Trial document

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Trial Description

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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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Trial Acronym

IMCF Malawi

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URL of the Trial


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Brief Summary in Lay Language

FAO needs to document the impact of the TIPs approach, capitalise on lessons learnt and refine recommendations to inform the design of future interventions and prioritise resource allocation. However, FAO is not a research institution and has therefore asked the Justus Liebig University to evaluate their TIPs approach within ongoing FAO food security projects i.e. the FAO/FICA project in Malawi. The expected outcome is an assessment of the effectiveness of promoting locally-available and affordable complementary foods to improve infant and young children’s nutritional status based on TIPs within FAO food security projects.

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Brief Summary in Scientific Language

Malnutrition still remains one of the biggest challenges in developing countries. Children aged 0-23 months are the most vulnerable group with a peak incidence of mortality and morbidity. The promotion of a nutrient-dense diet based on locally available foods is essential to improve the nutritional status of young children.
In order to optimize infants and young children’s diets, FAO supports the formative research technique “Trials of Improved Practices (TIPs)”. TIPs helps to understand families’ preferences, capabilities as well as obstacles in improving their complementary feeding practices.
The Malawi Demographic Health Survey 2010 estimated a national stunting prevalence of 47.1%. Results show that stunting increases after six months of age when most children receive complementary feeding. FAO will therefore conduct TIPs in two districts in Malawi followed by a wider dissemination of behaviour change messages. The objective of the research is to evaluate the effectiveness of the behaviour change messages.
Prior to the TIPs, a baseline survey will assess the nutrition security situation of families with children below two years in the FAO project region. The behaviour change communication strategies identified in the TIPs process will be implemented in the prior selected intervention areas by the FAO project. A cross-sectional survey will be conducted by a research team after at least 18 months of intervention evaluating the impact of the intervention by a research team.
The primary outcome parameters to be measured will be mean Height for Age Z-Scores (HAZ). Secondary outcome parameters will be vitamin A deficiency, iron deficiency and behaviour change. Methods for data collection will include anthropometric measurements, questionnaires, collection of capillary blood, and focus group discussions. Statistical analysis will compare primarily the difference of the mean Height-for-age Z-score in intervention and control areas.

The study is related to IMCF Cambodia.

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Organizational Data

  •   DRKS00003234
  •   2011/08/25
  •   [---]*
  •   no
  •   Approved
  •   119/11, Ethik-Kommission des Fachbereichs Medizin der Justus-Liebig-Universität Gießen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   E45 -  Retarded development following protein-energy malnutrition
  •   E50.9 -  Vitamin A deficiency, unspecified
  •   D50.9 -  Iron deficiency anaemia, unspecified
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Interventions/Observational Groups

  •   FAO/FICA implements activities to improve food security only.
  •   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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  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Prevention
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

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

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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Countries of Recruitment

  •   Malawi
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Locations of Recruitment

  • [---]*
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  •   Actual
  •   2011/08/25
  •   2400
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   0   Days
  •   23   Months
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Additional Inclusion Criteria

Households with children under two years of age

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Exclusion Criteria

Households with no children under two years of age

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  • start of 1:1-Block address primary-sponsor
    • Justus-Liebig Universität Giessen
    • Mr.  Professor Dr  Michael  Krawinkel 
    • Wilhelmstr. 20
    • 35392  Giessen
    • Germany
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    • Justus-Liebig Universität Giessen
    • Ms.  Dr  Irmgard  Jordan 
    • Wilhelmstr. 20
    • 35392   Giessen
    • Germany
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    • Bunda College of Agriculture, Department of Home Economics and Human Nutrition
    • Ms.  Dr  Beatrice   Mtimuni 
    • P.O.Box 219
    • Lilongwe
    • Malawi
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Sources of Monetary or Material Support

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    • Food and Agriculture Organization
    • Viale delle Terme di Caracalla
    • 00153   Rome
    • Italy
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  •   Recruiting complete, follow-up complete
  •   2014/09/04
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.