- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02098031
Improving the Nutrition Status of Infants in South-Western Uganda
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
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.
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Kampala, Uganda
- Kyambogo University
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Žádný zásah: řízení
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Experimentální: intervention
Nutritional intervention (nutrition education)
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Change in the prevalence of stunting (<-2 SD of the WHO, 2006 growth reference standards)
Časové okno: 6-8, 12-16, 20-24 (main outcome time point), 36 months, 7-10 years
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The investigators will measure the change in stunting between the three indicated time points.
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6-8, 12-16, 20-24 (main outcome time point), 36 months, 7-10 years
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Change in mean weight-for-age z-score
Časové okno: 6-8, 12-16 and 20-24, 36 months, 7-10 years
|
The investigators will measure the change in mean weight for age z-score between the three indicated time periods.
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6-8, 12-16 and 20-24, 36 months, 7-10 years
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Change in mean weight-for-height z-score
Časové okno: 6-8, 12-16, 20-24, 36 months, 7-10 years
|
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
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Change in mean Mid Upper Arm Circumference (MUAC) z-score
Časové okno: 6-8, 12-16, 20-24, 36 months, 7-10 years
|
The investigators will measure the change in MUAC between the three indicated time periods.
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6-8, 12-16, 20-24, 36 months, 7-10 years
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Change in mean diet diversification score (DDS)
Časové okno: 6-8, 12-16, 20-24, 36 months
|
The investigators will measure the change in DDS between the three indicated time periods.
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6-8, 12-16, 20-24, 36 months
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Change in Ages and Stages Questionnaire Scores (AQS)
Časové okno: 6-8, 12-16, 20-24, 36 months
|
The investigators will measure the change in AQS between the three indicated time periods.
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6-8, 12-16, 20-24, 36 months
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Change in The Kaufman Assessment Battery for Children (2nd ed.; KABC-II) and the Test of Variable of Attention (TOVA)
Časové okno: 7-10 years
|
The investigators will measure the change in the scores of these tests at indicated time periods.
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7-10 years
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Change in Bayley Child Development test 3 ed.
Časové okno: 6-8, 12-16, 20-24, 36 months
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The investigators will measure the change in Bayley Child Development test 3 ed.
between the three indicated time periods.
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6-8, 12-16, 20-24, 36 months
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Change in gut microbiota
Časové okno: 20-24, 36 months, 7-10 years
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Fecal samples will be collected and the investigators will measure the change in gut microbiota between the three indicated time periods.
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20-24, 36 months, 7-10 years
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Change in oral microbiota
Časové okno: 36 months, 7-10 years
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Saliva samples will be collected and the investigators will measure the change in oral microbiota at indicated time periods.
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36 months, 7-10 years
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Change in Mullens test
Časové okno: 36 months
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The investigators will measure the change in Mullens test between the two groups after 36 months.
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36 months
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Change in Becks Depression Inventory II questionnaire to determine the maternal self-reported depression symptoms
Časové okno: 7-10 years
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The investigators will measure the change in this test between the two groups at indicated time periods
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7-10 years
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Change in the Center for Epidemiological Studies Depression Scale questionnaires to determine the maternal self-reported depression symptoms
Časové okno: 7-10 years
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The investigators will measure the change in this test between the two groups at indicated time periods
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7-10 years
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Oral health
Časové okno: 7-10 years
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The investigators will assay caries using photographs
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7-10 years
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Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- Atukunda P, Ngari M, Chen X, Westerberg AC, Iversen PO, Muhoozi G. Longitudinal assessments of child growth: A six-year follow-up of a cluster-randomized maternal education trial. Clin Nutr. 2021 Sep;40(9):5106-5113. doi: 10.1016/j.clnu.2021.08.007. Epub 2021 Aug 20.
- Kakwangire P, Moss C, Matovu N, Atukunda P, Westerberg AC, Iversen PO, Muhoozi G. The association between dietary diversity and development among children under 24 months in rural Uganda: analysis of a cluster-randomised maternal education trial. Public Health Nutr. 2021 Sep;24(13):4286-4296. doi: 10.1017/S136898002100077X. Epub 2021 Mar 12.
- Atukunda P, Muhoozi GK, Diep LM, Berg JP, Westerberg AC, Iversen PO. The association of urine markers of iodine intake with development and growth among children in rural Uganda: a secondary analysis of a randomised education trial. Public Health Nutr. 2021 Aug;24(12):3730-3739. doi: 10.1017/S1368980020001603. Epub 2020 Jul 13.
- Atukunda P, Muhoozi GKM, van den Broek TJ, Kort R, Diep LM, Kaaya AN, Iversen PO, Westerberg AC. Child development, growth and microbiota: follow-up of a randomized education trial in Uganda. J Glob Health. 2019 Jun;9(1):010431. doi: 10.7189/jogh.09.010431.
- Muhoozi GKM, Atukunda P, Diep LM, Mwadime R, Kaaya AN, Skaare AB, Willumsen T, Westerberg AC, Iversen PO. Nutrition, hygiene, and stimulation education to improve growth, cognitive, language, and motor development among infants in Uganda: A cluster-randomized trial. Matern Child Nutr. 2018 Apr;14(2):e12527. doi: 10.1111/mcn.12527. Epub 2017 Sep 19.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
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