal made from dried caterpillars that has a nutrient content that appears to be ideal for CF. Maternal and infant acceptability will be evaluated in 20 mothers and their 8 month old infants. The investigators hypothesize that this cereal will be accepted by both mothers and infants: acceptability will be based on a priori definitions.
Detailed description
In preparation for a controlled study of the efficacy of daily intake of caterpillar cereal versus the usual diet from 6 to 18 months of age in reducing the rate of stunting of linear growth, and the improvement in other health outcomes, we will conduct an acceptability trial. In this trial, we will test the mothers' acceptance of the caterpillar cereal and their willingness to feed their young children this product. We will also test the infants' acceptance and their capacity to consume quantities required in the controlled trial necessary to deliver the desired quantities of micronutrients.
Study Design
A cohort of 20 mother-infant dyads will be recruited. The site of recruitment will be the area Health Center. Infants will be between 8 and 10 months of age and will have no major health problems. Infants with minor, inter-current illnesses at the time of recruitment that might interfere with oral intake will be excluded. After informed consent, maternal and infant acceptability will be tested using the methods described below.
Maternal Acceptability
Mothers will be provided with a 30 g portion of caterpillar cereal and will be instructed in the proper technique for preparation. After preparation, mothers will be asked to evaluate five features of the cereal. They will also be asked to provide their overall impression of the cereal. In each category, the evaluation will be assigned a numerical score using a five-part Likert scale, from "like very much" to "dislike very much".
The evaluation will be conducted by the Community Coordinator (CC) who will provide instruction about cereal preparation and administer the evaluative tool. Each evaluation will be conducted confidentially. Mothers will not be aware of the response of other mothers. At the conclusion of a one-week period of feeding (see below), a questionnaire will be administered to assess mothers' attitudes about their willingness to participate in a one-year study of cereal feeding.
We do not intend to evaluate their attitudes about food preparation. The recommended preparation technique of the caterpillar cereal is very similar to preparation of enriched soy cereal in our ongoing complementary feeding study. This involves boiling water and cooking the cereal for approximately three minutes. Although this preparation technique is burdensome, it has not compromised compliance in the ongoing study. Therefore, we would expect a similar response from mothers in the proposed study.
Infant Acceptability
Following the evaluation of maternal acceptability, each mother will be provided with a one-week supply of caterpillar cereal (7 individual packets containing 30 g each). She will be instructed to begin daily feedings on the following day, and to continue until the cereal packets have all been used. The first feeding will occur during a home visit by the CC, who will repeat the preparation instructions, and will observe the first feeding. The CC will return to the home on alternate days throughout the week to reinforce instructions regarding preparation, and to make observations about infant feeding habits. Although frequent visits may influence the likelihood of maternal compliance and hence may mislead investigators about maternal acceptability, it will not effect infant acceptability.
Mothers will be instructed not to feed the cereal to other household members, and will be asked to return uneaten cereal to the original packet for collection by the CC at the end of the week.
On the 8th day, the day following the completion of use of the cereal, the CC will return to the home for the purpose of data collection. The CC will administer a 24-hour dietary recall, and collect all cereal packets. In addition, mothers will be asked questions about the infant's health status.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Feeding group | Experimental | Dietary Supplement: caterpillar cerealThe feeding group will include 20 mother/infant dyads. The infants will be between 8 and 10 months of age. |
Who may qualify
- Ages
- 8 to 10 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Any mother-infant dyad living within each a study community in the Equateur Province. Infants must be 8-10 months of age at the time of recruitment.
Key exclusion criteria (4 listed)
- Infants with minor inter-current illness that may interfere with oral intake
- Infants of multiple gestation births
- Infants with congenital anomalies
- Infants likely to receive free or subsidized complementary foods (or infant formula)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| caterpillar cerealA 30 gram portion of a cereal containing one part dried, ground caterpillar, one part corn flour and small quantities of sugar and palm oil will be evaluated by the mothers and then fed daily for seven days to infants. | Dietary supplement | Feeding group |
Primary outcome
Maternal acceptability
Time frame: Maternal acceptability will be measured on the first day of the trial.
Maternal acceptability will be defined as a median score for each of 5 features (smell, taste, texture, color, consistency, overall impression) of 3 or greater on a 5 point Likert scale.
Infant acceptability
Time frame: Infant acceptability will be measured during the one week study period.
Each mother will be provided with a one-week supply of caterpillar cereal and will be instructed to begin daily feedings for a period of one week. Infant acceptability will be defined as the consumption of greater than 75% of the total cereal allotment by all infants during the last four days of feeding.
1 secondary outcome
Infant tolerance
Time frame: This outcome will be measured throughout the one week intervention.
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 30 Aug 2011.
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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.
Carl L Bose, MD principal investigator
University of North Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing caterpillar cereal in people with Malnutrition and Stunting of Growth, run by University of North Carolina, Chapel Hill at 1 site in Republic of the Congo.
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 4 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 30 Aug 2011. 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 Republic of the Congo. 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?
Maternal acceptability (time frame: Maternal acceptability will be measured on the first day of the trial.). 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 30 Aug 2011.