Integrated Research on Acute Malnutrition in Chad (IRAM-CHAD)

International Food Policy Research Institute

Status: Completed

Conditions: Acute Malnutrition in Childhood; Wasting

Treatments: Dietary Supplement: MNP; Behavioral: Screening by care group; Behavioral: Family MUAC; Behavioral: CMAM compliance; Other: Water purification input; Dietary Supplement: Preventive supplement; Behavioral: BCC

Study type: Interventional

Funder types: Other

Identifiers

NCT04867694

IRAM-TCHAD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,089 patients

Sex: All

Ages: 6 to 23 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,089 participants in 2 patient groups

Control

No Intervention group

Description:

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

Experimental group

Description:

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.

Treatment:

Behavioral: CMAM compliance

Dietary Supplement: MNP

Behavioral: BCC

Behavioral: Screening by care group

Other: Water purification input

Behavioral: Family MUAC

Dietary Supplement: Preventive supplement