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

Primary Purpose

Acute Malnutrition in Childhood, Wasting

Status
Completed
Phase
Not Applicable
Locations
Chad
Study Type
Interventional
Intervention
BCC
Preventive supplement
MNP
Water purification input
Family MUAC
Screening by care group
CMAM compliance
Sponsored by
International Food Policy Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Acute Malnutrition in Childhood

Eligibility Criteria

6 Months - 23 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mongo Health District

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm 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.

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.

Outcomes

Primary Outcome Measures

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).
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.
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.

Secondary Outcome Measures

Longitudinal prevalence of MAM (cohorts 1 & 3)
defined as the number of MAM diagnoses divided by the total number of monthly visits made
Longitudinal prevalence of SAM (cohorts 1 & 3)
Defined as the number of SAM diagnoses divided by the total number of monthly visits made
Incidence of wasting, MAM and SAM (cohort 1)
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)
defined as the number of new cases of MAM and SAM recorded during monthly visits.
prevalence of anemia (cohorts 1 & 3)
Proportion of children with a hemoglobin level below 11g/dl
Mean hemoglobin concentration (cohorts 1 & 3)
Mean hemoglobin concentration measures by hemocue reader
Prevalence of stunting (cohorts 1 & 3)
proportion of children with HAZ <-2 (relative to the 2006 WHO reference)
Height-for-age Z-score (cohorts 1 & 3)
Height-for-age Z-score relative to the 2006 WHO reference
Longitudinal wasting screening coverage (cohorts 1 & 3)
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.
Referral rate of positive screenings (cohorts 1 & 3)
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)
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)
change in height-for-age index per month
Speed of weight growth (cohorts 1 & 3)
change in weight-for-height index per month
Weight gain (cohorts 1 & 3)
weight change per month
MUAC gain (cohorts 1 & 3)
change in MUAC per month
longitudinal prevalence of childhood morbidity, i.e. acute respiratory infections, fever, diarrhea and malaria (cohorts 1 & 3)
the number of diagnoses of daily signs of these morbidities divided by the total number of days reported (1-3 per monthly visit made).
Parental knowledge of nutrition, WASH, and health best practices (cohorts 1 & 3)
expressed as cumulative total and domain scores
Longitudinal prevalence of minimum dietary diversity of infant and young children (cohorts 1 & 3)
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 Introduction of (semi) solid and soft complementary foods (cohorts 1 & 3)
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.
Longitudinal prevalence of minimum meal frequency (cohorts 1 & 3)
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)
Standard USAID indicators related to drinking water source, treatment, storage; hand washing; and sanitation
Vaccination coverage (cohorts 1 & 3)
Proportion of children with complete vaccination for their age
weight-for-height in z-score at enrollment in CMAM (cohort 2)
weight-for-height in z-score (relative to the 2006 WHO reference)
MUAC at enrollment in CMAM (cohort 2)
Mid-upper arm circumference (mm)
Duration of CMAM treatment (cohort 2)
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
Treatment adherence (cohort 2)
defined as the proportion of cases enrolled for treatment who received timely treatment from dedicated services until recovery
Treatment outcomes (drop-out, death, transfer, non-response rates) (cohort 2)
Among proportion of cases enrolled for treatment
longitudinal prevalence of childhood morbidity (cohort 2)
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.

Full Information

First Posted
April 12, 2021
Last Updated
February 9, 2023
Sponsor
International Food Policy Research Institute
Collaborators
UNICEF, Association Sahélienne de Recherches Appliquées pour le Développement Durable, ONG Moustagbal
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1. Study Identification

Unique Protocol Identification Number
NCT04867694
Brief Title
Integrated Research on Acute Malnutrition in Chad
Acronym
IRAM-CHAD
Official Title
Impact Evaluation of a Package of Integrated and Multisectoral Services (PASIM) to Reduce Child Wasting in Chad
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 3, 2021 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
International Food Policy Research Institute
Collaborators
UNICEF, Association Sahélienne de Recherches Appliquées pour le Développement Durable, ONG Moustagbal

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 : 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Malnutrition in Childhood, Wasting

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Non-blinded cluster randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2089 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm 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.
Arm Title
Intervention
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
BCC
Intervention Description
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 Type
Dietary Supplement
Intervention Name(s)
Preventive supplement
Intervention Description
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 Type
Dietary Supplement
Intervention Name(s)
MNP
Intervention Description
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 Type
Other
Intervention Name(s)
Water purification input
Intervention Description
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 Type
Behavioral
Intervention Name(s)
Family MUAC
Intervention Description
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 Type
Behavioral
Intervention Name(s)
Screening by care group
Intervention Description
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 Type
Behavioral
Intervention Name(s)
CMAM compliance
Intervention Description
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).
Primary Outcome Measure Information:
Title
Longitudinal prevalence of wasting among children enrolled at 6 months of age followed monthly until the end of the study (Cohort 1).
Description
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).
Time Frame
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
Title
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).
Description
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.
Time Frame
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
Title
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).
Description
This indicator is defined as the number of new cases of wasting recorded during monthly visits.
Time Frame
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 Outcome Measure Information:
Title
Longitudinal prevalence of MAM (cohorts 1 & 3)
Description
defined as the number of MAM diagnoses divided by the total number of monthly visits made
Time Frame
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
Title
Longitudinal prevalence of SAM (cohorts 1 & 3)
Description
Defined as the number of SAM diagnoses divided by the total number of monthly visits made
Time Frame
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
Title
Incidence of wasting, MAM and SAM (cohort 1)
Description
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).
Time Frame
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
Title
Incidence of MAM and SAM (cohort 3)
Description
defined as the number of new cases of MAM and SAM recorded during monthly visits.
Time Frame
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
Title
prevalence of anemia (cohorts 1 & 3)
Description
Proportion of children with a hemoglobin level below 11g/dl
Time Frame
Up to 9 months, from date of enrolment until the date of last documented progression
Title
Mean hemoglobin concentration (cohorts 1 & 3)
Description
Mean hemoglobin concentration measures by hemocue reader
Time Frame
Up to 9 months, from date of enrolment until the date of last documented progression
Title
Prevalence of stunting (cohorts 1 & 3)
Description
proportion of children with HAZ <-2 (relative to the 2006 WHO reference)
Time Frame
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
Title
Height-for-age Z-score (cohorts 1 & 3)
Description
Height-for-age Z-score relative to the 2006 WHO reference
Time Frame
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
Title
Longitudinal wasting screening coverage (cohorts 1 & 3)
Description
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.
Time Frame
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
Title
Referral rate of positive screenings (cohorts 1 & 3)
Description
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.
Time Frame
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
Title
Enrollment of wasting, MAM, and SAM cases (cohorts 1 & 3)
Description
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.
Time Frame
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
Title
Linear growth rate (cohorts 1 & 3)
Description
change in height-for-age index per month
Time Frame
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
Title
Speed of weight growth (cohorts 1 & 3)
Description
change in weight-for-height index per month
Time Frame
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
Title
Weight gain (cohorts 1 & 3)
Description
weight change per month
Time Frame
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
Title
MUAC gain (cohorts 1 & 3)
Description
change in MUAC per month
Time Frame
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
Title
longitudinal prevalence of childhood morbidity, i.e. acute respiratory infections, fever, diarrhea and malaria (cohorts 1 & 3)
Description
the number of diagnoses of daily signs of these morbidities divided by the total number of days reported (1-3 per monthly visit made).
Time Frame
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
Title
Parental knowledge of nutrition, WASH, and health best practices (cohorts 1 & 3)
Description
expressed as cumulative total and domain scores
Time Frame
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
Title
Longitudinal prevalence of minimum dietary diversity of infant and young children (cohorts 1 & 3)
Description
the proportion of children who consumed at least 5 of the 8 food groups (including breast milk) the day before the survey.
Time Frame
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
Title
Longitudinal prevalence of Introduction of (semi) solid and soft complementary foods (cohorts 1 & 3)
Description
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.
Time Frame
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
Title
Longitudinal prevalence of minimum meal frequency (cohorts 1 & 3)
Description
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.
Time Frame
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
Title
Practices related to water, hygiene and sanitation (cohorts 1 & 3)
Description
Standard USAID indicators related to drinking water source, treatment, storage; hand washing; and sanitation
Time Frame
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
Title
Vaccination coverage (cohorts 1 & 3)
Description
Proportion of children with complete vaccination for their age
Time Frame
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
Title
weight-for-height in z-score at enrollment in CMAM (cohort 2)
Description
weight-for-height in z-score (relative to the 2006 WHO reference)
Time Frame
at the date of inclusion in CMAM program
Title
MUAC at enrollment in CMAM (cohort 2)
Description
Mid-upper arm circumference (mm)
Time Frame
at the date of inclusion in CMAM program
Title
Duration of CMAM treatment (cohort 2)
Description
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
Time Frame
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
Title
Treatment adherence (cohort 2)
Description
defined as the proportion of cases enrolled for treatment who received timely treatment from dedicated services until recovery
Time Frame
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
Title
Treatment outcomes (drop-out, death, transfer, non-response rates) (cohort 2)
Description
Among proportion of cases enrolled for treatment
Time Frame
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
Title
longitudinal prevalence of childhood morbidity (cohort 2)
Description
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.
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
23 Months
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lieven Huybregts, PhD
Organizational Affiliation
IFPRI
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elodie Becquey, PhD
Organizational Affiliation
IFPRI
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jef Leroy, PhD
Organizational Affiliation
IFPRI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mongo Health District
City
Mongo
State/Province
Guera
Country
Chad

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
In accordance with IFPRI's policy on research data management and open access, 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.
IPD Sharing 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.

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Integrated Research on Acute Malnutrition in Chad

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