Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 4:58 AM
Study NCT ID:
NCT04867694
Status:
COMPLETED
Last Update Posted:
2023-02-13
First Post:
2021-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Integrated Research on Acute Malnutrition in Chad
Sponsor:
International Food Policy Research Institute
Organization:
Study Overview
Official Title:
Impact Evaluation of a Package of Integrated and Multisectoral Services (PASIM) to Reduce Child Wasting in Chad
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IRAM-CHAD
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 :
1. Longitudinal in-home follow-up of a semi-open cohort of 1,750 children aged 6 months at enrollment (included continuously for 7 months and all followed through to the end of the study, which will last 9 months in total).
2. Longitudinal follow-up of all children aged 6-23 months enrolled for wasting treatment, based on health system records.
3. Longitudinal follow-up at home for 6 months of a closed cohort of 700 children aged 6-23 months at inclusion, discharged from a treatment for acute malnutrition.
The primary impact results are as follows:
* The longitudinal prevalence of wasting at the end of the study (Cohort 1).
* The recovery rate (Cohort 2).
* The incidence of relapse during the 11 months of the intervention (Cohort 3).
Secondary impact results include, but are not limited to :
* The incidence of wasting during the 11 months of the intervention (Cohort 1) ;
* The screening coverage (cohorts 1 and 3);
* The proportion of wasting cases enrolled in a treatment program (cohorts 1 and 3);
* The adherence to treatment (cohort 2) during the 11 months of the intervention.
The evaluation of the impact of PASIM will be based on a cluster randomized controlled trial, consisting of 100 villages or clusters of villages. The selected evaluation model will be that of a comparison of control groups (n=50; no implementation of the intervention) and intervention (n=50) through the follow-up of 3 cohorts :
1. Longitudinal in-home follow-up of a semi-open cohort of 1,750 children aged 6 months at enrollment (included continuously for 7 months and all followed through to the end of the study, which will last 9 months in total).
2. Longitudinal follow-up of all children aged 6-23 months enrolled for wasting treatment, based on health system records.
3. Longitudinal follow-up at home for 6 months of a closed cohort of 700 children aged 6-23 months at inclusion, discharged from a treatment for acute malnutrition.
The primary impact results are as follows:
* The longitudinal prevalence of wasting at the end of the study (Cohort 1).
* The recovery rate (Cohort 2).
* The incidence of relapse during the 11 months of the intervention (Cohort 3).
Secondary impact results include, but are not limited to :
* The incidence of wasting during the 11 months of the intervention (Cohort 1) ;
* The screening coverage (cohorts 1 and 3);
* The proportion of wasting cases enrolled in a treatment program (cohorts 1 and 3);
* The adherence to treatment (cohort 2) during the 11 months of the intervention.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: