Improving the Nutrition Status of Infants in South-Western Uganda

Study Overview
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Brief Summary
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Undernutrition and growth restriction due to poor diet and inadequate nutrient intake continues to be a global challenge, particularly in the developing countries including Uganda. The etiology of inadequate nutrient supply to infants may relate to lack of resources or knowledge or a combination of both. Poor nutrient intake and impaired growth may affect brain and cognitive development. This study aims to evaluate nutrient intake, growth and cognitive function among children between 6 and 36 months living in the fertile Kabale and Kisoro region in south-western Uganda. The investigators hypothesize that nutrition education to mothers can bring about improved dietary intake and nutritional status among children aged 6-36 months. A follow-up study is planned for the period January 2019 - December 2022.

Official Title
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Improving the Nutrition Status of 6 to 8 Months Old Children Through Diet Diversification and Better Dietary Intakes in the Kabale and Kisoro Districts in South-Western Uganda

Conditions
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Infant Malnutrition, Nutrition Knowledge, Growth, Cognitive Development

Intervention / Treatment
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* Other: Improving nutrition knowledge among mothers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A lead caretaker with a 6-8 months infant (child/lead caretaker pair) who will have given consent to participate in the study. If there is more than one child of the age in the household, the younger one will be taken as the index/study child. Exclusion Criteria: Is older than 8 months at baseline Congenital malformations or physical handicap that may influence growth or interfere with taking of anthropometric measurements Disability that will influence nutrient intake Been diagnosed with mental or brain illness as evidenced by mother or health worker. If the family that is likely to emigrate during the study period

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br> | |
| Experimental: intervention<br>Nutritional intervention (nutrition education) | Other: Improving nutrition knowledge among mothers<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the prevalence of stunting (<-2 SD of the WHO, 2006 growth reference standards) | The investigators will measure the change in stunting between the three indicated time points. | 6-8, 12-16, 20-24 (main outcome time point), 36 months, 7-10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean weight-for-age z-score | The investigators will measure the change in mean weight for age z-score between the three indicated time periods. | 6-8, 12-16 and 20-24, 36 months, 7-10 years | 
| Change in mean weight-for-height z-score | The investigators will measure the change in mean weight for height z-score between the three indicated time periods. | 6-8, 12-16, 20-24, 36 months, 7-10 years | 
| Change in mean Mid Upper Arm Circumference (MUAC) z-score | The investigators will measure the change in MUAC between the three indicated time periods. | 6-8, 12-16, 20-24, 36 months, 7-10 years | 
| Change in mean diet diversification score (DDS) | The investigators will measure the change in DDS between the three indicated time periods. | 6-8, 12-16, 20-24, 36 months | 
| Change in Ages and Stages Questionnaire Scores (AQS) | The investigators will measure the change in AQS between the three indicated time periods. | 6-8, 12-16, 20-24, 36 months | 
| Change in The Kaufman Assessment Battery for Children (2nd ed.; KABC-II) and the Test of Variable of Attention (TOVA) | The investigators will measure the change in the scores of these tests at indicated time periods. | 7-10 years | 
| Change in Bayley Child Development test 3 ed. | The investigators will measure the change in Bayley Child Development test 3 ed. between the three indicated time periods. | 6-8, 12-16, 20-24, 36 months | 
| Change in gut microbiota | Fecal samples will be collected and the investigators will measure the change in gut microbiota between the three indicated time periods. | 20-24, 36 months, 7-10 years | 
| Change in oral microbiota | Saliva samples will be collected and the investigators will measure the change in oral microbiota at indicated time periods. | 36 months, 7-10 years | 
| Change in Mullens test | The investigators will measure the change in Mullens test between the two groups after 36 months. | 36 months | 
| Change in Becks Depression Inventory II questionnaire to determine the maternal self-reported depression symptoms | The investigators will measure the change in this test between the two groups at indicated time periods | 7-10 years | 
| Change in the Center for Epidemiological Studies Depression Scale questionnaires to determine the maternal self-reported depression symptoms | The investigators will measure the change in this test between the two groups at indicated time periods | 7-10 years | 
| Oral health | The investigators will assay caries using photographs | 7-10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Child Nutrition Sciences, Growth and Development, Developing Countries