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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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4 July 2016 |
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Main ID: |
NCT02592109 |
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Date of registration:
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29/10/2015 |
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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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Effect of Enhanced Counseling Using Complementary Feeding Recommendation Based on Linear Programming on Nutritional Status,Omega-3 Fatty Acids, Malondialdehyde, and Alpha-Tocopherol in Overweight Children in East Jakarta
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Scientific title:
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Effect of Enhanced Counseling Using Complementary Feeding Recommendation Based on Linear Programming on Nutritional Status, Omega-3 Fatty Acid, Malondialdehyde, and Alpha-Tocopherol in Children With Risk of Overweight in East Jakarta |
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Date of first enrolment:
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November 2015 |
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Target sample size:
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38 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02592109 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Indonesia
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- aged 12-23 months old at first counseling
- body mass index more than +1 standard deviation in WHO Z-score
- parent agree to participate in the study by signing informed consent
Exclusion Criteria:
- Children with congenital disease and serious diseases
- Children with parent/caregiver who is illiterate
- Children with parent/caregiver who had communication disability
Age minimum:
12 Months
Age maximum:
24 Months
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Nutritional Status
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Complementary Feeding Recommendation
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Omega-3 Fatty Acids
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Alpha-Tocopherol
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Overweight
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Linear Programming,
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Malondialdehyde
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Intervention(s)
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Behavioral: Enhanced Counseling using CFR based on Linear Programming
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Primary Outcome(s)
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Nutritional status
[Time Frame: 10 weeks]
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Secondary Outcome(s)
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alpha-Tocopherol plasma
[Time Frame: 10 weeks]
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Malondialdehyde plasma
[Time Frame: 10 weeks]
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Omega-3 Fatty Acid in plasma
[Time Frame: 10 weeks]
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Secondary ID(s)
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IPermadhi
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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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