Child Malnutrition Clinical Trial
— FAQR-MalawiOfficial title:
Food Aid Quality Review: Feasibility and Acceptability Study of Corn Soy Blend and Fortified Vegetable Oil in Malawi
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. 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.
2. 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.
Status | Completed |
Enrollment | 6811 |
Est. completion date | |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Months to 59 Months |
Eligibility |
All Beneficiary Mothers/Caretakers receiving supplementary food for their children at the
selected FDPs implementing a program change or the control FDPs , are considered part of
the subject pool. All beneficiaries will be receiving a program change (consistent with
additional oil ration and education on preparation in Phase I, and repackaged CSB in Phase
II) in the selected FDPs. Participation in individual interviews, focus group discussions,
and observations constitutes subject participation. Subject Categories - Beneficiary Children that are part of the taste tests in preparation for Phase I - Beneficiary Mothers/Caretakers that participate in interviews, focus group discussions, and in home observations - Care Group Lead Mothers that participate in individual interviews and FGD - Health Care Workers that participate in individual interviews - PVO staff members that participate in individual interviews - Store owners/Market Vendors that participate in individual interviews Beneficiary Children (Children Under five years old,U5): Inclusion Criteria: - 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 Exclusion Criteria: - 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): Inclusion Criteria: - 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 - 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. Exclusion Criteria: - 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 Inclusion Criteria: - 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 Exclusion Criteria: - None Health Care Workers (Health Surveillance Agents, Health Promoters, Resource Persons) Inclusion Criteria: - 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 Exclusion Criteria: PVO Staff Members Inclusion Criteria: - 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 Exclusion Criteria: - PVO Staff members who joined too recently to have experience of the program change Store Owners/Market Vendor Inclusion Criteria: - 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 Exclusion Criteria: - Vendors who do not sell food. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Tufts University | United States Agency for International Development (USAID) |
Malawi,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline (July 2013), Phase I (October 2013) 3 months, Phase II (January 2014) 6 months | No |
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