Treating Moderate Malnutrition in 6-24 Months Old Children (LUCOMA)

Institute of Tropical Medicine, Belgium

Status: Completed

Conditions: Moderate Acute Malnutrition

Treatments: Dietary Supplement: CBS++; Dietary Supplement: Ready-to-Use Therapeutic Food (RUTF); Behavioral: CCC

Study type: Interventional

Funder types: Other

Identifiers

NCT01115647

ITMH0110

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,088 patients

Sex: All

Ages: 6 to 24 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,088 participants in 3 patient groups

Ready-to-Use Therapeutic Foood (RUSF)

Experimental group

Description:

Caretakers will receive weekly RUSF, 350g, and will be advised to feed it(50 g d-1 or 3 tablespoons/day) in one meal or on demand. These are pre-defined quantities. However, minimum quantities required for a timely (≤15 days) recovery from moderate malnutrition will be determined during the pilot phase. Besides supplementary food, parents will be provided with the usual nutrition counsels prevailing currently in the health services.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 assessed, and the changes between baseline and intervention periods evaluated. Compliance will be evaluated by interviewing family members.

Treatment:

Dietary Supplement: Ready-to-Use Therapeutic Food (RUTF)

CSB++

Active Comparator group

Description:

Caretakers will receive weekly CSB++ (450g) rations. Parents will be advised to feed the CSB++ (65g d-1 diluted in 370 g water) in one meal or on demand. These are pre-defined quantities. However, minimum quantities of CSB++ required for a timely (≤15 days) recovery from moderate malnutrition in the area will be determined during the pilot phase. Besides supplementary foods, parents will be provided with the usual nutrition counsels prevailing currently in the health services, i.e. to keep on breastfeeding, to increase diet diversity and to feed frequent snacks. Feeding practices will be also assessed, and the changes between baseline and intervention periods evaluated. Compliance will be evaluated by interviewing family members.

Treatment:

Dietary Supplement: CBS++

Children Centered Counseling (CCC)

Active Comparator group

Description:

The counsellor will spend 1 hour daily (during the 3 first days and then weekly) within the household for identifying enhancing and blocking factors and adapt consequently the treatment strategies in agreement with the caretakers. As in the other study arms, 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.There will be no dietary supplements intervention, outside normal practices in Burkina.

Treatment:

Behavioral: CCC