Clinical trial NCT04867694: Integrated Research on Acute Malnutrition in Chad
Official title: Impact Evaluation of a Package of Integrated and Multisectoral Services (PASIM) to Reduce Child Wasting in Chad
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Malnutrition in Childhood
Wasting
Lead sponsor: International Food Policy Research Institute
Sponsor class: OTHER
Collaborators: name: UNICEF
name: Association Sahélienne de Recherches Appliquées pour le Développement Durable
name: ONG Moustagbal
First posted: 2021-04-30
Enrollment: 2089
Sex: ALL
Minimum age (years): 6
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-blinded cluster randomized controlled trial
Primary purpose: OTHER

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.

Eligibility criteria: 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

The exclusion criteria are :

* Congenital malformations that make anthropometric measurements impossible.
* Mother intends to leave the study area by December 2021.

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.

Primary outcomes:
measure: Longitudinal prevalence of wasting among children enrolled at 6 months of age followed monthly until the end of the study (Cohort 1).
timeFrame: 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
measure: 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).
timeFrame: 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
measure: 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).
timeFrame: 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
Secondary outcomes:
measure: Longitudinal prevalence of MAM (cohorts 1 & 3)
timeFrame: 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
measure: Longitudinal prevalence of SAM (cohorts 1 & 3)
timeFrame: 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
measure: Incidence of wasting, MAM and SAM (cohort 1)
timeFrame: 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
measure: Incidence of MAM and SAM (cohort 3)
timeFrame: 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
measure: prevalence of anemia (cohorts 1 & 3)
timeFrame: Up to 9 months, from date of enrolment until the date of last documented progression
measure: Mean hemoglobin concentration (cohorts 1 & 3)
timeFrame: Up to 9 months, from date of enrolment until the date of last documented progression
measure: Prevalence of stunting (cohorts 1 & 3)
timeFrame: 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
measure: Height-for-age Z-score (cohorts 1 & 3)
timeFrame: 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
measure: Longitudinal wasting screening coverage (cohorts 1 & 3)
timeFrame: 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
measure: Referral rate of positive screenings (cohorts 1 & 3)
timeFrame: 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
measure: Enrollment of wasting, MAM, and SAM cases (cohorts 1 & 3)
timeFrame: 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
measure: Linear growth rate (cohorts 1 & 3)
timeFrame: 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
measure: Speed of weight growth (cohorts 1 & 3)
timeFrame: 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
measure: Weight gain (cohorts 1 & 3)
timeFrame: 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
measure: MUAC gain (cohorts 1 & 3)
timeFrame: 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
measure: longitudinal prevalence of childhood morbidity, i.e. acute respiratory infections, fever, diarrhea and malaria (cohorts 1 & 3)
timeFrame: 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
measure: Parental knowledge of nutrition, WASH, and health best practices (cohorts 1 & 3)
timeFrame: 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
measure: Longitudinal prevalence of minimum dietary diversity of infant and young children (cohorts 1 & 3)
timeFrame: 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
measure: Longitudinal prevalence of Introduction of (semi) solid and soft complementary foods (cohorts 1 & 3)
timeFrame: 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
measure: Longitudinal prevalence of minimum meal frequency (cohorts 1 & 3)
timeFrame: 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
measure: Practices related to water, hygiene and sanitation (cohorts 1 & 3)
timeFrame: 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
measure: Vaccination coverage (cohorts 1 & 3)
timeFrame: 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
measure: weight-for-height in z-score at enrollment in CMAM (cohort 2)
timeFrame: at the date of inclusion in CMAM program
measure: MUAC at enrollment in CMAM (cohort 2)
timeFrame: at the date of inclusion in CMAM program
measure: Duration of CMAM treatment (cohort 2)
timeFrame: 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
measure: Treatment adherence (cohort 2)
timeFrame: 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
measure: Treatment outcomes (drop-out, death, transfer, non-response rates) (cohort 2)
timeFrame: 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
measure: longitudinal prevalence of childhood morbidity (cohort 2)
timeFrame: 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
Other outcomes:
Locations:
city: Mongo
country: Chad
facility: Mongo Health District
state: Guera
Study officials:
affiliation: IFPRI
name: Lieven Huybregts, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: IFPRI
name: Elodie Becquey, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: IFPRI
name: Jef Leroy, PhD
role: PRINCIPAL_INVESTIGATOR
References: