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Completed

NCT Number: NCT04867694

Integrated Research on Acute Malnutrition 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.

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Key information

Conditions

Acute Malnutrition in Childhood Body Weight Body Weight Changes Cachexia Pathological Conditions, Signs and Symptoms Signs and Symptoms Thinness Wasting Weight Loss

Age range

6 month–23 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mongo Health District

Mongo, Guéra Region, Chad

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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).

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.

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.

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

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).

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

Secondary outcomes

  1. 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

    defined as the number of MAM diagnoses divided by the total number of monthly visits made

  2. 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

    Defined as the number of SAM diagnoses divided by the total number of monthly visits made

  3. 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

    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).

  4. 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

    defined as the number of new cases of MAM and SAM recorded during monthly visits.

  5. prevalence of anemia (cohorts 1 & 3)

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

    Proportion of children with a hemoglobin level below 11g/dl

  6. Mean hemoglobin concentration (cohorts 1 & 3)

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

    Mean hemoglobin concentration measures by hemocue reader

  7. 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

    proportion of children with HAZ <-2 (relative to the 2006 WHO reference)

  8. 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

    Height-for-age Z-score relative to the 2006 WHO reference

  9. 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

    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.

  10. 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

    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.

  11. 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

    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.

  12. 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

    change in height-for-age index per month

  13. 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

    change in weight-for-height index per month

  14. 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

    weight change per month

  15. 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

    change in MUAC per month

  16. 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

    the number of diagnoses of daily signs of these morbidities divided by the total number of days reported (1-3 per monthly visit made).

  17. 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

    expressed as cumulative total and domain scores

  18. 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

    the proportion of children who consumed at least 5 of the 8 food groups (including breast milk) the day before the survey.

  19. 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

    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.

  20. 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

    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.

  21. 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

    Standard USAID indicators related to drinking water source, treatment, storage; hand washing; and sanitation

  22. 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

    Proportion of children with complete vaccination for their age

  23. weight-for-height in z-score at enrollment in CMAM (cohort 2)

    Time frame: at the date of inclusion in CMAM program

    weight-for-height in z-score (relative to the 2006 WHO reference)

  24. MUAC at enrollment in CMAM (cohort 2)

    Time frame: at the date of inclusion in CMAM program

    Mid-upper arm circumference (mm)

  25. 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

    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

  26. 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

    defined as the proportion of cases enrolled for treatment who received timely treatment from dedicated services until recovery

  27. 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

    Among proportion of cases enrolled for treatment

  28. 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

    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.

Sponsors and collaborators

Lead sponsor

International Food Policy Research Institute

Other

Collaborators

  • Association Sahélienne de Recherches Appliquées pour le Développement Durable
  • ONG Moustagbal
  • UNICEF

Registry information

Official study title

Impact Evaluation of a Package of Integrated and Multisectoral Services (PASIM) to Reduce Child Wasting in Chad

Acronym: IRAM-CHAD

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 30, 2021
Registry last updated
Feb 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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