Acute Malnutrition in ChildhoodIRAM-CHADNCT04867694
Integrated Research on Acute Malnutrition in Chad
A study testing BCC, Preventive supplement and MNP in people with Acute Malnutrition in Childhood and Wasting, run by International Food Policy Research Institute at 1 site in Chad.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 23 months
- Conditions the study is for
- Acute Malnutrition in Childhood, Wasting
- What is being tested?
- BCC, Preventive supplement and MNP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,089 participants
- Where
- 1 siteChad
- Study dates
- 3 May 2021to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 23 months
- All sexes
- No healthy volunteers
- Child
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 locations and contacts
1 site in 1 country.
Chad1 site
Mongo Health District
Mongo, Guéra Region
About this study
Official title: Impact Evaluation of a Package of Integrated and Multisectoral Services (PASIM) to Reduce Child Wasting in Chad
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.
Read the 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.
- Conditions
- Acute Malnutrition in Childhood, Wasting
- Being tested
- BCC, Preventive supplement, MNP, Water purification input, Family MUAC
- Medical subject headings
- Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCCBehavioural
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.
Preventive supplementDietary 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.
MNPDietary 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).
Water purification inputOther
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.
Family MUACBehavioural
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.
Screening by care groupBehavioural
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
CMAM complianceBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: BCC; Dietary Supplement: Preventive supplement; Dietary Supplement: MNP; Other: Water purification input; Behavioral: Family MUAC; Behavioral: Screening by care group; Behavioral: CMAM compliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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)
defined as the number of MAM diagnoses divided by the total number of monthly visits made
Measured: 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)
Defined as the number of SAM diagnoses divided by the total number of monthly visits made
Measured: 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)
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).
Measured: 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)
defined as the number of new cases of MAM and SAM recorded during monthly visits.
Measured: 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)
Proportion of children with a hemoglobin level below 11g/dl
Measured: Up to 9 months, from date of enrolment until the date of last documented progression
Mean hemoglobin concentration (cohorts 1 & 3)
Mean hemoglobin concentration measures by hemocue reader
Measured: Up to 9 months, from date of enrolment until the date of last documented progression
Prevalence of stunting (cohorts 1 & 3)
proportion of children with HAZ <-2 (relative to the 2006 WHO reference)
Measured: 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 (cohorts 1 & 3)
Height-for-age Z-score relative to the 2006 WHO reference
Measured: 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 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Linear growth rate (cohorts 1 & 3)
change in height-for-age index per month
Measured: 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
Speed of weight growth (cohorts 1 & 3)
change in weight-for-height index per month
Measured: 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 gain (cohorts 1 & 3)
weight change per month
Measured: 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
MUAC gain (cohorts 1 & 3)
change in MUAC per month
Measured: 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 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).
Measured: 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
Parental knowledge of nutrition, WASH, and health best practices (cohorts 1 & 3)
expressed as cumulative total and domain scores
Measured: 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 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.
Measured: 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 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.
Measured: 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 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.
Measured: 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
Practices related to water, hygiene and sanitation (cohorts 1 & 3)
Standard USAID indicators related to drinking water source, treatment, storage; hand washing; and sanitation
Measured: 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
Vaccination coverage (cohorts 1 & 3)
Proportion of children with complete vaccination for their age
Measured: 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-for-height in z-score at enrollment in CMAM (cohort 2)
weight-for-height in z-score (relative to the 2006 WHO reference)
Measured: at the date of inclusion in CMAM program
MUAC at enrollment in CMAM (cohort 2)
Mid-upper arm circumference (mm)
Measured: at the date of inclusion in CMAM program
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
Measured: 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
Treatment adherence (cohort 2)
defined as the proportion of cases enrolled for treatment who received timely treatment from dedicated services until recovery
Measured: 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
Treatment outcomes (drop-out, death, transfer, non-response rates) (cohort 2)
Among proportion of cases enrolled for treatment
Measured: 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
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start3 May 2021
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Malnutrition in ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Non-blinded cluster randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 2,089 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Food Policy Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- UNICEF, Association Sahélienne de Recherches Appliquées pour le Développement Durable, ONG Moustagbal
- Responsible party
- Principal investigator, Elodie Becquey, International Food Policy Research Institute
- Investigators
- Lieven Huybregts, PhD, Principal investigator, IFPRIElodie Becquey, PhD, Principal investigator, IFPRIJef Leroy, PhD, Principal investigator, IFPRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04867694
- Sponsor's protocol ID
- IRAM-TCHAD
- Acronym
- IRAM-CHAD
- Status last verified
- Feb 2023
- First submitted
- 12 Apr 2021
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Evaluation of a Package of Integrated and Multisectoral Services (PASIM) to Reduce Child Wasting in Chad
- ClinicalTrials.gov ID
- NCT04867694
- Acronym / sponsor ID
- IRAM-CHAD / IRAM-TCHAD
- Conditions
- Acute Malnutrition in Childhood, Wasting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,089 participants (actual)
- Lead sponsor
- International Food Policy Research InstituteUniversity, hospital or other
- Collaborators
- UNICEF, Association Sahélienne de Recherches Appliquées pour le Développement Durable, ONG Moustagbal
- Study start
- 3 May 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 30 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-blinded cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: BCC, Dietary Supplement: Preventive supplement, Dietary Supplement: MNP, Other: Water purification input, Behavioral: Family MUAC, Behavioral: Screening by care group, Behavioral: CMAM complianceThe 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. |
Who may qualify
- Ages
- 6 to 23 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCCBehavior 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. | Behavioural | Intervention |
| Preventive supplementMonthly 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. | Dietary supplement | Intervention |
| MNPDelivery of micronutrient powders to [12-23] months old children (30 sachets per month for 2 months, every 6 months, according to international recommendations). | Dietary supplement | Intervention |
| Water purification inputMonthly 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. | Other | Intervention |
| Family MUACOne-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. | Behavioural | Intervention |
| Screening by care groupMonthly 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 | Behavioural | Intervention |
| CMAM complianceWeekly 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). | Behavioural | Intervention |
Primary outcome
Longitudinal prevalence of wasting 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
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).
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
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).
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
This indicator is defined as the number of new cases of wasting recorded during monthly visits.
28 secondary outcomes
Longitudinal prevalence of MAM (cohorts 1 & 3)
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
Longitudinal prevalence of SAM (cohorts 1 & 3)
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
Incidence of wasting, MAM and SAM (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
Incidence of MAM and SAM (cohort 3)
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
prevalence of anemia (cohorts 1 & 3)
Time frame: Up to 9 months, from date of enrolment until the date of last documented progression
Mean hemoglobin concentration (cohorts 1 & 3)
Time frame: Up to 9 months, from date of enrolment until the date of last documented progression
Prevalence of stunting (cohorts 1 & 3)
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
Height-for-age Z-score (cohorts 1 & 3)
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
Longitudinal wasting screening coverage (cohorts 1 & 3)
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
Referral rate of positive screenings (cohorts 1 & 3)
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
Enrollment of wasting, MAM, and SAM cases (cohorts 1 & 3)
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
Linear growth rate (cohorts 1 & 3)
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
Speed of weight growth (cohorts 1 & 3)
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
Weight gain (cohorts 1 & 3)
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
MUAC gain (cohorts 1 & 3)
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
longitudinal prevalence of childhood morbidity, i.e. acute respiratory infections, fever, diarrhea and malaria (cohorts 1 & 3)
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
Parental knowledge of nutrition, WASH, and health best practices (cohorts 1 & 3)
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
Longitudinal prevalence of minimum dietary diversity of infant and young children (cohorts 1 & 3)
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
Longitudinal prevalence of Introduction of (semi) solid and soft complementary foods (cohorts 1 & 3)
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
Longitudinal prevalence of minimum meal frequency (cohorts 1 & 3)
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
Practices related to water, hygiene and sanitation (cohorts 1 & 3)
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
Vaccination coverage (cohorts 1 & 3)
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
weight-for-height in z-score at enrollment in CMAM (cohort 2)
Time frame: at the date of inclusion in CMAM program
MUAC at enrollment in CMAM (cohort 2)
Time frame: at the date of inclusion in CMAM program
Duration of CMAM treatment (cohort 2)
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
Treatment adherence (cohort 2)
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
Treatment outcomes (drop-out, death, transfer, non-response rates) (cohort 2)
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
longitudinal prevalence of childhood morbidity (cohort 2)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lieven Huybregts, PhD principal investigator
IFPRI
Elodie Becquey, PhD principal investigator
IFPRI
Jef Leroy, PhD principal investigator
IFPRI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCC, Preventive supplement and MNP in people with Acute Malnutrition in Childhood and Wasting, run by International Food Policy Research Institute at 1 site in Chad.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chad. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Longitudinal prevalence of wasting 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.