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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01977365
Other study ID # IRSSOOO1
Secondary ID
Status Completed
Phase N/A
First received October 30, 2013
Last updated November 5, 2013
Start date February 2009
Est. completion date March 2012

Study information

Verified date October 2013
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

Hypothesis N°1: The "children growth promotion based on approach centered on their specific needs" enhances caretakers and health workers skills, knowledge and practices on breastfeeding, complementary feeding and child care.

Hypothesis N°1: children growth promotion based on approach centered on their specific needs" approach improves children growth and health.


Recruitment information / eligibility

Status Completed
Enrollment 2341
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility -Inclusion Criteria: all women of childbearing age in the third trimester of pregnancy, living in the study area for at least one year at the time of the inclusion and who gave informed consent.

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Growth promotion based on child centered approach
- Preventive consultations will be reorganized. From the child birth, a follow-up schedule will be establish in agreement with the mother, and the subsequent appointment will be renew at each meeting. Ten contacts will be organized for children under two years. During the first year, the number of contacts will be limited to 6 at birth , 2 , 3, 4 and 9 months to complete the vaccination schedule and an additional contact at 7 months to allow monitoring during the introduction of complementary foods. Four contacts will be held for the second year to 12, 15, 18 and 24 months to monitor the transition from complementary food to the family diet. - Inclusion of Child Centered growth promotion approach. During preventive consultations, specific messages according to the child age, health and nutritional status will be developed, based on scientific evidences and adapted to the experience and knowledge of health workers.

Locations

Country Name City State
Burkina Faso Institut de Recherche en Sciences de la Santé Ouagadougou Kadiogo

Sponsors (2)

Lead Sponsor Collaborator
Institut de Recherche en Sciences de la Sante, Burkina Faso Institute of Tropical Medicine, Belgium

Country where clinical trial is conducted

Burkina Faso, 

Outcome

Type Measure Description Time frame Safety issue
Other incidence of exclusive breastfeeding rates 18 months No
Other Child dietary diversity score 18 months No
Primary Incidence of acute malnutrition 18 months No
Secondary Incidence of Diarrhea, fever, Acute respiratory infection 18 months No
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