MalnutritionMàLÉNCT01863394
Evaluation of Two Community Based Screening Strategies for Severe Acute Malnutrition in Children 6-59 Months in Mirria District, Niger
A study testing Screening by mothers and Active comparator: Screening by community health workers in people with Malnutrition, run by Alliance for International Medical Action at 1 site in Niger.
Trial summary
The objective of this study is to determine the efficacity of a community strategy for screening children 06-59 months old for Severe Acute Malnutrition (SAM) conducted by their mothers' compared with a community screening strategy conducted by Community Health Workers. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Malnutrition
- What is being tested?
- Screening by mothers and Active comparator: Screening by community health workers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,429 participants
- Where
- 1 siteNiger
- Study dates
- May 2013to Apr 2014
- 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 06-59 months at the time of the study
- children who live in a village in the health district participating in the study
Who cannot join
- children whose legal guardian refuses to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Two Community Based Screening Strategies for Severe Acute Malnutrition in Children Aged 6-59 Months in the Mirria District, Niger
The objective of this study is to determine the efficacity of a community strategy for screening children 06-59 months old for Severe Acute Malnutrition (SAM) conducted by their mothers' compared with a community screening strategy conducted by Community Health Workers.
- Conditions
- Malnutrition
- Being tested
- Screening by mothers, Active comparator: Screening by community health workers
- Keywords
- Screening, Malnutrition, Community Management of Acute Malnutrition
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening by mothersOther
Active comparator: Screening by community health workersOther
| Study group | Role | What they receive |
|---|---|---|
| Screening by community health workers | Active comparator | One Community Health Worker (CHW) will be trained per village in the comparator arm. The training the CHWs receive will be identical to that delivered in the Community Management of Acute Malnutrition program run by ALIMA/BEFEN (Bien Être de la Femme et l'Enfant Niger) over the last 3 years. This involves 6 hours theoretical training and a practical session in the health centre.
CHWs will screen children 06-59 months in their village once a month Receives: Other: Active comparator: Screening by community health workers |
| Screening by mothers | Experimental | Mothers in the intervention health district will be trained in small womens' groups in their village. Training will have a theoretical component and a practical demonstration component on children in the village
During the first baseline door to door mass screening campaign, mothers will also receive individual training on conducting a Mid Upper Arm Circumference (MUAC) classification and looking for pedal oedema. they will receive a brief recap during the three monthly door-to-door mass screening campaigns
Mothers will be asked to check their child's MUAC and look for pedal oedema
* whenever the child does not seem to be in 'good health' to the mother
* whenever the mother feels that the child is 'unwell' or 'sick'
* whenever it seems to the mother that her child has lost weight
* whenever the mother thinks that it is necessary to do so Receives: Other: Screening by mothers |
What is being measured
The primary outcome is the main question the study is designed to answer.
The coverage of the therapeutic nutritional program in the control and intervention health districts
Coverage of the the therapeutic nutritional treatment program is defined as the proportion of children 06-59 months with Severe Acute Malnutrition (Mid Upper Arm Circumference <115mm and/or oedema) receiving treatment in the program, amongst the total number of children diagnosed with Severe Acute Malnutrition
Measured: 12 months
Secondary outcomes (1)
Malnutrition program data for children referred by community health workers & mothers
Nutritional status at admission (mid upper arm circumference +/- oedema) Type of admission to the programme (out-patient or immediate transfer for in-patient care) Source of reference to the programme (Community Health Worker, Mother, other) Date of discharge from the programme Weight at admission to the programme Discharge criteria (cured, died, failed to attend, non-response to treatment, transfer for in-patient nutrition care, transfer to other health care structures) Number of children screened by mothers confirmed to have SAM at the treatment centre Number of children screened by community health workers confirmed to have SAM at the treatment centre
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startMay 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,429 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alliance for International Medical Action
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission
- Responsible party
- Sponsor
- Investigators
- Nikki BLACKWELL, FCICM, Principal investigator, Alliance for International Medical ActionIsabelle Defourney, MBBS, Study director, Alliance for International Medical Action
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863394
- Sponsor's protocol ID
- MUAC À L'ÉCHELLE
- Acronym
- MàLÉ
- Status last verified
- Jul 2014
- First submitted
- 7 May 2013
- Last updated
- 15 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ale FG, Phelan KP, Issa H, Defourny I, Le Duc G, Harczi G, Issaley K, Sayadi S, Ousmane N, Yahaya I, Myatt M, Briend A, Allafort-Duverger T, Shepherd S, Blackwell N. Mothers screening for malnutrition by mid-upper arm circumference is non-inferior to community health workers: results from a large-scale pragmatic trial in rural Niger. Arch Public Health. 2016 Sep 6;74(1):38. doi: 10.1186/s13690-016-0149-5. eCollection 2016.
PubMed 27602207
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Two Community Based Screening Strategies for Severe Acute Malnutrition in Children Aged 6-59 Months in the Mirria District, Niger
- ClinicalTrials.gov ID
- NCT01863394
- Acronym / sponsor ID
- MàLÉ / MUAC À L'ÉCHELLE
- Conditions
- Malnutrition
- Keywords
- Screening, Malnutrition, Community Management of Acute Malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,429 participants (estimated)
- Lead sponsor
- Alliance for International Medical ActionUniversity, hospital or other
- Collaborators
- European Commission
- Study start
- May 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 29 May 2013 (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 this study is to determine the efficacity of a community strategy for screening children 06-59 months old for Severe Acute Malnutrition (SAM) conducted by their mothers' compared with a community screening strategy conducted by Community Health Workers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Screening by community health workers | Active comparator | Other: Active comparator: Screening by community health workersOne Community Health Worker (CHW) will be trained per village in the comparator arm. The training the CHWs receive will be identical to that delivered in the Community Management of Acute Malnutrition program run by ALIMA/BEFEN (Bien Être de la Femme et l'Enfant Niger) over the last 3 years. This involves 6 hours theoretical training and a practical session in the health centre. CHWs will screen children 06-59 months in their village once a month |
| Screening by mothers | Experimental | Other: Screening by mothersMothers in the intervention health district will be trained in small womens' groups in their village. Training will have a theoretical component and a practical demonstration component on children in the village During the first baseline door to door mass screening campaign, mothers will also receive individual training on conducting a Mid Upper Arm Circumference (MUAC) classification and looking for pedal oedema. they will receive a brief recap during the three monthly door-to-door mass screening campaigns Mothers will be asked to check their child's MUAC and look for pedal oedema * whenever the child does not seem to be in 'good health' to the mother * whenever the mother feels that the child is 'unwell' or 'sick' * whenever it seems to the mother that her child has lost weight * whenever the mother thinks that it is necessary to do so |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children aged 06-59 months at the time of the study
- children who live in a village in the health district participating in the study
Key exclusion criteria (1 listed)
- children whose legal guardian refuses to participate in the study
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 |
|---|---|---|
| Screening by mothers | Other | Screening by mothers |
| Active comparator: Screening by community health workers | Other | Screening by community health workers |
Primary outcome
The coverage of the therapeutic nutritional program in the control and intervention health districts
Time frame: 12 months
Coverage of the the therapeutic nutritional treatment program is defined as the proportion of children 06-59 months with Severe Acute Malnutrition (Mid Upper Arm Circumference <115mm and/or oedema) receiving treatment in the program, amongst the total number of children diagnosed with Severe Acute Malnutrition
1 secondary outcome
Malnutrition program data for children referred by community health workers & mothers
Time frame: 12 months
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 15 Jul 2014.
- Derived from this study: PubMed 27602207Ale FG, Phelan KP, Issa H, Defourny I, Le Duc G, Harczi G, Issaley K, Sayadi S, Ousmane N, Yahaya I, Myatt M, Briend A, Allafort-Duverger T, Shepherd S, Blackwell N. Mothers screening for malnutrition by mid-upper arm circumference is non-inferior to community health workers: results from a large-scale pragmatic trial in rural Niger. Arch Public Health. 2016 Sep 6;74(1):38. doi: 10.1186/s13690-016-0149-5. eCollection 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.
Nikki BLACKWELL, FCICM principal investigator
Alliance for International Medical Action
Isabelle Defourney, MBBS study director
Alliance for International Medical Action
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening by mothers and Active comparator: Screening by community health workers in people with Malnutrition, run by Alliance for International Medical Action at 1 site in Niger.
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 2 inclusion and 1 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 15 Jul 2014. 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 Niger. 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?
The coverage of the therapeutic nutritional program in the control and intervention health districts (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01863394, which also lists 1 linked publication.
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 15 Jul 2014.