Treating Moderate Malnutrition in 6-24 Months Old Children

NCT01115647 | Completed

• 1 other identifier: ITMH0110
• Study Type: interventional
• Target: 2,088
• Locations: 1 country
• Sites: 1

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.

Conditions

Moderate Acute Malnutrition

Keywords

Malnutrition; Nutritional intervention; Behavioural intervention; Burkina Faso; Cluster randomize trial

Outcome Measures

Primary Outcomes (3)

• Recovery rate

  Weight-for-Height Z-score≥-1 SD

  One month (average)

• Morbidity rate

  ARI, diarrhoea, anaemia and malaria incidence. Morbidity will be assessed every week by a locally pre-tested standardized questionnaire

  One month (average)

• Cost-effectiveness

  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.

  Twelve months

Secondary Outcomes (7)

• Time to recovery

  One month (average)

• Relapse rate

  Up to three months (average)

• Failure rate

  8 weeks

• Default rate

  2 weeks

• Satisfaction of parents and acceptability

  Three months (average)

Study Arms (3)

Ready-to-Use Therapeutic Foood (RUSF)

EXPERIMENTAL

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.

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

CSB++

ACTIVE COMPARATOR

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.

Dietary Supplement: CBS++

Children Centered Counseling (CCC)

ACTIVE COMPARATOR

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.

Behavioral: CCC

Interventions

Ready-to-Use Therapeutic Food (RUTF) DIETARY_SUPPLEMENT

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.

Ready-to-Use Therapeutic Foood (RUSF)

CBS++ DIETARY_SUPPLEMENT

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.

CSB++

CCC BEHAVIORAL

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.

Children Centered Counseling (CCC)

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• living in the catchment area of one of the 18 health centres participating in this cluster randomized trial
• months of age
• ≤ weight for height z score \<-2 without edema
• No major clinical complications
• Showing appetite

You may not qualify if:

• Weight-for-Height Z-score \<-3 and/or the presence of bilateral
• Presence of bilateral pitting oedema
• Not showing appetite

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead
• Institut de Recherche en Sciences de la Sante, Burkina Faso: collaborator
• Ministry of Health, Burkina Faso: collaborator
• University Ghent: collaborator

Study Sites (1)

18 Health Centres in Houndé District

Houndé, Burkina Faso

Location

Related Publications (1)

• Nikiema L, Huybregts L, Kolsteren P, Lanou H, Tiendrebeogo S, Bouckaert K, Kouanda S, Sondo B, Roberfroid D. Treating moderate acute malnutrition in first-line health services: an effectiveness cluster-randomized trial in Burkina Faso. Am J Clin Nutr. 2014 Jul;100(1):241-9. doi: 10.3945/ajcn.113.072538. Epub 2014 May 7.

  PMID: 24808482 DERIVED

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Laetitia Ouedraogo Nikiema, MD, MSc

  IRSS, Burkina Faso

  PRINCIPAL INVESTIGATOR

• Dominique Roberfroid, MD MSc MPhil

  ITM

  STUDY DIRECTOR

• Patrick Kolsteren, MD, PhD

  ITM, Antwerpen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2010
• First Posted: May 4, 2010
• Study Start: July 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: November 22, 2011

Record last verified: 2011-11

Locations

BU (1)