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Food Aid Quality Review: Feasibility and Acceptability Study of Corn Soy Blend and Fortified Vegetable Oil in Malawi (FAQR-Malawi)

2015年2月2日 更新者:Tufts University

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

6811

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

6个月 至 4年 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

描述

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:

-None

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Receive extra oil
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.
无干预:Control-No extra oil received
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.
实验性的:Receives behavior changed messages on CSB package
Group receiving CSB repackaged into 2kg packages with messages on package on how to prepare. Only in Phase II.
无干预:Control-No repackaged CSB

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in average percent of oil by volume in the porridge as prepared
大体时间: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.
Baseline (July 2013), Phase I (October 2013) 3 months, Phase II (January 2014) 6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Beatrice L Rogers, PhD、Tufts University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年7月1日

初级完成 (实际的)

2014年7月1日

研究注册日期

首次提交

2013年4月22日

首先提交符合 QC 标准的

2013年6月5日

首次发布 (估计)

2013年6月10日

研究记录更新

最后更新发布 (估计)

2015年2月4日

上次提交的符合 QC 标准的更新

2015年2月2日

最后验证

2015年2月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • AID-016-Malawi
  • AFP-C-00-09-00016-00 (其他赠款/资助编号:USAID)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

儿童营养不良的临床试验

Receive extra oil的临床试验

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