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

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).

Study Overview

• Status: Completed
• Conditions: Severe Malnutrition
• Intervention / Treatment: Behavioral: Group discussions after successful discharge; Procedure: Outpatient Therapeutic Programme; Behavioral: Hygiene promotion sessions; Device: Household WASH package; Behavioral: Household visit

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.

• Study Type: Interventional
• Enrollment (Actual): 1572
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chad
  • Kanem
    • Mao, Kanem, Chad
      • Health Centers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Outpatient management of children diagnosed with severe acute malnutrition. Interventions allocated: Behavioral: Group discussions after successful discharge Procedure/Surgery: Outpatient Therapeutic Programme	Behavioral: Group discussions after successful discharge; Group discussions on hygiene and care practices with mothers at the community level after successful discharge.; Procedure: Outpatient Therapeutic Programme; Home-based treatment and rehabilitation using Ready-to-use Therapeutic Food (RUTF) for children with severe acute malnutrition
Experimental: 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	Behavioral: Group discussions after successful discharge; Group discussions on hygiene and care practices with mothers at the community level after successful discharge.; Procedure: Outpatient Therapeutic Programme; Home-based treatment and rehabilitation using Ready-to-use Therapeutic Food (RUTF) for children with severe acute malnutrition; Behavioral: 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.; Device: 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.; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in the proportion of post-recovery relapse cases	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.	2 months and 6 months after successful OTP discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in the average weight gain at the OTP discharge	The weight gain (g/kg/day) = [weight (g) at discharge - minimum weight (g)] / [Duration from minimum weight to discharge] * [minimum weight (kg)]. The average weight gain (g/kg/day) for each group = [Sum of weight gains of cured children] / [total number of cured children]. Increase of 3 g/kg/day is expected.	an expected average is between 7 and 8 weeks
Difference in the anthropocentric measurements (WHZ, HAZ, WAZ)	Weight for Height Z-score (WHZ), Height for age Z-score (HAZ) and Weight for age Z-score (WAZ) and Mid-upper-arm circumference (MUAC) Increase of 0,2 Z-score 6 months after OTP discharge is expected.	up to 6 months after OTP discharge
Diarrhoea Incidence	Loose or watery stools at least three times per day during the week/month prior to the consultation or visit.	up to 6 months follow up
Difference in the length of stay in the OTP	The OTP length of stay is the total number of days spent in the program, from admission of the child to the discharge of a cured child. The average length of stay for all children in each group = [total number of days of cured children] / [number of cured children]. Reduction of 5 days is expected.	an expected average is between 7 and 8 weeks.

Collaborators and Investigators

• Sponsor: Action Contre la Faim
• Collaborators: Institute of Tropical Medicine, Belgium; Association Sahélienne de Recherches Appliquées pour le Développement Durable
• Investigators: Principal Investigator: Mathias Altmann, Dr, ACTION CONTRE LA FAIM | ACF-France

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: May 26, 2015
• First Submitted That Met QC Criteria: June 30, 2015
• First Posted (Estimate): July 1, 2015

Study Record Updates

• Last Update Posted (Estimate): September 7, 2016
• Last Update Submitted That Met QC Criteria: September 6, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: SAM, severe acute malnutrition
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: DFI.1836-554994