Moderate Acute Malnutrition
Conditions
Keywords
Malnutrition, Nutritional intervention, Behavioural intervention, Burkina Faso, Cluster randomize trial
Brief 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.
Interventions
DIETARY_SUPPLEMENTReady-to-Use Therapeutic Food (RUTF)
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.
DIETARY_SUPPLEMENTCBS++
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.
BEHAVIORALCCC
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.
Sponsors
Institut de Recherche en Sciences de la Sante, Burkina Faso
Ministry of Health, Burkina Faso
University Ghent
Institute of Tropical Medicine, Belgium
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 24 Months
Healthy volunteers
No
Inclusion criteria
* living in the catchment area of one of the 18 health centres participating in this cluster randomized trial * 6-24 months of age * -3≤ weight for height z score \<-2 without edema * No major clinical complications * Showing appetite
Exclusion criteria
* Weight-for-Height Z-score \<-3 and/or the presence of bilateral * Presence of bilateral pitting oedema * Not showing appetite
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recovery rate | One month (average) | Weight-for-Height Z-score≥-1 SD |
| Morbidity rate | One month (average) | ARI, diarrhoea, anaemia and malaria incidence. Morbidity will be assessed every week by a locally pre-tested standardized questionnaire |
| Cost-effectiveness | Twelve months | The net differential costs and key outcomes for each intervention will be used to calculate the incremental cost-effectiveness ratios, i.e. the incremental costs divided by the incremental benefits. Specific cost-utility analysis will be performed to disentangle costs of a routine program including the intervention elements from those incurred from the research activities of the project. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Default rate | 2 weeks | Patient absent or refusing food during 2 consecutive weeks |
| Satisfaction of parents and acceptability | Three months (average) | Survey to be conducted with households |
| Time to recovery | One month (average) | — |
| Retinol & soluble serum transferrin receptors (Iron markers) | Three months (average) | Retinol & soluble serum transferrin receptors (Iron markers) |
| Diet replacement & Intra-household dispatching of the food supplements | Three months (average) | Assessment with households |
| Relapse rate | Up to three months (average) | Patients representing inclusion criteria within 3 months following discharge |
| Failure rate | 8 weeks | Patients not gaining weight after 2 weeks or with a Weight-for-Height Z-score\<-1 SD after 8 weeks |
Countries
Burkina Faso
Outcome results
None listed