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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT02234726
Date of registration: 08/08/2014
Prospective Registration: No
Primary sponsor: Zambia Center for Applied Health Research and Development
Public title: Improving Early Childhood Development in Zambia IECDZ
Scientific title: Improving Early Childhood Development in Zambia
Date of first enrolment: August 2014
Target sample size: 526
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02234726
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Screening. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Zambia
Contacts
Name:     Davidson Hamer
Address: 
Telephone:
Email:
Affiliation:  Boston University
Key inclusion & exclusion criteria

Inclusion criteria

- Child ages 6 to 12 months at the time of intervention launch residing in the catchment
areas of the five study health facilities

- Child's mother or main caregiver must be 15 years or older

- Child's primary caregiver must be a female (because the participants in the caregiver
groups may feel uncomfortable discussing certain issues if a man is present)

Exclusion criteria

- Caregivers who are unwilling to provide informed consent

- Families that plan to move from their health center catchment zone during the twelve
month period of the study



Age minimum: 6 Months
Age maximum: 12 Months
Gender: All
Health Condition(s) or Problem(s) studied
Child Development
Stunting
Intervention(s)
Behavioral: Early Childhood Development Program
Primary Outcome(s)
Cognitive function [Time Frame: End line (after one year); Amendment: BSID-III at year two (extension) endline]
Stunting [Time Frame: One year starting with baseline (August-September 2014) and finishing with end line (September 2015); Amendment: also measured at year two (extension) endline]
Secondary Outcome(s)
Measles vaccine 2nd dose [Time Frame: End line (one year)]
Treatment of severe acute malnutrition (SAM) [Time Frame: Baseline and end line (one year)]
Caregiver awareness of child development [Time Frame: Baseline and end line (one year)]
Secondary ID(s)
GCC 0349-03
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Department for International Development, United Kingdom
Grand Challenges Canada
PATH
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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