Does treatment for severe malnutrition make children who are short for their age overweight?

ISRCTN ISRCTN92405176
DOI https://doi.org/10.1186/ISRCTN92405176
Secondary identifying numbers 4001-08-1-01/4001-VALID- 00/Task Order 4.
Submission date
19/04/2018
Registration date
15/05/2018
Last edited
19/12/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Mr Paul Binns
Scientific

Prestwich
Manchester
M25
United Kingdom

ORCiD logoORCID ID 0000-0001-8005-9835

Study information

Study designSingle-centre observational cross-sectional cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Community
Study typeOther
Participant information sheet No participant information sheet available
Scientific titleDoes 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?
Study objectivesHeight 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(s)National Health Sciences Research Committee of Malawi, 30/11/2010, Protocol #817 MED/4/36c
Health condition(s) or problem(s) studiedOverweight following treatment for severe acute malnutrition
InterventionChildren 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 typeOther
Primary outcome measureWeight for height z-score on discharge
Secondary outcome measures1. 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 study start date16/12/2008
Completion date18/12/2013

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit6 Months
Upper age limit59 Months
SexBoth
Target number of participantsN/A
Key inclusion criteria1. 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
Key exclusion criteria1. Aged <6 months or >59 months
2. MUAC >11.5cm
3. Anorexia
4. Any medical complication requiring transfer to hospital
5. Refusal of consent
Date of first enrolment01/03/2011
Date of final enrolment29/03/2012

Locations

Countries of recruitment

  • Malawi

Study participating centre

Lilongwe Ditrict
N/A
Malawi

Sponsor information

Valid International
Research organisation

35 Leopold Street
Oxford
OX4 1TW
United Kingdom

ROR logo "ROR" https://ror.org/00sb6vz77

Funders

Funder type

Not defined

FHI 360
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
Family Health International
Location
United States of America
Valid International

No information available

Results and Publications

Intention to publish date31/05/2018
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planSubmitted for peer review April 2018
IPD sharing planThe 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.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 13/12/2018 Yes No

Editorial Notes

19/12/2018: Publication reference added.