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

Primary Purpose

Severe Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Chad
Study Type
Interventional
Intervention
Hygiene promotion sessions
Household WASH package
Household visit
Group discussions after successful discharge
Outpatient Therapeutic Programme
Sponsored by
Action Contre la Faim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Malnutrition focused on measuring SAM, severe acute malnutrition

Eligibility Criteria

6 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Health centers

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Intervention group

Arm Description

Outpatient management of children diagnosed with severe acute malnutrition. Interventions allocated: Behavioral: Group discussions after successful discharge Procedure/Surgery: Outpatient Therapeutic Programme

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Diarrhoea Incidence
Loose or watery stools at least three times per day during the week/month prior to the consultation or visit.
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.

Full Information

First Posted
May 26, 2015
Last Updated
September 6, 2016
Sponsor
Action Contre la Faim
Collaborators
Institute of Tropical Medicine, Belgium, Association Sahélienne de Recherches Appliquées pour le Développement Durable
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1. Study Identification

Unique Protocol Identification Number
NCT02486523
Brief Title
Benefits of a Household WASH Package to Community-based Management of Acute Malnutrition (CMAM) Program, Chad
Acronym
OUADINUT
Official Title
Benefits of a Household WASH Package to Community-based Management of Acute Malnutrition (CMAM) Program, Chad
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Action Contre la Faim
Collaborators
Institute of Tropical Medicine, Belgium, Association Sahélienne de Recherches Appliquées pour le Développement Durable

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: Control group: outpatient management of children diagnosed for severe acute malnutrition only 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Malnutrition
Keywords
SAM, severe acute malnutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1572 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Outpatient management of children diagnosed with severe acute malnutrition. Interventions allocated: Behavioral: Group discussions after successful discharge Procedure/Surgery: Outpatient Therapeutic Programme
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Hygiene promotion sessions
Intervention Description
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
Device
Intervention Name(s)
Household WASH package
Intervention Description
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
Behavioral
Intervention Name(s)
Household visit
Intervention Description
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
Intervention Name(s)
Group discussions after successful discharge
Intervention Description
Group discussions on hygiene and care practices with mothers at the community level after successful discharge.
Intervention Type
Procedure
Intervention Name(s)
Outpatient Therapeutic Programme
Intervention Description
Home-based treatment and rehabilitation using Ready-to-use Therapeutic Food (RUTF) for children with severe acute malnutrition
Primary Outcome Measure Information:
Title
Difference in the proportion of post-recovery relapse cases
Description
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.
Time Frame
2 months and 6 months after successful OTP discharge
Secondary Outcome Measure Information:
Title
Difference in the average weight gain at the OTP discharge
Description
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.
Time Frame
an expected average is between 7 and 8 weeks
Title
Difference in the anthropocentric measurements (WHZ, HAZ, WAZ)
Description
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.
Time Frame
up to 6 months after OTP discharge
Title
Diarrhoea Incidence
Description
Loose or watery stools at least three times per day during the week/month prior to the consultation or visit.
Time Frame
up to 6 months follow up
Title
Difference in the length of stay in the OTP
Description
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.
Time Frame
an expected average is between 7 and 8 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathias Altmann, Dr
Organizational Affiliation
ACTION CONTRE LA FAIM | ACF-France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health centers
City
Mao
State/Province
Kanem
Country
Chad

12. IPD Sharing Statement

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

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