Plain English Summary
Background and study aims
A child that becomes severely thin due to malnutrition requires specialised treatment with medicines and a ready-to eat food (RUTF) that contains all of the necessary ingredients for recovery. Children can be identified for treatment using a tape that measures the circumference at the middle of the upper part of the arm. A potential problem is that if a child is very small for their age, the measurement of the arm might indicate that the child needs treatment when in fact the child has a small circumference because they are small for their age and may not be malnourished. The ready to eat food contains a lot of oil and it is a concern that giving this specialised food to small children who may not be malnourished might cause them to become overweight or develop too much fat as a result of treatment. Obesity is a risk factor for diseases in later life. The aim of this study is to identify whether giving treatment to children who have been identified using the measurement of the arm and are short for their age causes them to become overweight or have more fat than normal following treatment.
Who can participate?
The study recruited all children between the ages of 6 to 59 months who were identified as having severe malnutrition using measurement of the upper arm circumference and were admitted to a treatment programme for malnutrition.
What does the study involve?
The treatment given to the study participants was identical to the treatment given to any severely malnourished child being treated in Ministry of Health clinics in Malawi. The children were discharged as cured according to national guidelines for treatment. For study participants, additional measurements were made of the thickness of a fold of fat on the upper arm (the Triceps Skin Fold).
What are the possible benefits and risks of participating?
The treatment followed standard government guidelines and was no different to the treatment offered to children not enrolled in the study. No incentives were given for participation and there was no additional risk attached to participation in the study.
Where is the study run from?
The study participants were recruited from a total of five Ministry of Health clinics in Lilongwe District in Malawi: Nsaru, Nthondo, Nathenje, Chiwamba and Chilobwe.
When is the study starting and how long is it expected to run for?
The study enrolled children from March 2011 to March 2012.
Who is funding the study?
Family Health International (FHI 360) Food and Nutritional Technical Assistance. The cost of the Harpeneden Calipers was met by Valid International Ltd.
Who is the main contact?
Paul Binns, paulbinns@gmx.com
Trial website
Contact information
Type
Scientific
Primary contact
Mr Paul Binns
ORCID ID
http://orcid.org/0000-0001-8005-9835
Contact details
Prestwich
Manchester
M25
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
4001-08-1-01/4001-VALID- 00/Task Order 4.
Study information
Scientific title
Does treatment for severe acute malnutrition for children aged 6-59 months, identified by Mid-Upper Arm Circumference and that are less than 65 cm or have low height for age and treated with Ready to Use Therapeutic Food cause the child to become overweight or obese following cure?
Acronym
Study hypothesis
Height cut-offs are frequently used as a proxy for an age of 6 months to identify infants not eligible for treatment with ready-to-use therapeutic foods (RUTF) although this may exclude stunted children aged 6 months or older. This study examined whether stunted children aged 6 months or older with severe acute malnutrition (SAM), identified by mid-upper arm circumference (MUAC), and treated with RUTF were overweight or had excess adiposity following cure.
Ethics approval
National Health Sciences Research Committee of Malawi, 30/11/2010, Protocol #817 MED/4/36c
Study design
Single-centre observational cross-sectional cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Community
Trial type
Other
Patient information sheet
No participant information sheet available
Condition
Overweight following treatment for severe acute malnutrition
Intervention
Children aged 6 to 59 months were enrolled in outpatient treatment for SAM if they had a MUAC less than 115 mm without medical complications irrespective of height on admission. 163 children were discharged as cured when a MUAC of 125 mm or greater was obtained for 2 consecutive clinic visits and the child was clinically well. MUAC, triceps skin fold (TSF) thickness and weight were measured at each visit and height was measured on admission and discharge.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Weight for height z-score on discharge
Secondary outcome measures
1. Triceps skin fold for age z-score on discharge
2. Arm fat index for age z-score on discharge
3. Weight for age z score on discharge
Overall trial start date
16/12/2008
Overall trial end date
18/12/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 6 - 59 months
2. Mid upper arm circumference <11.5cm
3. Good appetite for ready-to-use therapeutic food
4. No medical complications requiring transfer to hospital
5. Consent from carer to participate
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
N/A
Participant exclusion criteria
1. Aged <6 months or >59 months
2. MUAC >11.5cm
3. Anorexia
4. Any medical complication requiring transfer to hospital
5. Refusal of consent
Recruitment start date
01/03/2011
Recruitment end date
29/03/2012
Locations
Countries of recruitment
Malawi
Trial participating centre
Lilongwe Ditrict
N/A
Malawi
Funders
Funder type
Not defined
Funder name
FHI 360
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Valid International
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Submitted for peer review April 2018
IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a publicly available repository (https://figshare.com/articles/MUAC_discharge_from_OTP_and_excess_adiposity/6200759 ). The study data is provided in Comma Separated Values (CSV) format. It is available now and will be available permanently to any user for any type of analysis. Participation in the study was by informed consent.
Intention to publish date
31/05/2018
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list
2018 results in https://www.ncbi.nlm.nih.gov/pubmed/30559964