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临床试验/NCT04155437
NCT04155437已完成不适用

Assessing the Feasibility of Integrating a Package of Maternal Nutrition Interventions Into Antenatal Care Services in Burkina Faso: A Cluster-Randomized Evaluation

International Food Policy Research Institute2 个研究点 分布在 1 个国家目标入组 8,110 人开始时间: 2019年11月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
8,110
试验地点
2
主要终点
Dietary diversity during pregnancy

研究概览

简要总结

Alive & Thrive (A&T) is an initiative that supports the scaling up of nutrition interventions to save lives, prevent illnesses, and contribute to healthy growth and development through improved maternal nutrition, breastfeeding and complementary feeding practices. In Burkina Faso, A&T developed an intensive package of maternal nutrition interventions to be integrated into existing ANC services delivered through government health facilities that align with the latest global evidence. These included intensified counseling and support on dietary diversity and quality during pregnancy, iron-folic acid (IFA) supplements consumption, importance of ANC and increasing the number of visits, adequate weight-gain monitoring, and early initiation of and exclusive breastfeeding. The evaluation used a two-arm cluster-randomized, non-masked trial design, consisting of two cross-sectional surveys of pregnant and recently delivered women (i.e. with a child under 6 months of age) in 2019 and 2021.

详细描述

Routine antenatal care (ANC) offers opportunities to receive a broad range of health promotion and prevention services including support for adequate nutritional care for pregnant women and their newborns, and any required medical treatment. In 2016, World Health Organization (WHO) updated its guidelines on ANC with a high priority placed on nutrition interventions. These guidelines also recommended increasing the number of ANC from at least four to eight contacts to improve women's positive experience of care and to reduce perinatal morbidity and mortality. Following these new recommendations, the government of Burkina Faso is working with WHO and other partners to revise the national guidelines on ANC and test elements of the essential core package of routine ANC needed by women throughout pregnancy.

A&T Burkina Faso, developed an intensive package of maternal nutrition interventions to be integrated into existing ANC services delivered through government health facilities that align with the latest global evidence. These included intensified counseling and support on dietary diversity and quality during pregnancy, iron-folic acid (IFA) supplements consumption, importance of ANC and increasing the number of visits, adequate weight-gain monitoring, and early initiation of and exclusive breastfeeding. IFPRI tested the feasibility of the behavior-change interventions and examined their impacts on pregnant women's health and nutrition practices and breastfeeding practices of recently delivered women, compared with standard antenatal care services provided in control areas.

The study was designed as a two-arm cluster-randomized, non-masked trial, consisting of two cross-sectional surveys at baseline and endline. The unit of randomization was the health and social promotion center (CSPS, Centre de Santé et de Promotion Social in French) catchment area. 40 CSPS in Boucle du Mouhoun and 40 CSPS in Hauts-Bassins were randomly assigned to intervention/control. A baseline cluster/facility-level and household survey took place in November-December 2019. Soon after the completion of the baseline survey, the interventions were implemented at the CSPS and villages within the intervention areas for approximately 10 months (less than 1 year, caused by brief service interruptions in March-April 2020 due to the COVID-19 pandemic). The endline survey took place in January-March 2021.

The overall study objective is to evaluate the feasibility of integrating locally relevant maternal nutrition interventions into ANC services provided by the government health system and their impact on diet quality and quantity and utilization of nutrition interventions during pregnancy.

The implementation research study addresses three research questions:

研究设计

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

入排标准

年龄范围
15 Years 至 49 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Currently pregnant or recently delivered with a child 0-5.9 months of age
  • Residency in the health facility catchment area
  • Informed consent

排除标准

  • Age <15 years or >49 years

结局指标

主要结局

Dietary diversity during pregnancy

时间窗: Approximately 16 months after baseline in a cross-sectional endline survey

Mean number of food groups consumed by pregnant women on the day preceding the interview.

Minimum dietary diversity during pregnancy

时间窗: Approximately 16 months after baseline in a cross-sectional endline survey

Proportion of pregnant women who consumed 5 or more food groups on the day preceding the interview.

Consumption of iron-folic acid tablets during pregnancy

时间窗: Approximately 16 months after baseline in a cross-sectional endline survey

Mean number of IFA tablets consumed during last pregnancy by recently delivered women with a child 0-5.9 months of age.

Consumption of 90+ iron-folic acid tablets during pregnancy

时间窗: Approximately 16 months after baseline in a cross-sectional endline survey

Proportion of women who consumed 90+ IFA tablets during last pregnancy by recently delivered women with a child 0-5.9 months of age.

次要结局

  • Use of ANC services during pregnancy(Approximately 16 months after baseline in a cross-sectional endline survey)
  • Exposure to nutrition interventions during ANC(Approximately 16 months after baseline in a cross-sectional endline survey)
  • Availability of ANC service supports(Approximately 16 months after baseline in a cross-sectional endline survey)
  • Health worker knowledge of IFA supplementation, dietary diversity, weight gain during pregnancy, and early and exclusive breastfeeding.(Approximately 16 months after baseline in a cross-sectional endline survey)
  • Early initiation of breastfeeding(Approximately 16 months after baseline in a cross-sectional endline survey)
  • Micronutrient, protein and energy adequacy during pregnancy(Approximately 16 months after baseline in a cross-sectional endline survey)
  • Women's knowledge of maternal nutrition and breastfeeding(Approximately 16 months after baseline in a cross-sectional endline survey)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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