Malnutrition Clinical Trial
Official title:
Saving Brains In Uganda And Burkina Faso (PROMISE Saving Brains)
The study will estimate the effect of peer-counseling for exclusive breast feeding (EBF) in the first 6 months of life on cognition and other determinants of human capital formation including behavioral and emotional status; school readiness and attainment; health status; fine and gross motor skills; physical growth; and household economic status.
Status | Enrolling by invitation |
Enrollment | 600 |
Est. completion date | October 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 4 Years to 7 Years |
Eligibility |
Inclusion Criteria: - Children whose mothers participated in the original intervention of peer support for exclusive breastfeeding (EBF). - Informed caregiver consent Exclusion Criteria: |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
Uganda | Makerere University | Kampala |
Lead Sponsor | Collaborator |
---|---|
Makerere University | Centre Muraz, University of Bergen |
Uganda,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | School attainment | School attainment in the intervention compared to school attainment in the control group | One year | No |
Other | School readiness | The age at which children are ready to start school in the intervention compared to the control group. | One year | No |
Other | Physical growth | Compare the proportion of children with poor nutritional status in the intervention and control group. | One year | No |
Other | Behavioural and emotional status | Behavioral and emotional status of children in the intervention compared to those in the control group | One year | No |
Other | Household economic status | Assess the social economic status in the intervention compared to the social economic status in the control group. | One year | No |
Other | Motor skills | Compare motor skills of children in the intervention compared to the control group using MABC | One year | No |
Primary | Cognitive function | Proportion of children with impaired cognitive function in intervention compared to the control group | one year | No |
Secondary | Cost-effectiveness of promoting peer-counselling for exclusive breastfeeding in the first six months of life to support human capital formation | Determine the cost of promoting peer counselling for exclusive breastfeeding in relation to the cost of attending to children with poor outcomes | 3 months | No |
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