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Clinical Trials/NCT02486523
NCT02486523
Completed
N/A

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

Action Contre la Faim1 site in 1 country1,572 target enrollmentApril 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Severe Malnutrition
Sponsor
Action Contre la Faim
Enrollment
1572
Locations
1
Primary Endpoint
Difference in the proportion of post-recovery relapse cases
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
May 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mathias Altmann

Dr

Action Contre la Faim

Eligibility Criteria

Inclusion Criteria

  • Not provided

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

Outcomes

Primary Outcomes

Difference in the proportion of post-recovery relapse cases

Time Frame: 2 months and 6 months after successful OTP discharge

This is a dichotomous variable based on whether a child discharged as cured from the OTP program has a new event of acute malnutrition during the 6 months following the discharge. The relapse proportion for each group = \[Total number of relapsing children\] / \[total number of discharged children that have been followed up\] Relative reduction of 42% (from 12% to 7%) is expected.

Secondary Outcomes

  • Difference in the average weight gain at the OTP discharge(an expected average is between 7 and 8 weeks)
  • Diarrhoea Incidence(up to 6 months follow up)
  • Difference in the length of stay in the OTP(an expected average is between 7 and 8 weeks.)
  • Difference in the anthropocentric measurements (WHZ, HAZ, WAZ)(up to 6 months after OTP discharge)

Study Sites (1)

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