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

Severe Malnutrition Clinical Trial

— OUADINUT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02486523
• Other study ID #: DFI.1836-554994
• Status: Completed
• Phase: N/A
• First received: May 26, 2015
• Last updated: September 6, 2016
• Start date: April 2015
• Est. completion date: May 2016

Study information

• Verified date: September 2016
• Source: Action Contre la Faim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1572
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 59 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malnutrition
• Severe Malnutrition

Intervention

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.
• 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

Locations

Country	Name	City	State
Chad	Health centers	Mao	Kanem

Sponsors (3)

Lead Sponsor	Collaborator
Action Contre la Faim	Association Sahélienne de Recherches Appliquées pour le Développement Durable, Institute of Tropical Medicine, Belgium

Country where clinical trial is conducted

Chad, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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.	No