Integrated Research on Acute Malnutrition in Chad

Not Applicable

Completed

• Conditions: Acute Malnutrition in Childhood; Wasting
• Interventions: Behavioral: BCC; Dietary Supplement: Preventive supplement; Dietary Supplement: MNP; Other: Water purification input; Behavioral: Family MUAC; Behavioral: Screening by care group; Behavioral: CMAM compliance

• Registration Number: NCT04867694
• Lead Sponsor: International Food Policy Research Institute

Brief Summary

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.

Detailed Description

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 :

1. 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).

2. Longitudinal follow-up of all children aged 6-23 months enrolled for wasting treatment, based on health system records.

3. 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).

Secondary impact results include, but are not limited to :

* The incidence of wasting during the 11 months of the intervention (Cohort 1) ;

* The screening coverage (cohorts 1 and 3);

* The proportion of wasting cases enrolled in a treatment program (cohorts 1 and 3);

* The adherence to treatment (cohort 2) during the 11 months of the intervention.

Study Timeline

• Study First Submitted: 2021-04-12
• Study First Submitted QC: 2021-04-28
• Study First Posted: 2021-04-30
• Study Start: 2021-05-03
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-09
• Last Update Posted: 2023-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2089

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	MNP	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.
Intervention	BCC	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.
Intervention	Preventive supplement	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.
Intervention	Water purification input	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.
Intervention	Screening by care group	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.
Intervention	Family MUAC	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.
Intervention	CMAM compliance	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.

Primary Outcome Measures

Name	Time	Method
Longitudinal prevalence of wasting among children enrolled at 6 months of age followed monthly until the end of the study (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	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).	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).	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.

Secondary Outcome Measures

Name	Time	Method
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	defined as the proportion of children screened (using MUAC, weight-for-height or bilateral edema) in the month prior to the monthly visit. Two sub-outcomes will also be concerned: * Screening coverage by care groups.; * Coverage of the family MUAC component, which is the screening performed by a family member in the past month.
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	defined as the number of new cases of wasting, MAM and SAM recorded during monthly visits among children enrolled at 6 months of age followed monthly until the end of the study (Cohort 1).
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	defined as the number of new cases of MAM and SAM recorded during monthly visits.
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	defined as the number of MAM diagnoses divided by the total number of monthly visits made
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	change in MUAC per month
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	change in weight-for-height index per month
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	the number of diagnoses of daily signs of these morbidities divided by the total number of days reported (1-3 per monthly visit made).
MUAC at enrollment in CMAM (cohort 2)	at the date of inclusion in CMAM program	Mid-upper arm circumference (mm)
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	defined as the proportion of cases enrolled for treatment who received timely treatment from dedicated services until recovery
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	Defined as the number of SAM diagnoses divided by the total number of monthly visits made
prevalence of anemia (cohorts 1 & 3)	Up to 9 months, from date of enrolment until the date of last documented progression	Proportion of children with a hemoglobin level below 11g/dl
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	proportion of children with HAZ \<-2 (relative to the 2006 WHO reference)
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	expressed as cumulative total and domain scores
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	Proportion of children with complete vaccination for their age
Mean hemoglobin concentration (cohorts 1 & 3)	Up to 9 months, from date of enrolment until the date of last documented progression	Mean hemoglobin concentration measures by hemocue reader
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	Height-for-age Z-score relative to the 2006 WHO reference
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	defined as the proportion of children who tested positive during the month (according to the mother) and not under CMAM treatment who were referred to the health center or FARNE site.
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	proportion of cases who tested positive in the month prior to the monthly visit and not under CMAM treatment who were enrolled in a CMAM treatment program.
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	change in height-for-age index per month
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	weight change per month
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	the proportion of children who consumed at least 5 of the 8 food groups (including breast milk) the day before the survey.
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	the proportion of children who consumed the minimum recommended number of meals for their age on the day before the survey Minimum dietary diversity in children, defined as the proportion of children who consumed at least 5 of the 8 food groups (including breast milk) the day before the survey.; Minimum meal frequency for children, defined as the proportion of children who had eaten the day before the survey: 2 meals for breastfed children 6-8 months, 3 meals for breastfed children 9-23 months, or 4 meals for non-breastfed children 6-23 months.; Minimum acceptable diet, defined as the proportion of children with both minimal dietary diversity and minimal meal frequency on the day before the survey.; Consumption of iron-rich or iron-fortified foods in children.
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	Standard USAID indicators related to drinking water source, treatment, storage; hand washing; and sanitation
weight-for-height in z-score at enrollment in CMAM (cohort 2)	at the date of inclusion in CMAM program	weight-for-height in z-score (relative to the 2006 WHO reference)
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	Among proportion of cases enrolled for treatment
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	the proportion of children 6-8 months of age who consumed (semi) solid and soft complementary foods the day before the survey Minimum dietary diversity in children, defined as the proportion of children who consumed at least 5 of the 8 food groups (including breast milk) the day before the survey.; Minimum meal frequency for children, defined as the proportion of children who had eaten the day before the survey: 2 meals for breastfed children 6-8 months, 3 meals for breastfed children 9-23 months, or 4 meals for non-breastfed children 6-23 months.; Minimum acceptable diet, defined as the proportion of children with both minimal dietary diversity and minimal meal frequency on the day before the survey.; Consumption of iron-rich or iron-fortified foods in children.
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	defined as the number of days spent on treatment (enrollment and discharge) in children 6-23 months of age at enrollment, according to health registers
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	defined by the number of days for which signs of these morbidities were reported divided by the total number of days observed/reported in the recall periods.

Trial Locations

Locations (1)

Mongo Health District; 🇹🇩 Mongo, Guera, Chad