Benefits of a Household WASH Package to Community-based Management of Acute Malnutrition (CMAM) Program, Chad

NCT ID: NCT02486523

Last Updated: 2016-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1572 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-05-31

Brief Summary

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The objective of the research is to assess the effectiveness of adding a Household WASH component to the standard outpatient treatment of severe acute malnutrition.

Study design: cluster-randomized controlled trial comparing two interventions:

1. Control group: outpatient management of children diagnosed for severe acute malnutrition only
2. Intervention group: outpatient management of children diagnosed for severe acute malnutrition + "household WASH package"

2000 children, aged between 6 and 59 months, admitted to 20 OTP (Outpatient Therapeutic Program) centers for SAM will be included into the study and followed for 8 months (2 months of treatment, and 6 months after successful discharge).

Detailed Description

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The Action Contre la Faim (ACF) nutrition project in Kanem started in 2008, and now is set up in 35 health facilities divided across 2 health districts: Mao and Mondo. The management of severe acute malnutrition is done in both OTP (Outpatient Therapeutic Programme) and in TFC (Therapeutic Feeding Center). Between the treatment of SAM in OTPs and TFCs, and the number of curative consultations, the total number of beneficiaries is expected to be 45,065 in 2014 (without double counting).

Clear evidence exists that some Water, Sanitation and Hygiene (WASH) interventions can successfully prevent diarrhea. For instance, interventions aiming at improving water quality at household level or at promoting hand washing with soap do reduce significantly diarrhea incidence. Estimations showed that WASH interventions have a small but measurable benefit on length growth, but not on weight or weight/height. Yet, to our knowledge, no impact of WASH interventions has been assessed, neither during nutritional rehabilitation where children are particularly vulnerable to infections, nor after discharge where immune recovery is still incomplete.

In the context of nutritional rehabilitation of SAM (Severe Acute Malnutrition), the investigators hypothesize that improving water quality and hygiene-related care practices at household level would decrease incidence of WASH-related infections, such as diarrhea, nematode and environmental enteropathy. As such, it would improve weight gain, decrease relapses after successful discharge, and overall, could decrease over time the incidence of acute malnutrition in the community.

The proposed WASH intervention will be added to already existing nutritional activities and it will include: i/ Household water treatment and hygiene kit (water container, water disinfection consumables, soap, cup, hygiene promotion leaflet) provided at beginning of SAM treatment; ii/ sessions of Hygiene promotion provided weekly at health center level iii/ Household visits and hygiene sessions made during the treatment; // group discussion on hygiene and care practices made with mother at community level after successful discharge.

Conditions

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Severe Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group

Outpatient management of children diagnosed with severe acute malnutrition.

Interventions allocated:

Behavioral: Group discussions after successful discharge Procedure/Surgery: Outpatient Therapeutic Programme

Group Type ACTIVE_COMPARATOR

Group discussions after successful discharge

Intervention Type BEHAVIORAL

Group discussions on hygiene and care practices with mothers at the community level after successful discharge.

Outpatient Therapeutic Programme

Intervention Type PROCEDURE

Home-based treatment and rehabilitation using Ready-to-use Therapeutic Food (RUTF) for children with severe acute malnutrition

Intervention group

Outpatient management of children diagnosed with severe acute malnutrition + "household WASH package"

Interventions allocated:

Behavioral: Hygiene promotion sessions Device: Household WASH package The content of the kit: soap and aquatab for 3 months, 20 liters Jerry can, a cup, a plastic kettle for hand washing and the instructions leaflet.

Behavioral: Household visits during the OTP phase Behavioral: Group discussions after successful discharge Procedure/Surgery: Outpatient Therapeutic Programme

Group Type EXPERIMENTAL

Hygiene promotion sessions

Intervention Type BEHAVIORAL

Hygiene promotion sessions are provided weekly to the caretakers at the health center level. They contain 7 main messages this study is trying to get across: Allocate a protected space for children to play, limiting the likelihood of them ingesting soil or animal feces; Wash the child with soap (hand, face) when outside the protected area; Cleaning and rapid burial of children's stools; Key times for hand washing with soap for the child caretaker; Store drinking water in a closed container located in an elevated place out of reach of animals; Drinking water provided to the child should be treated with chlorine or boiled; Once weaned, avoid giving to the child leftover food, or only after warming it again.

Household WASH package

Intervention Type DEVICE

The content of the kit: 200 g soap, aquatab 67 g, 20 liters Jerry can, a cup, a plastic kettle for hand washing and the instructions leaflet.

Household visit

Intervention Type BEHAVIORAL

A household visit conducted by village's community health volunteers and ACF intervention staff during and after the treatment, to provide refresh training on the messages and the use of the kit.

Group discussions after successful discharge

Intervention Type BEHAVIORAL

Group discussions on hygiene and care practices with mothers at the community level after successful discharge.

Outpatient Therapeutic Programme

Intervention Type PROCEDURE

Home-based treatment and rehabilitation using Ready-to-use Therapeutic Food (RUTF) for children with severe acute malnutrition

Interventions

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Hygiene promotion sessions

Hygiene promotion sessions are provided weekly to the caretakers at the health center level. They contain 7 main messages this study is trying to get across: Allocate a protected space for children to play, limiting the likelihood of them ingesting soil or animal feces; Wash the child with soap (hand, face) when outside the protected area; Cleaning and rapid burial of children's stools; Key times for hand washing with soap for the child caretaker; Store drinking water in a closed container located in an elevated place out of reach of animals; Drinking water provided to the child should be treated with chlorine or boiled; Once weaned, avoid giving to the child leftover food, or only after warming it again.

Intervention Type BEHAVIORAL

Household WASH package

The content of the kit: 200 g soap, aquatab 67 g, 20 liters Jerry can, a cup, a plastic kettle for hand washing and the instructions leaflet.

Intervention Type DEVICE

Household visit

A household visit conducted by village's community health volunteers and ACF intervention staff during and after the treatment, to provide refresh training on the messages and the use of the kit.

Intervention Type BEHAVIORAL

Group discussions after successful discharge

Group discussions on hygiene and care practices with mothers at the community level after successful discharge.

Intervention Type BEHAVIORAL

Outpatient Therapeutic Programme

Home-based treatment and rehabilitation using Ready-to-use Therapeutic Food (RUTF) for children with severe acute malnutrition

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Children aged between 6 to 59 months
* New admission:

* Weight for Height Z-score (WHZ) \< -3 (WHO2006) or
* MUAC \<115 mm or
* Presence of bilateral oedema (+ or ++ at OTP admission)
* Other admission:

* Relapse: after a successful discharge or ≥ 2 months since last visit
* Re-admission: defaulter \< 2 months since last visit
* Transfer from a stabilization center (SC)
* Caretakers' agreement to participate (through an informed consent)

Exclusion Criteria

* Signs of medical complications requiring inpatient management,
* Bilateral oedema (+++),
* Transfer from another OTP: treatment already started and child has a identification number (ID) for SAM
* Refusal of caretaker to participate
* Children from families outside the health center coverage
Minimum Eligible Age

6 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Tropical Medicine, Belgium

OTHER

Sponsor Role collaborator

Association Sahélienne de Recherches Appliquées pour le Développement Durable

OTHER

Sponsor Role collaborator

Action Contre la Faim

OTHER

Sponsor Role lead

Responsible Party

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Mathias Altmann

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mathias Altmann, Dr

Role: PRINCIPAL_INVESTIGATOR

ACTION CONTRE LA FAIM | ACF-France

Locations

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Health centers

Mao, Kanem Region, Chad

Site Status

Countries

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Chad

Other Identifiers

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DFI.1836-554994

Identifier Type: -

Identifier Source: org_study_id

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