The Effect of Integrated Prevention and Treatment on Child Malnutrition and Health in Mali: a Cluster Randomized Intervention Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 2,304
- 试验地点
- 1
- 主要终点
- Compliance to treatment of acute malnutrition (% of cases that complete treatment over total admitted)
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 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. These cross-sectional surveys among children 6-23 months, at baseline and after 24 months (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 study design entails a longitudinal design whereby individual children will be recruited at 6 months of age and followed-up monthly until they reach 24 months of age.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
- 6 Months 至 23 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least one index child 6-23 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
- •Inclusion Criteria:
- •Child 6-6.9 months of age;
- •Child with WHZ>-2 and MUAC>125 mm and no bilateral pitting edema
- •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 are in the coming year
研究组 & 干预措施
Control
Behavior change communication (BCC) on Essential Nutrition Actions (ENA), Infant and Young Child Feeding (IYCF) and Water, sanitation and hygiene (WASH) is provided during monthly meetings for children 6-23 months of age
干预措施: Child's health and nutrition topics (Behavioral)
PROMIS intervention
- Behavior change communication (BCC) on Essential Nutrition Actions (ENA), Infant and Young Child Feeding (IYCF) and Water, sanitation and hygiene (WASH) is provided during monthly meetings for children 6-23 months of age
- Caregivers with children 6-23 months of age that attend Counselling meetings will be provided with a monthly dose of SQ-LNS (20g/day)
干预措施: Small-Quantity Lipid-based nutrient supplement (Dietary Supplement)
PROMIS intervention
- Behavior change communication (BCC) on Essential Nutrition Actions (ENA), Infant and Young Child Feeding (IYCF) and Water, sanitation and hygiene (WASH) is provided during monthly meetings for children 6-23 months of age
- Caregivers with children 6-23 months of age that attend Counselling meetings will be provided with a monthly dose of SQ-LNS (20g/day)
干预措施: Child's health and nutrition topics (Behavioral)
结局指标
主要结局
Compliance to treatment of acute malnutrition (% of cases that complete treatment over total admitted)
时间窗: monthly from study inclusion at 6 months to 23 months of age and at study endline
* Cross-sectional study * Longitudinal study
Screening coverage of acute child malnutrition (proportion of children monthly screened / total number of eligible children (aged 6-23 months)
时间窗: monthly from study inclusion at 6 months to 23 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 6-23 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
Incidence of child acute malnutrition defined by WHZ<-2 or MUAC<125mm
时间窗: Monthly from study inclusion at 6 months to 23 months of age
* Longitudinal study * To calculate WHZ scores the 2006 WHO growth reference will be used
次要结局
- Mid-Upper Arm Circumference gain (MUAC increment /month)(monthly from inclusion at 6 months to 23 months)
- Prevalence of child stunting defined by HAZ<-2 in children 6-23 months of age(After 24 months of program implementation)
- Mean hemoglobin concentration at endline in children 6-23 months of age(After 24 months of program implementation)
- Ponderal growth velocity (WHZ increment/month)(monthly from inclusion at 6 months to 23 months)
- Infant morbidity (acute respiratory infections, fever, malaria (RDT), vomiting, diarrhea)(monthly from inclusion at 6 months to 23 months)
- Prevalence of Severe Acute Malnutrition defined by a WHZ<-3 or bilateral pitting edema or a MUAC<115mm(After 24 months of program implementation)
- Mean Mid-Upper Arm Circumference in children 6-23 months of age(After 24 months of program implementation)
- Incidence of child stunting defined by HAZ<-2 in children from 6 to 23 months of age(monthly from inclusion at 6 months to 23 months of age)
- 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 a total number of children treated(monthly from inclusion at 6 months to 23 months)
- Mean WHZ-score in children 6-23 months of age(After 24 months of program implementation)
- Prevalence of child anemia (Hb concentration<11g.dL-1) at endline in children 6-23 months of age(After 24 months of program implementation)
- Mean HAZ-score in children 6-23 months of age(After 24 months of program implementation)
- Prevalence of severe stunting defined by a HAZ<-3 in children 6-23 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)
- Linear growth velocity (HAZ increment/month)(monthly from inclusion at 6 months to 23 months)
- Weight gain (weight increment/month)(monthly from inclusion at 6 months to 23 months)
- Child development (motor, language and personal-social development)(After 24 months of program implementation)