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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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

6811

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

6ヶ月~4年 (子)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
介入なし: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.
実験的: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.
介入なし:Control-No repackaged CSB

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in average percent of oil by volume in the porridge as prepared
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Beatrice L Rogers, PhD、Tufts University

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2013年7月1日

一次修了 (実際)

2014年7月1日

試験登録日

最初に提出

2013年4月22日

QC基準を満たした最初の提出物

2013年6月5日

最初の投稿 (見積もり)

2013年6月10日

学習記録の更新

投稿された最後の更新 (見積もり)

2015年2月4日

QC基準を満たした最後の更新が送信されました

2015年2月2日

最終確認日

2015年2月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • AID-016-Malawi
  • AFP-C-00-09-00016-00 (その他の助成金/資金番号:USAID)

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