Impact Evaluation of a Package of Integrated and Multisectoral Services (PASIM) to Reduce Child Wasting in Chad
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,089
- 试验地点
- 1
- 主要终点
- Longitudinal prevalence of wasting among children enrolled at 6 months of age followed monthly until the end of the study (Cohort 1).
研究概览
简要总结
The IRAM Chad impact evaluation will be based on a cluster randomized controlled trial to study the impact of the integrated and multisectoral services package (PASIM), aimed at reducing the incidence and prevalence of wasting through integrated interventions, including, among other things, strengthening the activity of community care groups, food supplementation, water treatment, and screening for wasting conducted by families.
详细描述
The general objective of the integrated and multisectoral services package (PASIM) is to reduce the incidence and prevalence of wasting through integrated interventions, including, among other things, strengthening the activity of community care groups. The members of the care groups conduct home visits to children aged 6-23 months (or up to 59 months when the children are under treatment for wasting or have been discharged in the previous 6 months) to deliver messages for behavioral change related to complementary feeding, health and hygiene ; deliver nutritional supplement and water purification inputs; improve screening coverage (training and supervision of families to take the Mid-Upper Arm Circumference measurements, referral of malnourished cases); and verify adherence to treatment of malnourished cases, in the health district of Mongo, Guéra province, Chad, Central Africa.
The evaluation of the impact of PASIM will be based on a cluster randomized controlled trial, consisting of 100 villages or clusters of villages. The selected evaluation model will be that of a comparison of control groups (n=50; no implementation of the intervention) and intervention (n=50) through the follow-up of 3 cohorts :
- Longitudinal in-home follow-up of a semi-open cohort of 1,750 children aged 6 months at enrollment (included continuously for 7 months and all followed through to the end of the study, which will last 9 months in total).
- Longitudinal follow-up of all children aged 6-23 months enrolled for wasting treatment, based on health system records.
- Longitudinal follow-up at home for 6 months of a closed cohort of 700 children aged 6-23 months at inclusion, discharged from a treatment for acute malnutrition.
The primary impact results are as follows:
- The longitudinal prevalence of wasting at the end of the study (Cohort 1).
- The recovery rate (Cohort 2).
- The incidence of relapse during the 11 months of the intervention (Cohort 3).
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 (home visits):
- •The criteria for inclusion of children in the main cohort are:
- •6-6.9 months of age
- •Child 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 by December
- •Cohort 2 (health registers-based):
- •The criteria for inclusion in the treatment cohort are :
- •The child is included in a national treatment program.
- •The child is between 6 and 23 months of age at inclusion
- •Child lives in one of the 100 villages in the study area
- •Cohort 3 (home visits):
- •The inclusion criteria for the relapse study are:
- •Child has been successfully treated for wasting (moderate or severe) and has been discharged from the national treatment program within the last 30 days.
- •The child is between 6 and 23 months of age at inclusion.
- •The child is singleton.
- •The mother must live in the study area from the time of inclusion.
- •The consent of the mother or guardian
- •The exclusion criteria are :
- •Congenital malformations that make anthropometric measurements impossible.
- •Mother intends to leave the study area by December 2021.
研究组 & 干预措施
Intervention
The PASIM is delivered by the care groups. Each beneficiary is visited at home at least once a month (up to once a week if possible).
The package of activities includes :
Behavior change communication (all children in care groups)
Monthly delivery of a nutritional supplement: limited to [6-11] months old children diagnosed as non-wasted (green MUAC) or for [6-59] months old for 6 months after discharge from the national CMAM program.
Monthly delivery of a water purification input: limited to households with [6-11] months old children or with [6-59] months old children under CMAM treatment and for 6 months after discharge.
Delivery of micronutrient powders to [12-23] months old children.
Screening and referral for [6-59] months old children, formative supervision of MUAC measurement in families.
干预措施: Water purification input (Other)
Control
The control group receiving the standards of care and the usual activities of the partners without additional support from the IRAM project for the implementation of the PASIM. This includes the usual Community Management of Acute Malnutrition (CMAM) program. This group will also continue to benefit from the BCC and screening services already existing in their areas.
Intervention
The PASIM is delivered by the care groups. Each beneficiary is visited at home at least once a month (up to once a week if possible).
The package of activities includes :
Behavior change communication (all children in care groups)
Monthly delivery of a nutritional supplement: limited to [6-11] months old children diagnosed as non-wasted (green MUAC) or for [6-59] months old for 6 months after discharge from the national CMAM program.
Monthly delivery of a water purification input: limited to households with [6-11] months old children or with [6-59] months old children under CMAM treatment and for 6 months after discharge.
Delivery of micronutrient powders to [12-23] months old children.
Screening and referral for [6-59] months old children, formative supervision of MUAC measurement in families.
干预措施: BCC (Behavioral)
Intervention
The PASIM is delivered by the care groups. Each beneficiary is visited at home at least once a month (up to once a week if possible).
The package of activities includes :
Behavior change communication (all children in care groups)
Monthly delivery of a nutritional supplement: limited to [6-11] months old children diagnosed as non-wasted (green MUAC) or for [6-59] months old for 6 months after discharge from the national CMAM program.
Monthly delivery of a water purification input: limited to households with [6-11] months old children or with [6-59] months old children under CMAM treatment and for 6 months after discharge.
Delivery of micronutrient powders to [12-23] months old children.
Screening and referral for [6-59] months old children, formative supervision of MUAC measurement in families.
干预措施: Preventive supplement (Dietary Supplement)
Intervention
The PASIM is delivered by the care groups. Each beneficiary is visited at home at least once a month (up to once a week if possible).
The package of activities includes :
Behavior change communication (all children in care groups)
Monthly delivery of a nutritional supplement: limited to [6-11] months old children diagnosed as non-wasted (green MUAC) or for [6-59] months old for 6 months after discharge from the national CMAM program.
Monthly delivery of a water purification input: limited to households with [6-11] months old children or with [6-59] months old children under CMAM treatment and for 6 months after discharge.
Delivery of micronutrient powders to [12-23] months old children.
Screening and referral for [6-59] months old children, formative supervision of MUAC measurement in families.
干预措施: MNP (Dietary Supplement)
Intervention
The PASIM is delivered by the care groups. Each beneficiary is visited at home at least once a month (up to once a week if possible).
The package of activities includes :
Behavior change communication (all children in care groups)
Monthly delivery of a nutritional supplement: limited to [6-11] months old children diagnosed as non-wasted (green MUAC) or for [6-59] months old for 6 months after discharge from the national CMAM program.
Monthly delivery of a water purification input: limited to households with [6-11] months old children or with [6-59] months old children under CMAM treatment and for 6 months after discharge.
Delivery of micronutrient powders to [12-23] months old children.
Screening and referral for [6-59] months old children, formative supervision of MUAC measurement in families.
干预措施: Family MUAC (Behavioral)
Intervention
The PASIM is delivered by the care groups. Each beneficiary is visited at home at least once a month (up to once a week if possible).
The package of activities includes :
Behavior change communication (all children in care groups)
Monthly delivery of a nutritional supplement: limited to [6-11] months old children diagnosed as non-wasted (green MUAC) or for [6-59] months old for 6 months after discharge from the national CMAM program.
Monthly delivery of a water purification input: limited to households with [6-11] months old children or with [6-59] months old children under CMAM treatment and for 6 months after discharge.
Delivery of micronutrient powders to [12-23] months old children.
Screening and referral for [6-59] months old children, formative supervision of MUAC measurement in families.
干预措施: Screening by care group (Behavioral)
Intervention
The PASIM is delivered by the care groups. Each beneficiary is visited at home at least once a month (up to once a week if possible).
The package of activities includes :
Behavior change communication (all children in care groups)
Monthly delivery of a nutritional supplement: limited to [6-11] months old children diagnosed as non-wasted (green MUAC) or for [6-59] months old for 6 months after discharge from the national CMAM program.
Monthly delivery of a water purification input: limited to households with [6-11] months old children or with [6-59] months old children under CMAM treatment and for 6 months after discharge.
Delivery of micronutrient powders to [12-23] months old children.
Screening and referral for [6-59] months old children, formative supervision of MUAC measurement in families.
干预措施: CMAM compliance (Behavioral)
结局指标
主要结局
Longitudinal prevalence of wasting among children enrolled at 6 months of age followed monthly until the end of the study (Cohort 1).
时间窗: Up to 9 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 wasting is observed divided by the total number of monthly visits made (by 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 of discharges considered cured 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 program) divided by the total number of exits recorded.
Incidence of wasting in children enrolled at [6-23] months of age at discharge from a CMAM program cured, and followed for 6 months (Cohort 3).
时间窗: Up to 6 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 as the number of new cases of wasting recorded during monthly visits.
次要结局
- Longitudinal wasting screening coverage (cohorts 1 & 3)(Up to 9 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 9 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
- Incidence of MAM and SAM (cohort 3)(Up to 9 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 MAM (cohorts 1 & 3)(Up to 9 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
- MUAC gain (cohorts 1 & 3)(Up to 9 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
- Speed of weight growth (cohorts 1 & 3)(Up to 9 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 childhood morbidity, i.e. acute respiratory infections, fever, diarrhea and malaria (cohorts 1 & 3)(Up to 9 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
- MUAC at enrollment in CMAM (cohort 2)(at the date of inclusion in CMAM program)
- 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)
- Longitudinal prevalence of SAM (cohorts 1 & 3)(Up to 9 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 (cohorts 1 & 3)(Up to 9 months, from date of enrolment until the date of last documented progression)
- Prevalence of stunting (cohorts 1 & 3)(Up to 9 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 (cohorts 1 & 3)(Up to 9 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
- Vaccination coverage (cohorts 1 & 3)(Up to 9 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
- Mean hemoglobin concentration (cohorts 1 & 3)(Up to 9 months, from date of enrolment until the date of last documented progression)
- Height-for-age Z-score (cohorts 1 & 3)(Up to 9 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 (cohorts 1 & 3)(Up to 9 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
- Enrollment of wasting, MAM, and SAM cases (cohorts 1 & 3)(Up to 9 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 (cohorts 1 & 3)(Up to 9 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
- Weight gain (cohorts 1 & 3)(Up to 9 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 minimum dietary diversity of infant and young children (cohorts 1 & 3)(Up to 9 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 minimum meal frequency (cohorts 1 & 3)(Up to 9 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
- Practices related to water, hygiene and sanitation (cohorts 1 & 3)(Up to 9 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
- weight-for-height in z-score at enrollment in CMAM (cohort 2)(at the date of inclusion in CMAM program)
- 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 first)
- Longitudinal prevalence of Introduction of (semi) solid and soft complementary foods (cohorts 1 & 3)(Up to 9 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first)
- 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)
- 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)
研究者
Elodie Becquey
Senior Research Fellow
International Food Policy Research Institute