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临床试验/NCT03073590
NCT03073590已完成不适用

Improving Anemia Status of Female Garment Workers in Bangladesh: An Evaluation of Pilot Intervention in Four Factories

International Centre for Diarrhoeal Disease Research, Bangladesh2 个研究点 分布在 1 个国家目标入组 1,310 人开始时间: 2016年1月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,310
试验地点
2
主要终点
Changes from Baseline Anemia level at 10 months

研究概览

简要总结

The current study is aimed at evaluating nutrition interventions to be implemented for improving health and nutritional status of female garments workers in 4 selected garment factories in Bangladesh. The interventions will attempt to increase either energy intake and or iron intake by female garments workers and expected to implement the interventions as planned:

  1. Provision of a once weekly iron/folate supplement, and nutritionally improved, daily hot lunch including multi-nutrient fortified rice plus a nutrition and health behavior change communications (BCC) program in intervention factory compared with a control factory which will provide regular lunch meal plus a nutrition and health behavior change communications (BCC) program for 10 months
  2. Provision of a twice weekly iron/folate supplement plus a nutrition and health BCC program in an intervention factory compared with a control factory with only nutrition and health BCC program for 10 months; on the following outcomes:
  • Prevalence of anemia
  • Nutrition knowledge and practices as per key messages of the BCC program
  • Worker satisfaction with the modified lunch and/or iron/folate supplementation, and the BCC program

详细描述

Research Design and Methods Impact Survey Design To determine the impact of this program on the main outcomes (i.e., prevalence of anemia and dietary intake practices) we will use a quasi-experimental, controlled, pre-post design for both sets of interventions (Figure 1).

We are using a quasi-experimental design as it is not possible to identify a large pool of factories from which to randomly sample and assign factories to a control or intervention group. To minimize possible selection bias, we will:

i. To the extent possible, factories will be selected based on specified criteria, to minimize major differences in response to the intervention among them (as described in selection of factories section).

ii. Select individual women for pre-post studies based on matching or equivalence on key characteristics (eg, age); iii. Use difference-in-difference analysis to test impacts.

Intervention Description Two types of interventions will be tested against controls in a total of 4 factories. Among factories that already provide a hot lunch to workers, one intervention and one control factory will be selected, and among factories that do not provide hot lunches, one intervention and one control factory will be selected.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 42 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Adult Non-pregnant female garment worker between 18-42 years of age from selected factories who are present and give consent for interview

排除标准

  • Eligible participants who decline consent
  • Eligible participants suffering from any known chronic illnesses

研究组 & 干预措施

Intervention with lunch

Experimental

Intervention factory with hot lunch program A. Nutritionally enhanced lunch meal program B. Once weekly iron/folate supplement C. Behavior change communications program

干预措施: Intervention factory with hot lunch (Combination Product)

Control with lunch

Active Comparator

Control factory with lunch program A. Regular lunch meal program B. Behavior change communications program

干预措施: Control factory with lunch program (Combination Product)

Intervention without lunch

Experimental

Intervention factory without lunch program A. Twice weekly provision of iron/folate supplements B. Enhanced behavior change communications program

干预措施: Intervention factory without lunch program (Combination Product)

Control without lunch

Active Comparator

Control factory without lunch program A. Behavior change communications program

干预措施: Control factory without lunch program (Behavioral)

结局指标

主要结局

Changes from Baseline Anemia level at 10 months

时间窗: up to 12 months

Anemia will be assessed by measuring hemoglobin in capillary blood samples using portable HemoCue machine at baseline after enrolment and at the end of 10 months in female garment workers. Single finger prick method will be used to assess anemia status in field. The cut-off levels of haemoglobin that are considered to define anemia: \<110 g/L for pregnant and \<120 g/L for non-pregnant non-lactating or lactating women as the survey areas are at the sea level.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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