Severe MalnutritionOUADINUTNCT02486523
Benefits of a Household WASH Package to Community-based Management of Acute Malnutrition (CMAM) Program, Chad
A study testing Hygiene promotion sessions, Household WASH package and Household visit in people with Severe Malnutrition, run by Action Contre la Faim at 1 site in Chad.
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. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Severe Malnutrition
- What is being tested?
- Hygiene promotion sessions, Household WASH package and Household visit
- Type of treatment
- Medical device, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,572 participants
- Where
- 1 siteChad
- Study dates
- Apr 2015to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
Show all 10Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Chad1 site
Health centers
Mao, Kanem Region
About this study
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).
Read the 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.
- Conditions
- Severe Malnutrition
- Being tested
- Hygiene promotion sessions, Household WASH package, Household visit, Group discussions after successful discharge, Outpatient Therapeutic Programme
- Keywords
- SAM, severe acute malnutrition
- Medical subject headings
- Malnutrition, Severe Acute Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hygiene promotion sessionsBehavioural
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.
Household WASH packageDevice
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.
Household visitBehavioural
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 dischargeBehavioural
Group discussions on hygiene and care practices with mothers at the community level after successful discharge.
Outpatient Therapeutic ProgrammeProcedure or surgery
Home-based treatment and rehabilitation using Ready-to-use Therapeutic Food (RUTF) for children with severe acute malnutrition
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Group discussions after successful discharge; Procedure: 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 Receives: Behavioral: Hygiene promotion sessions; Device: Household WASH package; Behavioral: Household visit; Behavioral: Group discussions after successful discharge; Procedure: Outpatient Therapeutic Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months and 6 months after successful OTP discharge
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: an expected average is between 7 and 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startApr 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,572 participants (actual)
Sponsor and investigators
- Lead sponsor
- Action Contre la Faim
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Tropical Medicine, Belgium, Association Sahélienne de Recherches Appliquées pour le Développement Durable
- Responsible party
- Principal investigator, Mathias Altmann, Action Contre la Faim
- Investigators
- Mathias Altmann, Dr, Principal investigator, ACTION CONTRE LA FAIM | ACF-France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02486523
- Sponsor's protocol ID
- DFI.1836-554994
- Acronym
- OUADINUT
- Status last verified
- Sep 2016
- First submitted
- 26 May 2015
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of a Household WASH Package to Community-based Management of Acute Malnutrition (CMAM) Program, Chad
- ClinicalTrials.gov ID
- NCT02486523
- Acronym / sponsor ID
- OUADINUT / DFI.1836-554994
- Conditions
- Severe Malnutrition
- Keywords
- SAM, severe acute malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,572 participants (actual)
- Lead sponsor
- Action Contre la FaimUniversity, hospital or other
- Collaborators
- Institute of Tropical Medicine, Belgium, Association Sahélienne de Recherches Appliquées pour le Développement Durable
- Study start
- Apr 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 1 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Behavioral: Group discussions after successful discharge, Procedure: Outpatient Therapeutic ProgrammeOutpatient management of children diagnosed with severe acute malnutrition. Interventions allocated: Behavioral: Group discussions after successful discharge Procedure/Surgery: Outpatient Therapeutic Programme |
| Intervention group | Experimental | Behavioral: Hygiene promotion sessions, Device: Household WASH package, Behavioral: Household visit, Behavioral: Group discussions after successful discharge, Procedure: Outpatient Therapeutic ProgrammeOutpatient 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 |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Children aged between 6 to 59 months
- New admission:
- Other admission:
- Caretakers' agreement to participate (through an informed consent)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hygiene promotion sessionsHygiene 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. | Behavioural | Intervention group |
| Household WASH packageThe 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. | Device | Intervention group |
| Household visitA 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. | Behavioural | Intervention group |
| Group discussions after successful dischargeGroup discussions on hygiene and care practices with mothers at the community level after successful discharge. | Behavioural | Control group, Intervention group |
| Outpatient Therapeutic ProgrammeHome-based treatment and rehabilitation using Ready-to-use Therapeutic Food (RUTF) for children with severe acute malnutrition | Procedure or surgery | Control group, Intervention group |
Primary outcome
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.
4 secondary outcomes
Difference in the average weight gain at the OTP discharge
Time frame: an expected average is between 7 and 8 weeks
Difference in the anthropocentric measurements (WHZ, HAZ, WAZ)
Time frame: up to 6 months after OTP discharge
Diarrhoea Incidence
Time frame: up to 6 months follow up
Difference in the length of stay in the OTP
Time frame: an expected average is between 7 and 8 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathias Altmann, Dr principal investigator
ACTION CONTRE LA FAIM | ACF-France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hygiene promotion sessions, Household WASH package and Household visit in people with Severe Malnutrition, run by Action Contre la Faim at 1 site in Chad.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chad. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the proportion of post-recovery relapse cases (time frame: 2 months and 6 months after successful OTP discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2016.