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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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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00003234 |
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Date of registration:
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25/08/2011 |
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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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Effectiveness of a nutrition education intervention to improve complementary feeding practices in Malawi:
a restricted randomized trial
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Scientific title:
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Effectiveness of a nutrition education intervention to improve complementary feeding practices in Malawi:
a restricted randomized trial
- IMCF Malawi
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Date of first enrolment:
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25/08/2011 |
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Target sample size:
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2400 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00003234 |
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Study type:
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interventional |
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Study design:
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Allocation: Randomized controlled study; Masking: Open (masking not used); Control: Other; Assignment: parallel; Study design purpose: prevention
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Phase:
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N/A
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Countries of recruitment
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Malawi
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Contacts
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Name:
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Irmgard
Jordan |
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Address:
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Wilhelmstr. 20
35392
Giessen
Germany |
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Telephone:
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06419939038 |
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Email:
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Irmgard.Jordan@ernaehrung.uni-giessen.de |
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Affiliation:
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Justus-Liebig Universität Giessen |
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Name:
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Beatrice
Mtimuni |
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Address:
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P.O.Box 219
Lilongwe
Malawi |
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Telephone:
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/ |
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Email:
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bmtimuni@bunda.unima.mw |
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Affiliation:
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Bunda College of Agriculture, Department of Home Economics and Human Nutrition |
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Key inclusion & exclusion criteria
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Inclusion criteria: Households with children under two years of age
Exclusion criteria: Households with no children under two years of age
Age minimum:
0 Days
Age maximum:
23 Months
Gender:
All
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Health Condition(s) or Problem(s) studied
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Iron deficiency anaemia, unspecified
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E45
E50.9
D50.9
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Retarded development following protein-energy malnutrition
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Vitamin A deficiency, unspecified
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D50.9
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E50.9
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Intervention(s)
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Group 1: FAO/FICA implements activities to improve food security only.
Group 2: FAO/FICA implements activities to improve food security and in addition nutrition edcucation for behaviour change to improve infant and young child feeding practices.
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Primary Outcome(s)
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The Height for age Z-Score (HAZ) of children below 2 years will increase if TIPs recommendations and recipes are locally available and accepted.
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Secondary Outcome(s)
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Anemia (A) among children between 6 and 23 months, defined as hemoglobin level of < 11g/dl, will decrease by 25 %.
Retinol binding protein (RBP) levels will decrease by 15% among children with a C-reactive protein (CRP) level of < 12mg/l.
Prevalence of children with presumed acute respiratory infections and fever (ARI) and diarrhea (D) in the last two weeks prior the survey will decrease by 25%.
There will be differences in knowledge of age-appropriate complementary feeding (KCF) of children between caretakers measured using a knowledge score in interventions and controls.
TIPs formative research generates nutritionally improved, culturally acceptable and affordable recipes which result in improved feeding practices and food intake which will result in a higher dietary diversity score for the children
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Source(s) of Monetary Support
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Food and Agriculture Organization
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Ethics review
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Status: Approved
Approval date: 10/08/2011
Contact:
ethik.kommission@pharma.med.uni-giessen.de
Ethik-Kommission des Fachbereichs Medizin der Justus-Liebig-Universität Gießen
+49-641-9942470
ethik.kommission@pharma.med.uni-giessen.de
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