The Effect of Integrated Prevention and Treatment on Child Malnutrition and Health in Burkina Faso: a Cluster Randomized Intervention Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 2,400
- 试验地点
- 1
- 主要终点
- Screening coverage of acute child malnutrition (proportion of children monthly screened / total number of eligible children (aged 0-17 months)
研究概览
简要总结
Globally, child undernutrition is the underlying cause for 3.1 million deaths of children younger than 5 years. 18.7 million children under five years of age suffer from severe acute malnutrition (SAM) and an additional 33 million children suffer from moderate acute malnutrition, and are at risk of developing SAM
In Sub-Saharan Africa, there is often poor integration between programs to treat child acute malnutrition and programs that focus on the prevention of acute and chronic undernutrition - resulting in many missed opportunities for using prevention platforms to screen and refer SAM children, or for using screening and referral platforms to provide prevention services.
This project will address two critical gaps related to the integration of preventive and treatment programs: 1) screening and treatment of MAM/SAM have not yet been systematically integrated into routine health-center visits or mainstreamed into community outreach programs; and 2) screening programs often do not offer any preventive services for those children found not to be suffering from MAM/SAM at the time of screening; mothers of children identified as non-MAM/SAM case are usually sent home without receiving any health or nutrition inputs and as a result, may fail to come back for screening because they do not see any tangible benefit associated with their participation in the screening. This project will specifically address these gaps by assessing the effect of an integrated approach consisting of higher screening coverage and preventive Behavior Change Communication (BCC) + Small-Quantity Lipid-based Nutrient supplementation (SQ-LNS) on both prevention and treatment of child undernutrition.
详细描述
Because of the intended dual role of BCC/SQ-LNS on child undernutrition in this study - e.g. to help prevent child undernutrition and enhance the coverage of screening, referral and treatment of SAM/MAM, it is necessary to combine two study designs to rigorously evaluate the impact of the proposed intervention and to tease out the contribution of prevention and enhanced coverage/treatment to the overall impact on child malnutrition.
The proposed study will therefore use two types of study designs. The first one is a repeated cross-sectional design that will compare select study outcomes between intervention and control groups at endline, after 24 months of program implementation. A repeated cross-sectional study design among children 0-17 months, at baseline and at study endline (on different children) will be used to assess the impact of the intervention on the prevalence of several outcomes, including the prevalence of MAM/SAM and stunting, the coverage of MAM/SAM screening and maternal ENA/IYCF/WASH knowledge and practices. The second proposed study design entails a longitudinal design whereby individual children will be recruited at birth and followed-up monthly until they reach 18 months of age. We anticipate needing approximately 5 months to recruit the required number of children (estimated at 2,040- 1,020 in the control group and 1,020 in the intervention group). This design will allow us to assess the intervention's effects on the incidence, recovery and recurrence rates of MAM/SAM.
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
- — 至 17 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least one index child 0-17 months of age in the household
- •Mother should be living in the study area since the index child's delivery
- •Singleton infants
排除标准
- •Index child should not present congenital deformations that hamper anthropometric measurements
- •Longitudinal study (n=2,180)
- •Inclusion Criteria:
- •child 0-1.4 months of age;
- •Mother should be living in the study area since the index child's delivery
- •Singleton infants
- •Exclusion Criteria:
- •Congenital malformations that make anthropometric measurements impossible
- •Mother planning to leave the study area in the coming year
- •Children of 1.5 month of age or older at study inclusion
- •WHZ<-2 both at enrollment and at the first follow-up.
结局指标
主要结局
Screening coverage of acute child malnutrition (proportion of children monthly screened / total number of eligible children (aged 0-17 months)
时间窗: monthly from study inclusion at 0 months to 17 months of age and at study endline
* Cross-sectional study * Longitudinal study
Prevalence of acute child malnutrition defined by WHZ<-2 or MUAC <125mm or bilateral pitting edema in children 0-17 months of age
时间窗: After 24 months of program implementation
* Cross-sectional study * To calculate WHZ scores the 2006 WHO growth reference will be used * The MUAC criterion (125mm) is only used for children 6-17months of age
Incidence of child acute malnutrition defined by WHZ<-2 or MUAC<125mm
时间窗: monthly from study inclusion at 0 months to 17 months of age
* Longitudinal study * To calculate WHZ scores the 2006 WHO growth reference will be used
Compliance to treatment of acute malnutrition (% of cases that complete treatment over total admitted)
时间窗: monthly from study inclusion at 0 months to 17 months of age and at study endline
* Cross-sectional study * Longitudinal study
次要结局
- Mean WHZ-score in children 0 -17 months of age(After 24 months of program implementation)
- Mean HAZ-score in children 0-17 months of age(After 24 months of program implementation)
- Relapse rate after treatment of MAM/SAM (proportion WHZ<-2 or MUAC<125mm or bilateral pitting edema after discharge from MAM or SAM treatment program over total number of children treated)(monthly from inclusion at 0 months to 17 months of age)
- Mean hemoglobin concentration in children 3-17 months of age(After 24 months of program implementation)
- Prevalence of child anemia (Hb concentration<10g/dL) in children 3 - 17 months of age(After 24 months of program implementation)
- Prevalence of severe acute child malnutrition defined by a WHZ<-3 or bilateral pitting edema or a MUAC<115mm in children 0-17 months of age(After 24 months of program implementation)
- Caregiver's knowledge and practices related to Infant and Young Child Feeding (IYCF), Essential Nutrition Actions (ENA) and Water, Sanitation and Hygiene (WASH)(After 24 months of program implementation)
- Prevalence of child stunting defined by HAZ<-2 in children 0-17 months of age(After 24 months of program implementation)
- Mean mid-upper arm circumference in children 0-17 months of age(After 24 months of program implementation)
- Prevalence of severe stunting defined by a HAZ<-3 in children 0-17 months of age(After 24 months of program implementation)
- Mid-upper arm circumference gain (MUAC increment/month)(monthly from inclusion at 0 months to 17 moths of age)
- Infant morbidity (acute respiratory infections, fever, malaria (RDT), vomiting, diarrhea)(monthly from inclusion at 0 months to 17 moths of age)
- Linear growth velocity (HAZ increment/month)(monthly from inclusion at 0 months to 17 months of age)
- Incidence of child stunting defined by HAZ<-2 in children from 0 to 17 months(monthly from inclusion at 0 months to 17 months of age)
- Ponderal growth velocity (WHZ increment/month)(monthly from inclusion at 0 months to 17 months of age)
- Weight gain (weight increment/month)(monthly from inclusion at 0 months to 17 months of age)