Treating Moderate Malnutrition in 6-24 Months Old Children
Condition: Moderate Acute Malnutrition
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      Child malnutrition is intimately associated to poverty and may be due to sub-optimal feeding
      behaviours, food insecurity at household level, or a combination of both. Acute malnutrition
      is a major contributor to under-5 mortality and morbidity in developing countries. While
      clinical guidelines for severe acute malnutrition (SAM) have been available for a decade,
      research on the management of moderate acute malnutrition (MAM) has lagged behind.
      Nonetheless, MAM is much more incident than SAM, it increases mortality risk by itself and
      requires special nutritional treatment. This study is thus meant to address this major gap,
      by testing the relative feasibility, effectiveness and cost-effectiveness of three innovative
      strategies for treating children with MAM aged 6-24 months : a locally produced Ready-to-Use
      Therapeutic Food (RUTF), a corn/soy blended flour (CSB++)provided by the World Food Program,
      and a specific and context-appropriate child-centred counselling.

      The evaluation will be carried out as a cluster-randomized trial in the Houndé district,
      Burkina Faso, where 18 rural health centres will be randomly allocated to RUSF or CSB or CCC
      for treating MAM.
    

Detailed description: 
      Child malnutrition is intimately associated to poverty and may be due to sub-optimal feeding
      behaviours, food insecurity at household level, or a combination of both. Acute malnutrition
      is a major contributor to under-5 mortality and morbidity in low and middle income countries.
      Clinical guidelines for the management of severe acute malnutrition (SAM) have been available
      for a decade and have yielded excellent results. However, the corresponding research on the
      management of moderate acute malnutrition (MAM) has lagged behind, even if MAM is much more
      incident than SAM, increases mortality risk on its own and requires special nutritional
      treatment. Currently, the main management of MAM, in Burkina Faso as in most African
      countries, consists of giving nutritional advice to the caretakers, but mothers of MAM
      children are usually given the same general dietary advice as mothers of well-nourished
      children. A more efficient, child-centred approach must be developed, by adapting the
      counselling to the needs of the family, by developing a more child-centred approach, by
      providing operational recommendations for MAM children, and by providing an adequate
      follow-up post-treatment.

      This study is thus meant to address this major gap, by testing the relative feasibility,
      effectiveness and cost-effectiveness of three innovative strategies for treating children
      with MAM: a locally produced Ready-to-Use Therapeutic Food (RUTF), an enhanced corn/soy
      blended flour (CSB++)provided by the World Food Program, and a specific and
      context-appropriate child-centred counselling.

      The evaluation will be based on a cluster-randomized trial carried out in the Houndé
      district, Burkina Faso. Eighteen rural health centres and the population living in their
      catchment area will be randomly allocated to RUSF or CSB or CCC for treating MAM. Only
      children aged 6-24 months will be included as the risk of acute malnutrition is high and more
      amenable to interventions in this age range. Overall, 2088 children with MAM will
      participate. In each study arm, children will be home-visited once a week by assessors for
      anthropometry, 24-hours recall of dietary and breastfeeding intake, and morbidity signs.
      Feeding practices will be also assessed in each arm, and the changes between baseline and
      intervention periods evaluated. Compliance will be evaluated by interviewing family members.
    

Intervention name(s): Ready-to-Use Therapeutic Food (RUTF); CBS++; CCC
Intervention type(s): Dietary Supplement; Dietary Supplement; Behavioral
Intervention description(s): A Ready-to-Use Therapeutic Food (RUTF), locally produced in Burkina Faso. The RUSF will be nutritionally characterized by chemical analysis (macronutrients, amino acids, vitamins A, C, D, E, B12, thiamin, riboflavin, niacin, calcium, iron, zinc, copper, selenium) and will be analyzed for macronutrients and energy density. All analysis methods are either based on the Official Methods of Analysis of AOAC International or in-house validated analytical methods. The pilot production phase and Hazard Analysis of Critical Control Points (HACCP) risk inventory of the production process will be performed by a food technologist from the Department of Food safety and Food quality, Ghent University.; CSB is a low-cost combination of a cereal and a legume sometimes fortified with micronutrients. However, it presents shortcomings such as too many anti-nutrients, suboptimal micronutrient content, high bulk and viscosity. The World Food Program has recently proposed an enhanced CSB, named CSB++, which is prepared from heat treated maize and de-hulled soya beans, sugar, dried skim milk, refined soya bean oil, vitamins and minerals.; Child-Centred dietary Counselling (CCC). Although educational/behavioral interventions can be effective to improve child growth, there is little evidence of their effectiveness for MAM. Moreover, evidence from Africa is inexistent. Currently, the main management of MAM consists of giving nutritional advice to the caretakers, but mothers of MAM children are given the same general dietary advice as mothers of well-nourished children. A more efficient, child-centred approach is therefore proposed, by adapting the counselling to the needs of the family, developing a more child-centred approach, by providing operational recommendations for MAM children and providing an adequate follow-up post-treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Malnutrition; Nutritional intervention; Behavioural intervention; Burkina Faso; Cluster randomize trial