Clinical trial NCT02486523: Benefits of a Household WASH Package to Community-based Management of Acute Malnutrition (CMAM) Program, Chad
Official title: Benefits of a Household WASH Package to Community-based Management of Acute Malnutrition (CMAM) Program, Chad
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Malnutrition
Keywords: SAM, severe acute malnutrition
Lead sponsor: Action Contre la Faim
Sponsor class: OTHER
Collaborators: name: Institute of Tropical Medicine, Belgium
name: Association Sahélienne de Recherches Appliquées pour le Développement Durable
First posted: 2015-07-01
Enrollment: 1572
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in the proportion of post-recovery relapse cases
timeFrame: 2 months and 6 months after successful OTP discharge
Secondary outcomes:
measure: Difference in the average weight gain at the OTP discharge
timeFrame: an expected average is between 7 and 8 weeks
measure: Difference in the anthropocentric measurements (WHZ, HAZ, WAZ)
timeFrame: up to 6 months after OTP discharge
measure: Diarrhoea Incidence
timeFrame: up to 6 months follow up
measure: Difference in the length of stay in the OTP
timeFrame: an expected average is between 7 and 8 weeks.
Other outcomes:
Locations:
city: Mao
country: Chad
facility: Health centers
state: Kanem
Study officials:
affiliation: ACTION CONTRE LA FAIM | ACF-France
name: Mathias Altmann, Dr
role: PRINCIPAL_INVESTIGATOR
References: