NCT02486523

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. 1.Control group: outpatient management of children diagnosed for severe acute malnutrition only
  2. 2.Intervention group: outpatient management of children diagnosed for severe acute malnutrition + "household WASH package"

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,572

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

September 7, 2016

Status Verified

September 1, 2016

Enrollment Period

1.1 years

First QC Date

May 26, 2015

Last Update Submit

September 6, 2016

Conditions

Keywords

SAM, severe acute malnutrition

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Difference in the average weight gain at the OTP discharge

    an expected average is between 7 and 8 weeks

  • Difference in the anthropocentric measurements (WHZ, HAZ, WAZ)

    up to 6 months after OTP discharge

  • 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.

Study Arms (2)

Control group

ACTIVE COMPARATOR

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 dischargeProcedure: Outpatient Therapeutic Programme

Intervention group

EXPERIMENTAL

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: Hygiene promotion sessionsDevice: Household WASH packageBehavioral: Household visitBehavioral: Group discussions after successful dischargeProcedure: Outpatient Therapeutic Programme

Interventions

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 group

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 group
Household visitBEHAVIORAL

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 group

Group discussions on hygiene and care practices with mothers at the community level after successful discharge.

Control groupIntervention group

Home-based treatment and rehabilitation using Ready-to-use Therapeutic Food (RUTF) for children with severe acute malnutrition

Control groupIntervention group

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health centers

Mao, Kanem Region, Chad

Location

MeSH Terms

Conditions

MalnutritionSevere Acute Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Mathias Altmann, Dr

    ACTION CONTRE LA FAIM | ACF-France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

May 26, 2015

First Posted

July 1, 2015

Study Start

April 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

September 7, 2016

Record last verified: 2016-09

Locations