Impact Evaluation of Integrated Interventions to Reduce Child Wasting in Mali
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9,797
- 试验地点
- 1
- 主要终点
- Prevalence of relapse after discharge from CMAM treatment (cohort 3).
研究概览
简要总结
The IRAM MALI impact evaluation uses a cluster-randomized controlled study design to assess the impact of the package of integrated interventions aimed at reducing the longitudinal prevalence of wasting by reducing the incidence of child wasting, enhancing the recovery/cure rate from wasting treatment and reducing the relapse rate determined three months after post-treatment recovery from wasting. These interventions include, among other things, strengthening of community care groups (NASGs); home visits with delivery of behavioral change communication about nutrition, health and hygiene (WASH) for young children; distribution of a preventive nutritional supplement; and improved coverage of wasting screening (family MUAC and community screening), management, adherence to treatment and prevention of relapse in the health district of Koutiala, Sikasso region, Mali, West Africa.
详细描述
Progress in reducing the burden of child wasting is hampered by several factors. First, programmatic evidence on how to prevent wasting is limited. There is a growing body of evidence on the effectiveness of dietary supplements in preventing wasting, but little is known about the effectiveness of other strategies such as behavior change communication (BCC) (with or without supplements), cash transfers, or water, hygiene, and sanitation (WASH) interventions. Second, coverage of CMAM (Community based Management of Acute Malnutrition) treatment remains low in many settings. On the supply side, documented constraints include the complexity of current treatment procedures, which disproportionately affects resource-limited settings, and frequent shortages of treatment commodities. On the demand side, low participation in screening and low treatment uptake and adherence are key constraints to effective treatment.
Reducing the burden of wasting effectively requires coordination and integration of sequenced interventions and services along the continuum of care of child wasting including prevention, screening of cases, the timely and adequate treatment of wasted children, and the prevention of relapse of recovered children.
The overall objective of the study is to assess the impact of an integrated package covering the continuum of care of wasting on the longitudinal prevalence of child wasting.
The implementation of these interventions is led by World Vision Mali in collaboration with the health services of the Koutiala health district (Sikasso region, Mali) and UNICEF, and will take place at health center and community level, and includes i) a prevention component combining the strengthening of Nutrition Activity Support Groups (NASG) (who will conduct monthly home visits to deliver behavioral change communication, group counselling sessions and cooking demonstrations) and the distribution of Small-Quantity Lipid-based Nutrient Supplements (SQ-LNS) to children over 6 months of age; ii) a component related to strengthening screening and referral that will involve families (MUAC family approach) and screening by NASGs; iii) a treatment component that includes strengthening the national CMAM protocol currently in vigor in Mali and intensive follow-up of cases under treatment by NASGs to enhance adherence to treatment; and iv) a targetted prevention component through intensified follow-up visits by NASGs and the distribution of SQ-LNS to children who recovered from wasting.
The study, designed as a randomized controlled clustered trial, will allocate 45 health center catchment areas to an intervention (n=22) and comparison group (n=23) and will assess the impact of the integrated package of interventions in three different cohort samples
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 否
入选标准
- •Cohort 1 (prevention cohort):
- •Inclusion criteria are:
- •6-6.9 months of age
- •Singleton
- •The mother must live in the study area from the time of inclusion.
- •The consent of the mother or guardian
排除标准
- •Congenital malformations that make anthropometric measurements impossible.
- •Mother intends to leave the study area before January
- •Cohort 2 (treatment cohort):
- •Inclusion criteria are :
- •The child is enrolled in CMAM treatment program.
- •The child is between 6 and 23 months of age at inclusion
- •Child lives in one of the 45 health center catchment areas in the study area
- •Cohort 3 (relapse cohort):
- •Inclusion criteria are:
- •Child has been successfully treated for wasting and MAM and has been discharged from CMAM treatment program for at least three months
- •The child is between 9 and 17 months at time of measurement.
- •The child is singleton.
- •The mother must live in the study area from the time of inclusion.
- •The consent of the mother or guardian
- •Exclusion criteria are :
- •Congenital malformations that make anthropometric measurements impossible.
- •Mother intends to leave the study area before January 2022.
研究组 & 干预措施
Control
The control group will receive preventive (BCC on child health and nutrition) and screening services from existing unsupervised Nutrition Activity Support Groups (NASGs) without additional support from the IRAM project. Children with wasting are eligible to be enrolled in the existing national Community Management of Acute Malnutrition (CMAM) program.
Intervention
The intervention group will receive the integrated package of interventions that will be delivered by the NASGs.
The NASG platform will be strengthened by the IRAM project by increasing their number proportional to the size of the population of the catchment area they serve and by regular formative supervision by NGO and health center staff.
The package of interventions includes:
- Social and Behavioral Change Communication by NASGs during home visits and group sessions
- Monthly delivery of preventive SQ-LNS to children 6-17 months of age
- Screening and referral of children 6-59 months of age through the introduction of the MUAC family approach (distribution MUAC tapes to families and offering formative supervision by NASGs to enhance measurement quality)
- Cooking demonstrations for complementary foods using nutrientdense foods in the community.
干预措施: Strengthened SBCC (Behavioral)
Intervention
The intervention group will receive the integrated package of interventions that will be delivered by the NASGs.
The NASG platform will be strengthened by the IRAM project by increasing their number proportional to the size of the population of the catchment area they serve and by regular formative supervision by NGO and health center staff.
The package of interventions includes:
- Social and Behavioral Change Communication by NASGs during home visits and group sessions
- Monthly delivery of preventive SQ-LNS to children 6-17 months of age
- Screening and referral of children 6-59 months of age through the introduction of the MUAC family approach (distribution MUAC tapes to families and offering formative supervision by NASGs to enhance measurement quality)
- Cooking demonstrations for complementary foods using nutrientdense foods in the community.
干预措施: Preventive nutritional supplement (Dietary Supplement)
Intervention
The intervention group will receive the integrated package of interventions that will be delivered by the NASGs.
The NASG platform will be strengthened by the IRAM project by increasing their number proportional to the size of the population of the catchment area they serve and by regular formative supervision by NGO and health center staff.
The package of interventions includes:
- Social and Behavioral Change Communication by NASGs during home visits and group sessions
- Monthly delivery of preventive SQ-LNS to children 6-17 months of age
- Screening and referral of children 6-59 months of age through the introduction of the MUAC family approach (distribution MUAC tapes to families and offering formative supervision by NASGs to enhance measurement quality)
- Cooking demonstrations for complementary foods using nutrientdense foods in the community.
干预措施: Family MUAC (Behavioral)
Intervention
The intervention group will receive the integrated package of interventions that will be delivered by the NASGs.
The NASG platform will be strengthened by the IRAM project by increasing their number proportional to the size of the population of the catchment area they serve and by regular formative supervision by NGO and health center staff.
The package of interventions includes:
- Social and Behavioral Change Communication by NASGs during home visits and group sessions
- Monthly delivery of preventive SQ-LNS to children 6-17 months of age
- Screening and referral of children 6-59 months of age through the introduction of the MUAC family approach (distribution MUAC tapes to families and offering formative supervision by NASGs to enhance measurement quality)
- Cooking demonstrations for complementary foods using nutrientdense foods in the community.
干预措施: Active screening by NASGs (Behavioral)
Intervention
The intervention group will receive the integrated package of interventions that will be delivered by the NASGs.
The NASG platform will be strengthened by the IRAM project by increasing their number proportional to the size of the population of the catchment area they serve and by regular formative supervision by NGO and health center staff.
The package of interventions includes:
- Social and Behavioral Change Communication by NASGs during home visits and group sessions
- Monthly delivery of preventive SQ-LNS to children 6-17 months of age
- Screening and referral of children 6-59 months of age through the introduction of the MUAC family approach (distribution MUAC tapes to families and offering formative supervision by NASGs to enhance measurement quality)
- Cooking demonstrations for complementary foods using nutrientdense foods in the community.
干预措施: Intensified followup of children with wasting referred to and enrolled in CMAM treatment (Behavioral)
Intervention
The intervention group will receive the integrated package of interventions that will be delivered by the NASGs.
The NASG platform will be strengthened by the IRAM project by increasing their number proportional to the size of the population of the catchment area they serve and by regular formative supervision by NGO and health center staff.
The package of interventions includes:
- Social and Behavioral Change Communication by NASGs during home visits and group sessions
- Monthly delivery of preventive SQ-LNS to children 6-17 months of age
- Screening and referral of children 6-59 months of age through the introduction of the MUAC family approach (distribution MUAC tapes to families and offering formative supervision by NASGs to enhance measurement quality)
- Cooking demonstrations for complementary foods using nutrientdense foods in the community.
干预措施: Relapse prevention (Behavioral)
Intervention
The intervention group will receive the integrated package of interventions that will be delivered by the NASGs.
The NASG platform will be strengthened by the IRAM project by increasing their number proportional to the size of the population of the catchment area they serve and by regular formative supervision by NGO and health center staff.
The package of interventions includes:
- Social and Behavioral Change Communication by NASGs during home visits and group sessions
- Monthly delivery of preventive SQ-LNS to children 6-17 months of age
- Screening and referral of children 6-59 months of age through the introduction of the MUAC family approach (distribution MUAC tapes to families and offering formative supervision by NASGs to enhance measurement quality)
- Cooking demonstrations for complementary foods using nutrientdense foods in the community.
干预措施: Cooking demonstrations (Behavioral)
结局指标
主要结局
Prevalence of relapse after discharge from CMAM treatment (cohort 3).
时间窗: Up to 4 months, at three months after discharge from CMAM treatment
This indicator is defined as the proportion of children (9-17 months of age) with WLZ-score \<-2 or MUAC \<125 mm or bilateral edema three months after discharge from a CMAM wasting and moderate wasting treatment program
The longitudinal prevalence of wasting in children enrolled at the age of 6 months followed monthly until the end of the study (Cohort 1).
时间窗: Up to 7 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first
This indicator is defined for each child as the number of visits during which nutritional wasting is observed divided by the total number of monthly visits made (by the interviewers).
Recovery rate in children enrolled at [6-23] months of age for up to 3 months of treatment and followed through to discharge (Cohort 2)
时间窗: Up to 3 months, from date of inclusion in CMAM program until the date of recovery or 12th week after inclusion in CMAM program or date of death from any cause, whichever came first
This indicator is defined as the number children who recovered from wasting, MAM and SAM according to national program criteria (WHZ\>-2 and MUAC\>=125mm and absence of bilateral edema for two consecutive visits, within 12 weeks of enrollment in the CMAM program) divided by the total number of treatment results recorded.
次要结局
- Longitudinal prevalence of SAM (cohort 1)(Up to 7 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
- Incidence of Wasting, MAM and SAM (cohort 1)(Up to 7 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
- Hemoglobin concentration of children (cohort 1)(Up to 7 months, from date of enrolment until the date of last documented progressio)
- Prevalence of anaemia (cohort 1)(Up to 7 months, from date of enrolment until the date of last documented progressio)
- Child weight (cohort 1)(Up to 7 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
- Longitudinal prevalence of child morbidity (cohort 1)(Up to 7 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
- Parental knowledge of nutrition, WASH, and health best practices (cohort 1)(Up to 7 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
- Longitudinal prevalence of Introduction of (semi) solid and soft complementary foods (cohort 1)(Up to 7 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
- MUAC growth rate (cohort 1)(Up to 7 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
- Longitudinal prevalence of infant and young child minimum acceptable diet (cohort 1)(Up to 7 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
- Prevalence of infant and young child consumption of iron-rich or iron-fortified foods (cohort 3)(Up to 4 months, at three months after discharge from CMAM treatment)
- Adoption of practices recommended by NASGs (cohort 3)(Up to 4 months, at three months after discharge from CMAM treatment)
- Treatment outcomes (drop-out, death, transfer, non-response rates) (cohort 2)(Up to 3 months, from date of inclusion in CMAM program until the date of recovery or 12th week after inclusion in CMAM program or date of death from any cause, whichever came firs)
- Weight-for-length Z-score (cohort 3)(Up to 4 months, at three months after discharge from CMAM treatment)
- Length-for-age Z-score (cohort 3)(Up to 4 months, at three months after discharge from CMAM treatment)
- Child Stunting (cohort 3)(Up to 4 months, at three months after discharge from CMAM treatment)
- Hemoglobin concentration of children (cohort 3)(Up to 4 months, at three months after discharge from CMAM treatment)
- Longitudinal prevalence of MAM (cohort 1)(Up to 7 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
- Child length (cohort 1)(Up to 7 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
- Linear growth rate (cohort 1)(Up to 7 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
- Length-for-age Z-score (cohort 1)(Up to 7 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
- Prevalence of child stunting (cohort 1)(Up to 7 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
- Longitudinal wasting screening coverage (cohort 1)(Up to 7 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
- Referral rate of positive screenings (cohort 1)(Up to 7 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
- Early Child development (cohort 1)(Up to 7 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
- Ponderal growth rate (cohort 1)(Up to 7 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
- Longitudinal prevalence of infant and young child minimum meal frequency (cohort 1)(Up to 7 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
- Longitudinal prevalence of continuous breastfeeding (cohort 1)(Up to 7 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
- Child length(cohort 3)(Up to 4 months, at three months after discharge from CMAM treatment)
- Longitudinal prevalence of minimum dietary diversity of infant and young children (cohort 1)(Up to 7 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
- Longitudinal prevalence of infant and young child consumption of iron-rich or iron-fortified foods (cohort 1)(Up to 7 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
- Vaccination coverage (cohort 1)(Up to 7 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
- Prevalence of anemia (cohort 3)(Up to 4 months, at three months after discharge from CMAM treatment)
- Prevalence of infant and young child minimum acceptable diet (cohort 3)(Up to 4 months, at three months after discharge from CMAM treatment)
- Adoption of practices recommended by NASGs (cohort 1)(Up to 7 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
- Weight-for-length Z-score and MUAC at enrollment in CMAM (cohort 2)(Up to 7 months, at the date of inclusion in CMAM program)
- Longitudinal prevalence of childhood morbidity (cohort 2)(Up to 3 months, from date of inclusion in CMAM program until the date of recovery or 12th week after inclusion in CMAM program or date of death from any cause, whichever came first)
- Mid-Upper Arm Circumference of children (cohort 3)(Up to 4 months, at three months after discharge from CMAM treatment)
- Prevalence of readmission (cohort 3)(Up to 4 months, at three months after discharge from CMAM treatment)
- Longitudinal prevalence of childhood morbidity (cohort 3)(Up to 4 months, at three months after discharge from CMAM treatment)
- Duration of CMAM treatment (cohort 2)(Up to 3 months, from date of inclusion in CMAM program until the date of recovery or 12th week after inclusion in CMAM program or date of death from any cause, whichever came first)
- Treatment adherence (cohort 2)(Up to 3 months, from date of inclusion in CMAM program until the date of recovery or 12th week after inclusion in CMAM program or date of death from any cause, whichever came first)
- Child weight (cohort 3)(Up to 4 months, at three months after discharge from CMAM treatment)
- Wasting screening coverage (cohort 3)(Up to 4 months, at three months after discharge from CMAM treatment)
- Prevalence of minimum dietary diversity of infant and young children (cohort 3)(Up to 4 months, at three months after discharge from CMAM treatment)
- Prevalence of infant and young child minimum meal frequency (cohort 3)(Up to 4 months, at three months after discharge from CMAM treatment)
- Prevalence of continuous breastfeeding (cohort 1)(Up to 4 months, at three months after discharge from CMAM treatment)