Effectiveness of Child Centered Counseling on Child Nutrition Status (LUCOMAI)
Primary Purpose
Malnutrition
Status
Completed
Phase
Not Applicable
Locations
Burkina Faso
Study Type
Interventional
Intervention
Growth promotion based on child centered approach
Sponsored by
About this trial
This is an interventional prevention trial for Malnutrition focused on measuring Cluster Randomized Trial,, Nutrition counseling,, Caretaker's knowledge, Child growth,, Prevention,, Acute malnutrition
Eligibility Criteria
-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:
Sites / Locations
- Institut de Recherche en Sciences de la Santé
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Growth promotion based on child centered approach
Control
Arm Description
Outcomes
Primary Outcome Measures
Incidence of acute malnutrition
Secondary Outcome Measures
Incidence of Diarrhea, fever, Acute respiratory infection
Full Information
NCT ID
NCT01977365
First Posted
October 30, 2013
Last Updated
November 5, 2013
Sponsor
Institut de Recherche en Sciences de la Sante, Burkina Faso
Collaborators
Institute of Tropical Medicine, Belgium
1. Study Identification
Unique Protocol Identification Number
NCT01977365
Brief Title
Effectiveness of Child Centered Counseling on Child Nutrition Status
Acronym
LUCOMAI
Official Title
Effectiveness of Child Centered Counseling on Child Nutrition Status. A Cluster Randomized Trial in Rural Burkina Faso.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut de Recherche en Sciences de la Sante, Burkina Faso
Collaborators
Institute of Tropical Medicine, Belgium
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Cluster Randomized Trial,, Nutrition counseling,, Caretaker's knowledge, Child growth,, Prevention,, Acute malnutrition
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2341 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Growth promotion based on child centered approach
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Growth promotion based on child centered approach
Intervention Description
- 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.
Primary Outcome Measure Information:
Title
Incidence of acute malnutrition
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Incidence of Diarrhea, fever, Acute respiratory infection
Time Frame
18 months
Other Pre-specified Outcome Measures:
Title
incidence of exclusive breastfeeding rates
Time Frame
18 months
Title
Child dietary diversity score
Time Frame
18 months
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
-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:
Facility Information:
Facility Name
Institut de Recherche en Sciences de la Santé
City
Ouagadougou
State/Province
Kadiogo
ZIP/Postal Code
06 BP 7192
Country
Burkina Faso
12. IPD Sharing Statement
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Effectiveness of Child Centered Counseling on Child Nutrition Status
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