NCT02136966

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,212

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 13, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 14, 2016

Status Verified

April 1, 2016

Enrollment Period

11 months

First QC Date

May 6, 2014

Last Update Submit

April 12, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Proportion of children with Weight-for-height and/or Height-for-age ZScore <-2

    1 year

Secondary Outcomes (1)

  • Proportion of mothers who can describe at least 3 best practices about IYCN

    3, 6 and 12 months

Other Outcomes (1)

  • Number of children with adverse events as a safety measure of the use of Micronutrient Powder for food fortification at home

    1 year

Study Arms (2)

Programme

EXPERIMENTAL

* Distribution of Micronutrients powders (MNP) * Intensive counseling on Infant and Young Child Nutrition * Cooking demonstrations

Other: MNP + IYCN counseling + cooking demonstrations

Controle

NO INTERVENTION

* Usual Infant growth monitoring and promotion activities * No distribution of micronutrients powders * No Intensive counseling * No cooking demonstrations

Interventions

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.

Programme

Eligibility Criteria

Age6 Months - 23 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Mothers of 6 to 23 months old children
  • Reside in the study area
  • Accept to use MNP

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LANOU Hermann Bienou

Ouagadougou, Kadiogo, Burkina Faso

Location

Related Publications (1)

  • Lanou HB, Osendarp SJM, Argaw A, De Polnay K, Ouedraogo C, Kouanda S, Kolsteren P. Micronutrient powder supplements combined with nutrition education marginally improve growth amongst children aged 6-23 months in rural Burkina Faso: A cluster randomized controlled trial. Matern Child Nutr. 2019 Oct;15(4):e12820. doi: 10.1111/mcn.12820. Epub 2019 Jun 10.

MeSH Terms

Conditions

Failure to Thrive

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hermann Lanou, MSc

    Institut de Recherche en Sciences de la Santé (IRSS), Ouagadougou, Burkina Faso

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

May 6, 2014

First Posted

May 13, 2014

Study Start

November 1, 2014

Primary Completion

October 1, 2015

Study Completion

December 1, 2015

Last Updated

April 14, 2016

Record last verified: 2016-04

Locations