MarasmusMUACNCT01790815
Mothers Understand And Can do it - Mid Upper Arm Circumference Screening for Malnutrition Performed by Mothers
An observational study of Marasmus and Kwashiorkor, run by Alliance for International Medical Action at 1 site in Niger.
Trial summary
PRIMARY OBJECTIVE : To determine whether mothers, given minimal group training, are capable of using a MUAC (mid-upper arm circumference) bracelet to screen their children for malnutrition and categorise them into one of three groups : 'red' (SAM ; severe acute malnutrition), 'yellow' (MAM ; moderate acute… Read more about this study
- Who is it for?
- Ages 6 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Marasmus, Kwashiorkor, Malnutrition; Degree, Moderate
- How many people
- 300 participants
- Where
- 1 siteNiger
- Study dates
- Aug 2011to Aug 2012
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Child
Study population: Children present in the inpatient malnutrition treatment unit and paediatric service of the Mirriah district hospital aged between 6-59 months old Children aged between 6-59 months old in the two villages of the Mirriah district, Niger; where the community phase of the study was conducted
Who may be able to join
- children present in the inpatient malnutrition treatment unit and paediatric service of the Mirriah district hospital aged between 6-59 months old
- children aged between 6-59 months old in the two villages where the community phase of the study was conducted
Who cannot join
- children receiving treatment in the intensive care unit of Mirriah district hospital
- children with bilateral oedema
- children whose mothers or fathers refused consent to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mothers Understand And Can do it - Mid Upper Arm Circumference Screening for Malnutrition Performed by Mothers of Children < 5 Years Old
PRIMARY OBJECTIVE :
To determine whether mothers, given minimal group training, are capable of using a MUAC (mid-upper arm circumference) bracelet to screen their children for malnutrition and categorise them into one of three groups : 'red' (SAM ; severe acute malnutrition), 'yellow' (MAM ; moderate acute malnutrition) or 'green' (normal nutritional status)
SECONDARY OBJECTIVES :
To establish whether there is a difference in the MUAC value if measured on the right arm as opposed to the left, in young children
To determine whether there is a difference in the MUAC value if the mid upper arm position is determined visually as opposed to being measured in the 'classical' fashion
Read the detailed description
Severe Acute Malnutrition (SAM) and its complications are major causes of death in under 5s in the developing world. A simple, reproducible, scalable way to recognise acute malnutrition and target early intervention would be a huge advance. Can mothers with limited training reliably measure and interpret the results of Mid Upper Arm Circumference (MUAC), a measurement performed with a MUAC measuring tape costing $0.06? MUAC contrasts with Z-score (WHZ), which requires both scales and a height gauge, both health worker interventions susceptible to considerable error, sensitive to non-nutritional factors, requiring calculations and growth curves, yet much less accurate in predicting risk of death compared with MUAC.
- Conditions
- Marasmus, Kwashiorkor, Malnutrition; Degree, Moderate, Malnutrition
- Keywords
- Acute Malnutrition, Mid Upper Arm Circumference, Screening
- Medical subject headings
- Protein-Energy Malnutrition, Kwashiorkor, Malnutrition, Lymphoma, Follicular
What is being measured
The primary outcome is the main question the study is designed to answer.
inter and intra observer variability
Variance in result of screening for malnutrition performed by mothers with minimal training compared to 'gold-standard' fully trained health care workers. Screening will be performed with a MUAC (mid-upper arm circumference) bracelet, results will be expressed by category: SAM (severe acute malnutrition), MAM (moderate acute malnutrition) or 'normal nutritional status
Measured: 2 years
Secondary outcomes (2)
inter and intra observer variability
The difference in millimetres in the MUAC value if measured on the right arm as opposed to the left ('classical method'), in young children
Measured: 2 years
inter and intra observer variability
The difference in the MUAC value in millimetres if the mid upper arm position is determined visually as opposed to being measured in the 'classical' fashion
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startAug 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MarasmusStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for International Medical Action
- Sponsor type
- University, hospital or other
- Collaborators
- Bien Être de La femme et de L'Enfant au Niger
- Responsible party
- Sponsor
- Investigators
- nikki blackwell, FCICM,FRACP, Study director, Alliance for International Medical Action
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790815
- Sponsor's protocol ID
- MUAC mères
- Acronym
- MUAC
- Status last verified
- Dec 2013
- First submitted
- 12 Feb 2013
- Last updated
- 10 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Briend A, Maire B, Fontaine O, Garenne M. Mid-upper arm circumference and weight-for-height to identify high-risk malnourished under-five children. Matern Child Nutr. 2012 Jan;8(1):130-3. doi: 10.1111/j.1740-8709.2011.00340.x. Epub 2011 Sep 28.
PubMed 21951349Briend A, Garenne M, Maire B, Fontaine O, Dieng K. Nutritional status, age and survival: the muscle mass hypothesis. Eur J Clin Nutr. 1989 Oct;43(10):715-26.
PubMed 2612460Blackwell N, Myatt M, Allafort-Duverger T, Balogoun A, Ibrahim A, Briend A. Mothers Understand And Can do it (MUAC): a comparison of mothers and community health workers determining mid-upper arm circumference in 103 children aged from 6 months to 5 years. Arch Public Health. 2015 May 18;73(1):26. doi: 10.1186/s13690-015-0074-z. eCollection 2015.
PubMed 25992287
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mothers Understand And Can do it - Mid Upper Arm Circumference Screening for Malnutrition Performed by Mothers of Children < 5 Years Old
- ClinicalTrials.gov ID
- NCT01790815
- Acronym / sponsor ID
- MUAC / MUAC mères
- Conditions
- Marasmus, Kwashiorkor, Malnutrition; Degree, Moderate, Malnutrition
- Keywords
- Acute Malnutrition, Mid Upper Arm Circumference, Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Alliance for International Medical ActionUniversity, hospital or other
- Collaborators
- Bien Être de La femme et de L'Enfant au Niger
- Study start
- Aug 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 13 Feb 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.
PRIMARY OBJECTIVE :
To determine whether mothers, given minimal group training, are capable of using a MUAC (mid-upper arm circumference) bracelet to screen their children for malnutrition and categorise them into one of three groups : 'red' (SAM ; severe acute malnutrition), 'yellow' (MAM ; moderate acute malnutrition) or 'green' (normal nutritional status)
SECONDARY OBJECTIVES :
To establish whether there is a difference in the MUAC value if measured on the right arm as opposed to the left, in young children
To determine whether there is a difference in the MUAC value if the mid upper arm position is determined visually as opposed to being measured in the 'classical' fashion
Detailed description
Severe Acute Malnutrition (SAM) and its complications are major causes of death in under 5s in the developing world. A simple, reproducible, scalable way to recognise acute malnutrition and target early intervention would be a huge advance. Can mothers with limited training reliably measure and interpret the results of Mid Upper Arm Circumference (MUAC), a measurement performed with a MUAC measuring tape costing $0.06? MUAC contrasts with Z-score (WHZ), which requires both scales and a height gauge, both health worker interventions susceptible to considerable error, sensitive to non-nutritional factors, requiring calculations and growth curves, yet much less accurate in predicting risk of death compared with MUAC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children present in the inpatient malnutrition treatment unit and paediatric service of the Mirriah district hospital aged between 6-59 months old Children aged between 6-59 months old in the two villages of the Mirriah district, Niger; where the community phase of the study was conducted
Key inclusion criteria (2 listed)
- children present in the inpatient malnutrition treatment unit and paediatric service of the Mirriah district hospital aged between 6-59 months old
- children aged between 6-59 months old in the two villages where the community phase of the study was conducted
Key exclusion criteria (3 listed)
- children receiving treatment in the intensive care unit of Mirriah district hospital
- children with bilateral oedema
- children whose mothers or fathers refused consent 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.
Primary outcome
inter and intra observer variability
Time frame: 2 years
Variance in result of screening for malnutrition performed by mothers with minimal training compared to 'gold-standard' fully trained health care workers. Screening will be performed with a MUAC (mid-upper arm circumference) bracelet, results will be expressed by category: SAM (severe acute malnutrition), MAM (moderate acute malnutrition) or 'normal nutritional status
2 secondary outcomes
inter and intra observer variability
Time frame: 2 years
inter and intra observer variability
Time frame: 2 years
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 10 Dec 2013.
- Background: PubMed 21951349Briend A, Maire B, Fontaine O, Garenne M. Mid-upper arm circumference and weight-for-height to identify high-risk malnourished under-five children. Matern Child Nutr. 2012 Jan;8(1):130-3. doi: 10.1111/j.1740-8709.2011.00340.x. Epub 2011 Sep 28.
- Background: PubMed 2612460Briend A, Garenne M, Maire B, Fontaine O, Dieng K. Nutritional status, age and survival: the muscle mass hypothesis. Eur J Clin Nutr. 1989 Oct;43(10):715-26.
- Derived from this study: PubMed 25992287Blackwell N, Myatt M, Allafort-Duverger T, Balogoun A, Ibrahim A, Briend A. Mothers Understand And Can do it (MUAC): a comparison of mothers and community health workers determining mid-upper arm circumference in 103 children aged from 6 months to 5 years. Arch Public Health. 2015 May 18;73(1):26. doi: 10.1186/s13690-015-0074-z. eCollection 2015.
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,FRACP 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?
An observational study of Marasmus and Kwashiorkor, 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 3 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 10 Dec 2013. 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?
inter and intra observer variability (time frame: 2 years). 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 NCT01790815, which also lists 3 linked publications.
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 10 Dec 2013.