Child MalnutritionFAQR-MalawiNCT01873196
Food Aid Quality Review: Feasibility and Acceptability Study of Corn Soy Blend and Fortified Vegetable Oil in Malawi
A study testing Receive extra oil and Receives behavior changed messages on CSB package in people with Child Malnutrition, run by Tufts University at 1 site in Malawi.
Trial summary
This research will test alternative methods of ensuring compliance with recommended preparation and targeting of supplementary foods for malnourished children under five years of age. The hypotheses that the proposed study intends to test are as follows: 1. Read more about this study
- Who is it for?
- Ages 6 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Child Malnutrition
- What is being tested?
- Receive extra oil and Receives behavior changed messages on CSB package
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,811 participants
- Where
- 1 siteMalawi
- Study dates
- Jul 2013to Jul 2014
- 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 6 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child enrolled in Supplementary Feeding Program (SFP) to receive ration (CSB13 and FVO) from 1 of the 16 Food Distribution Points
- Child has an SFP ration card
- Subject's whose mother/caretaker or CSB preparer was contacted to participate in taste test FGD
- Subject's whose mother/caretaker is voluntarily willing to consent to their child's participation in taste tests
- Beneficiary Mother/Caretaker enrolled in Supplementary Feeding Program (SFP) to receive ration (CSB13 and FVO) for her child from 1 of the 16 Food Distribution Points
- Beneficiary Child has an SFP ration card
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- Beneficiary Mother/Caretaker has no age restrictions for inclusion (Note: Mothers/caretakers or CSB preparers will be asked to participate regardless of age and consented appropriately)
- Subject who is voluntarily willing to participate by signing the consent form (or if minor, adult is willing to sign on their behalf). Note: This should will only come after the subject has been educated on all that appertains to their her involvement in this study, the consent script read aloud for them and given the chance to make her own non-coerced, non-persuaded and autonomous decision.
- Lead mother who covers the catchment area of the selected 16 FDP's
- Lead mother has been present during the program change period
- Subject who is voluntarily willing to participate by signing the consent form
- Health Care Workers serving within the catchment area for the 16 FDPs
- Health Care Worker has been present during the study period
- Subject who is voluntarily willing to participate by signing the consent form
- All staff members from Catholic Relief Services, Africare, Save the Children, Project Concern International (PCI)
- Subject who is voluntarily willing to participate by signing the consent form
- Store owner/market vendor in study districts (i.e. Machinga, Balaka, Chiradzulu and Mulanje districts) who trades in the relevant products (food vendors)
- Subject who is voluntarily willing to participate by signing the consent form
Who cannot join
- All children enrolled in the SFP in the selected program change FDPs are eligible
- Beneficiary Mothers/Caretakers (Mothers/Caretakers of Children Under five years old,U5):
- Beneficiary Mothers/Caretakers who were interviewed once for this study will not be interviewed a second time during a later Phase of the study.
- Care Group Lead Mothers
- None
- Health Care Workers (Health Surveillance Agents, Health Promoters, Resource Persons)
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- -None
- PVO Staff Members
- PVO Staff members who joined too recently to have experience of the program change Store Owners/Market Vendor
- Vendors who do not sell food.
Trial locations and contacts
1 site in 1 country.
About this study
This research will test alternative methods of ensuring compliance with recommended preparation and targeting of supplementary foods for malnourished children under five years of age.
The hypotheses that the proposed study intends to test are as follows:
- With appropriate behavior change communication (BCC) and social support, and with provision of CSB and FVO in the correct proportions, it is possible to get women to prepare CSB with oil in the recommended ratio of 100:30, and in quantities just sufficient for the target child.
- Providing CSB to Beneficiary Mothers/Caretakers pre-packaged bags of 2 kg with appropriate messaging and with instructions to direct the food to children and to prepare the CSB with oil in the recommended ratio and feed as instructed will result in better compliance.
Read the detailed description
The first stage of the study involves working with the procurement and program staff to ensure that oil and CSB will be available at the same time in sufficient quantities and can be distributed together. We will work with program staff and outside consultants (if needed) to develop locally acceptable recipes for CSB plus oil. A sample of communities with MCHN programs will be chosen, and the intervention (consistent provision of CSB with oil, teaching of recipes using CSB with oil, appropriate behavioral support) implemented. Tufts and locally contracted researchers will interview program staff involved in procurement and supply chain management as well as program staff, and beneficiaries, to assess the feasibility and acceptability of the provision of CSB with oil, and identify barriers and problems. This stage is expected to take six months.
In the second stage of the study, the CSB will be distributed in new, smaller packages in half the sample communities, with the other half continuing with their normal distribution. In preparation for this stage, during the first stage, Tufts researchers will arrange for the production/packaging of a sufficient supply of CSB in the new packages, and will contract with local communications specialists to develop appropriate messages, so these will be available in time for the second stage of the study. Tufts and locally contracted researchers will collect information from program staff on their perception of the feasibility and impact of the change, and will interview beneficiaries to determine how they use the CSB and whether their use changes with the change in packaging/messaging. We may track the effect on intrahousehold sharing through self report of consumption among family members. This stage will last about six months, with data collection from beneficiaries conducted before and up to six months after the start of the intervention.
In addition to interviews and focus group discussions, we will collect samples of porridge as prepared in order to assess the proportion of oil, and we will conduct market observations to determine whether increased distribution of oil affects availability and price in the market, and whether market access affects beneficiary mothers' compliance with recommended preparation method. We will conduct a small number of in-home observations to observe beneficiary mothers' practices with respect to storage, preparation, and feeding of children, of which they might not be aware.
The key outcomes of the study are the proportion of oil in the CSB porridge as prepared, and the percent of beneficiary mothers who meet the standard for the oil : CSB ratio.
- Conditions
- Child Malnutrition
- Being tested
- Receive extra oil, Receives behavior changed messages on CSB package
- Medical subject headings
- Child Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Receive extra oilBehavioural
Receives behavior changed messages on CSB packageBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Receive extra oil | Experimental | This arm will receive enough oil to prepare the CSB they receive in the newly recommended proportion of 100g CSB: 30g oil. They will receive education and instructions on the new method of preparation. Receives: Behavioral: Receive extra oil |
| Control-No extra oil received | No intervention | This group will continue to receive only 1L of oil with their CSB has they already have been. They also will not receive any new education. |
| Receives behavior changed messages on CSB package | Experimental | Group receiving CSB repackaged into 2kg packages with messages on package on how to prepare. Only in Phase II. Receives: Behavioral: Receives behavior changed messages on CSB package |
| Control-No repackaged CSB | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in average percent of oil by volume in the porridge as prepared
Having samples of prepared porridge taken from beneficiary mothers analyzed for percentage of oil content. This will allow us to know if the mothers are preparing the porridge in the appropriate ration of 100g CSB: 30g oil.
Measured: Baseline (July 2013), Phase I (October 2013) 3 months, Phase II (January 2014) 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child MalnutritionStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,811 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Responsible party
- Sponsor
- Investigators
- Beatrice L Rogers, PhD, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01873196
- Sponsor's protocol ID
- AID-016-Malawi
- Other IDs
- AFP-C-00-09-00016-00
- Acronym
- FAQR-Malawi
- Status last verified
- Feb 2015
- First submitted
- 22 Apr 2013
- Last updated
- 4 Feb 2015
- Results posted
- No
Publications
Wilner L, Suri DJ, Langlois BK, Walton SM, Rogers BL. Effective delivery of social and behavior change communication through a Care Group model in a supplementary feeding program. J Health Popul Nutr. 2017 Sep 12;36(1):34. doi: 10.1186/s41043-017-0111-3.
PubMed 28899434
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Aid Quality Review: Feasibility and Acceptability Study of Corn Soy Blend and Fortified Vegetable Oil in Malawi
- ClinicalTrials.gov ID
- NCT01873196
- Acronym / sponsor ID
- FAQR-Malawi / AID-016-Malawi
- Conditions
- Child Malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,811 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Study start
- Jul 2013
- Primary completion
- Jul 2014 (actual)
- First posted
- 10 Jun 2013 (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.
This research will test alternative methods of ensuring compliance with recommended preparation and targeting of supplementary foods for malnourished children under five years of age.
The hypotheses that the proposed study intends to test are as follows:
- With appropriate behavior change communication (BCC) and social support, and with provision of CSB and FVO in the correct proportions, it is possible to get women to prepare CSB with oil in the recommended ratio of 100:30, and in quantities just sufficient for the target child.
- Providing CSB to Beneficiary Mothers/Caretakers pre-packaged bags of 2 kg with appropriate messaging and with instructions to direct the food to children and to prepare the CSB with oil in the recommended ratio and feed as instructed will result in better compliance.
Detailed description
The first stage of the study involves working with the procurement and program staff to ensure that oil and CSB will be available at the same time in sufficient quantities and can be distributed together. We will work with program staff and outside consultants (if needed) to develop locally acceptable recipes for CSB plus oil. A sample of communities with MCHN programs will be chosen, and the intervention (consistent provision of CSB with oil, teaching of recipes using CSB with oil, appropriate behavioral support) implemented. Tufts and locally contracted researchers will interview program staff involved in procurement and supply chain management as well as program staff, and beneficiaries, to assess the feasibility and acceptability of the provision of CSB with oil, and identify barriers and problems. This stage is expected to take six months.
In the second stage of the study, the CSB will be distributed in new, smaller packages in half the sample communities, with the other half continuing with their normal distribution. In preparation for this stage, during the first stage, Tufts researchers will arrange for the production/packaging of a sufficient supply of CSB in the new packages, and will contract with local communications specialists to develop appropriate messages, so these will be available in time for the second stage of the study. Tufts and locally contracted researchers will collect information from program staff on their perception of the feasibility and impact of the change, and will interview beneficiaries to determine how they use the CSB and whether their use changes with the change in packaging/messaging. We may track the effect on intrahousehold sharing through self report of consumption among family members. This stage will last about six months, with data collection from beneficiaries conducted before and up to six months after the start of the intervention.
In addition to interviews and focus group discussions, we will collect samples of porridge as prepared in order to assess the proportion of oil, and we will conduct market observations to determine whether increased distribution of oil affects availability and price in the market, and whether market access affects beneficiary mothers' compliance with recommended preparation method. We will conduct a small number of in-home observations to observe beneficiary mothers' practices with respect to storage, preparation, and feeding of children, of which they might not be aware.
The key outcomes of the study are the proportion of oil in the CSB porridge as prepared, and the percent of beneficiary mothers who meet the standard for the oil : CSB ratio.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Receive extra oil | Experimental | Behavioral: Receive extra oilThis arm will receive enough oil to prepare the CSB they receive in the newly recommended proportion of 100g CSB: 30g oil. They will receive education and instructions on the new method of preparation. |
| Control-No extra oil received | No intervention | –This group will continue to receive only 1L of oil with their CSB has they already have been. They also will not receive any new education. |
| Receives behavior changed messages on CSB package | Experimental | Behavioral: Receives behavior changed messages on CSB packageGroup receiving CSB repackaged into 2kg packages with messages on package on how to prepare. Only in Phase II. |
| Control-No repackaged CSB | No intervention | – |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (18 listed)
- Child enrolled in Supplementary Feeding Program (SFP) to receive ration (CSB13 and FVO) from 1 of the 16 Food Distribution Points
- Child has an SFP ration card
- Subject's whose mother/caretaker or CSB preparer was contacted to participate in taste test FGD
- Subject's whose mother/caretaker is voluntarily willing to consent to their child's participation in taste tests
- Beneficiary Mother/Caretaker enrolled in Supplementary Feeding Program (SFP) to receive ration (CSB13 and FVO) for her child from 1 of the 16 Food Distribution Points
Key exclusion criteria (10 listed)
- All children enrolled in the SFP in the selected program change FDPs are eligible
- Beneficiary Mothers/Caretakers who were interviewed once for this study will not be interviewed a second time during a later Phase of the study.
- Care Group Lead Mothers
- None
- Health Care Workers (Health Surveillance Agents, Health Promoters, Resource Persons)
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 |
|---|---|---|
| Receive extra oil | Behavioural | Receive extra oil |
| Receives behavior changed messages on CSB package | Behavioural | Receives behavior changed messages on CSB package |
Primary outcome
Change in average percent of oil by volume in the porridge as prepared
Time frame: Baseline (July 2013), Phase I (October 2013) 3 months, Phase II (January 2014) 6 months
Having samples of prepared porridge taken from beneficiary mothers analyzed for percentage of oil content. This will allow us to know if the mothers are preparing the porridge in the appropriate ration of 100g CSB: 30g oil.
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 4 Feb 2015.
- Derived from this study: PubMed 28899434Wilner L, Suri DJ, Langlois BK, Walton SM, Rogers BL. Effective delivery of social and behavior change communication through a Care Group model in a supplementary feeding program. J Health Popul Nutr. 2017 Sep 12;36(1):34. doi: 10.1186/s41043-017-0111-3.
- Food Aid Quality ReviewLink provided by the sponsor.
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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.
Beatrice L Rogers, PhD principal investigator
Tufts University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Receive extra oil and Receives behavior changed messages on CSB package in people with Child Malnutrition, run by Tufts University at 1 site in Malawi.
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 18 inclusion and 10 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 4 Feb 2015. 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 Malawi. 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?
Change in average percent of oil by volume in the porridge as prepared (time frame: Baseline (July 2013), Phase I (October 2013) 3 months, Phase II (January 2014) 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01873196, which also lists 1 linked publication.
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 4 Feb 2015.