Joint Infant and Young Child Nutrition Program and Malnutrition Prevention

Growth Failure Clinical Trial

Official title:

Joint Infant and Young Child Nutrition Program in Burkina Faso : Impact Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02136966
• Other study ID #: IRSS0002
• Status: Completed
• Phase: N/A
• First received: May 6, 2014
• Last updated: April 12, 2016
• Start date: November 2014
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Institut de Recherche en Sciences de la Sante, Burkina Faso
• Contact: n/a
• Is FDA regulated: No
• Health authority: Burkina Faso: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Study title: Joint Infant and young children nutrition program in Burkina Faso: Impact evaluation Hypothesis: The fortification of complementary foods associated with a counseling on feeding practices for infants and young children prevents malnutrition in 6-23 months-old children.

Objective: to assess the effectiveness of a promotional care package in preventing malnutrition among children aged 6-23 months.

Description:

The 'Institut de Recherche en Sciences de la Santé (IRSS)', in collaboration with Micronutrient Initiative (MI), the Institute of Tropical Medicine (ITM) Antwerp (Belgium), and the Health District of Tougan, will conduct a study to assess the effectiveness of a promotional package in the prevention and management of malnutrition among children aged 6-23 months.

This promotional package includes:

1. A monthly follow-up sessions promoting growth in which detailed advice on feeding practices infant and young child feeding (IYCF) will be given to the mothers of children 6-23 months . These behavioral change informations be developed based on the rapid assessment of practices and foods available in the community and adaptation of the WHO manual.

2. The distribution of micronutrient powders (MNP) (15 micronutrients) to mothers of children 6-23 months of age for home fortification of complementary foods

3. Intensive counseling sessions and cooking demonstrations every two weeks for moderately malnourished children . Cooking demonstrations will include instructions on adding micronutrient powders and oil to meals .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2212
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 23 Months

Eligibility

Inclusion Criteria:

• Mothers of 6 to 23 months old children

• Reside in the study area

• Accept to use MNP

Exclusion Criteria:

• Mothers of children aged less than 6 months or more than 23 months.

• Refusal

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Failure to Thrive
• Good Infant and Young Child Feeding Practices
• Growth Failure

Intervention

Other:
• MNP + IYCN counseling + cooking demonstrations
Growth monitoring and promotion sessions will take place every month at village level for all children 0-23 months of age and will serve as an entry point for all the interventions. During these sessions children under 24 months will be weighed monthly and screened for MAM and uncomplicated SAM for treatment in the community as well as complicated SAM for referral to health facility During the monthly sessions cooking demonstrations will take place in which the community Health workers will instruct the mother how to prepare a good complementary food for 6-23 months olds adding the MNP. These meals will be given to the child during the session. Mothers will be encouraged to prepare the same meal at home During the monthly sessions enhanced IYCN counseling will be given to the mothers of 6-23 months olds, using improved BCI messages developed based on the rapid assessment of practices and foods available in the community and adaptation of the WHO manual.

Locations

Country	Name	City	State
Burkina Faso	LANOU Hermann Bienou	Ouagadougou	Kadiogo

Sponsors (4)

Lead Sponsor	Collaborator
Institut de Recherche en Sciences de la Sante, Burkina Faso	Institute of Tropical Medicine, Belgium, Micronutrient Initiative, Terre des Hommes

Country where clinical trial is conducted

Burkina Faso, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of children with adverse events as a safety measure of the use of Micronutrient Powder for food fortification at home	The morbidity will be assess every week from baseline until the end of the intervention (1 year)	1 year	Yes
Primary	Proportion of children with Weight-for-height and/or Height-for-age ZScore <-2		1 year	No
Secondary	Proportion of mothers who can describe at least 3 best practices about IYCN		3, 6 and 12 months	No