Research protocol local ingredients-based supplementary food as an alternative to corn-soya blends plus for treating moderate acute malnutrition among children aged 6 to 59 months: a randomized controlled non-inferiority trial in Wolaita.
BMC Public Health
; 19(1): 1689, 2019 Dec 16.
Article
em En
| MEDLINE
| ID: mdl-31842852
ABSTRACT
BACKGROUND:
In Ethiopia, 12.5% of children below 5 years are wasted, and 9.7% are moderately wasted. The present strategy for the management of moderate acute malnutrition (MAM) is a supplementary feeding program; however, this is only provided to chronically food-insecure areas. This randomized controlled non-inferiority trial examines if Local ingredients-based supplement (LIBS) is as effective as corn-soya blends plus (CSB+) in treating moderate acute malnutrition among children aged 6-59 months.METHODS:
A randomized controlled non-inferiority trial will be conducted with moderately wasted children aged 6 to 59 months in Wolaita, Ethiopia. The calculated sample size is 324 (i.e. with 162 children in each of two arms, to be assigned by randomization). The daily ration will be 100 g of LIBS plus 25.2 g of sugar with 8 ml oil in the intervention group, and 150 g of CSB+ with 16 ml of oil in the control group. These interventions will be provided for a maximum period of 12 weeks, with follow-up performed on a weekly basis. Data analysis will be done using SPSS and STATA software. Both intention-to-treat and per protocol analyses will be done. Hazard ratio and Kaplan-Meier (log rank) curves of survival analysis will be done to predict the probability of recovery rate. Logistic regression will be used to test for interactions between independent and dependent variables. Analysis of variances, t-tests, fisher's exact test and chi-square tests will be used to assess baseline characteristics.CONCLUSIONS:
This paper will introduce to the existing research locally available nutritious foods which have the potential to enhance recovery from moderate acute malnutrition and to reduce the burden of malnutrition. The perceptions of mothers on feeding children with local ingredient-based supplementary food to assist recovery from moderate acute malnutrition will be the focus of in a qualitative study to follow; this will provide a further contribution in an evolving area of research. TRIAL REGISTRATION Pan-African Clinical Trial Registration number PACTR201809662822990, retrospectively registered on 11/09/2018.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Transtornos da Nutrição Infantil
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Suplementos Nutricionais
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Ingredientes de Alimentos
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Fenômenos Fisiológicos da Nutrição do Lactente
Tipo de estudo:
Clinical_trials
/
Guideline
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Prognostic_studies
/
Qualitative_research
Limite:
Child, preschool
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Humans
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Infant
País/Região como assunto:
Africa
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article