Integrated Research on Acute Malnutrition in Chad

NCT04867694 | Completed

• 1 other identifier: IRAM-TCHAD
• Study Type: interventional
• Target: 2,089
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Malnutrition in Childhood; Wasting

Outcome Measures

Primary Outcomes (3)

• Longitudinal prevalence of wasting among children enrolled at 6 months of age followed monthly until the end of the study (Cohort 1).

  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).

  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

• 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).

  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.

  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

• 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).

  This indicator is defined as the number of new cases of wasting recorded during monthly visits.

  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 (28)

• 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

• 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

• 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

• prevalence of anemia (cohorts 1 & 3)

  Up to 9 months, from date of enrolment until the date of last documented progression

Study Arms (2)

Control

NO INTERVENTION

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

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.

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

Interventions

BCC BEHAVIORAL

Behavior change communication on Nutrition, Health \& Hygiene, including (but not limited to) awareness of dietary diversification from 6 months of age and adequate complementary feeding; and raising awareness of good water and hygiene practices.

Intervention

Preventive supplement DIETARY_SUPPLEMENT

Monthly delivery of a nutritional supplement: enriched flour (CSB++), at a dose of 3 kg/month/beneficiary child. The nutritional supplement is limited to \[6-11\] months old children diagnosed as non-wasted (green MUAC); or children \[12-59\] months old for 6 months after discharge from a CMAM treatment or consolidation program.

Intervention

MNP DIETARY_SUPPLEMENT

Delivery of micronutrient powders to \[12-23\] months old children (30 sachets per month for 2 months, every 6 months, according to international recommendations).

Intervention

Water purification input OTHER

Monthly delivery of a water purification input: bleach or flocculant/decontamination sachets for the potabilization of the water of the whole household. The water treatment input is limited to households with \[6-11\] months old children, or children \[12-59\] months old enrolled in a CMAM treatment program and for 6 months after discharge.

Intervention

Family MUAC BEHAVIORAL

One-time delivery of a mid-upper arm circumference (MUAC) measuring tape and training of families in its use, and actions to be taken based on the results. This will involve distributing Shakir bands to all households with \[6-59\] months old children and training mothers/guardians, or any other family members who express an interest, in screening for wasting using the MUAC criteria, and explaining the procedure to follow if the child tests positive in the family. Formative supervision of MUAC measurement in families. The training will be carried out by the members of the care groups and at each home visit, they will be able to ensure that the MUAC measurement technique is well mastered by the mother (or another member) and correct the technique if necessary.

Intervention

Screening by care group BEHAVIORAL

Monthly screening by the care group volunteers of the children they follow, using the MUAC. Referral to the health center of \[6-59\] months old children screened as malnourished (result of MUAC orange or red), and follow-up on referral to confirm child was enrolled

Intervention

CMAM compliance BEHAVIORAL

Weekly follow-up of \[6-59\] months old children under treatment and for 6 months after discharge from the national treatment and consolidation program : care group volunteers follow children under treatment until they recover and for the whole duration of their consolidation (for children cured of severe emaciation) through weekly home visits. They monitor treatment adherence (i.e., families follow the planned schedule of visits and receive inputs for treatment or consolidation) and treatment compliance (i.e., the malnourished or consolidating child receives the planned dose of therapeutic or supplementary food each day).

Intervention

Eligibility Criteria

• Age: 6 Months - 23 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• Congenital malformations that make anthropometric measurements impossible.
• Mother intends to leave the study area by December 2021.
• Cohort 2 (health registers-based):
• The child is included in a national treatment program.
• Child lives in one of the 100 villages in the study area
• Cohort 3 (home visits):
• 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 singleton.
• The consent of the mother or guardian
• Congenital malformations that make anthropometric measurements impossible.
• Mother intends to leave the study area by December 2021.

Sponsors & Collaborators

• International Food Policy Research Institute: lead
• UNICEF: collaborator
• Association Sahélienne de Recherches Appliquées pour le Développement Durable: collaborator
• ONG Moustagbal: collaborator

Study Sites (1)

Mongo Health District

Mongo, Guéra Region, Chad

Location

MeSH Terms

Conditions

Cachexia

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Study Officials

• Lieven Huybregts, PhD

  IFPRI

  PRINCIPAL INVESTIGATOR

• Elodie Becquey, PhD

  IFPRI

  PRINCIPAL INVESTIGATOR

• Jef Leroy, PhD

  IFPRI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Fellow

Model Details: Non-blinded cluster randomized controlled trial

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 30, 2021
• Study Start: May 3, 2021
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: February 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: at the time of publication of scientific articles presenting results, the fully anonymized databases will become a public good and will be made available to the scientific community, government, and partners.

Locations

CH (1)