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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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10 August 2021 |
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Main ID: |
NCT03448484 |
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Date of registration:
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22/02/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Cluster Randomized, Parallel-group, Prospective, Follow-up Effectiveness Study in Kenyan Children 6-35 Months
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Scientific title:
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Programme Effectiveness of an Integrated Programme to Reduce Maternal and Child Malnutrition in Kenya: Cluster Randomized, Parallel-group, Prospective, Follow-up Effectiveness Study in Children 6-35 Months of Age at Recruitment |
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Date of first enrolment:
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March 12, 2018 |
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Target sample size:
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1927 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03448484 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Kenya
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Contacts
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Name:
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Rita Wegmüller |
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Address:
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Telephone:
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Email:
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Affiliation:
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GroundWork |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Children 6-35 months of age at recruitment
- Caregiver providing written informed consent to participate
Exclusion Criteria:
- Family does not intend to stay within the study area for at least the following 24
months
- Visible severe disease
Age minimum:
6 Months
Age maximum:
35 Months
Gender:
All
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Health Condition(s) or Problem(s) studied
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Stunting
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Intervention(s)
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Dietary Supplement: Intervention (integrated package)
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Other: Control
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Primary Outcome(s)
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Stunting and length/height-for-age z-score
[Time Frame: 2 years]
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Secondary Outcome(s)
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Nutrient density
[Time Frame: 2 years]
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Dietary diversity
[Time Frame: 2 years]
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WASH behaviour
[Time Frame: 2 years]
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Breastfeeding
[Time Frame: 2 years]
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Secondary ID(s)
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GW_1AF_KenEff_U5
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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