Clinical trial NCT02098031: Improving the Nutrition Status of Infants in South-Western Uganda
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Malnutrition
Nutrition Knowledge
Growth
Cognitive Development
Keywords: Child Nutrition Sciences
Growth and Development
Developing Countries
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Kyambogo University
First posted: 2014-03-27
Enrollment: 511
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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 was conducted during the period January - July 2022.


Eligibility criteria: 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

Primary outcomes:
measure: Change in the prevalence of stunting (<-2 SD of the WHO, 2006 growth reference standards)
timeFrame: 6-8, 12-16, 20-24 (main outcome time point), 36 months, 7-10 years
Secondary outcomes:
measure: Change in mean weight-for-age z-score
timeFrame: 6-8, 12-16 and 20-24, 36 months, 7-10 years
measure: Change in mean weight-for-height z-score
timeFrame: 6-8, 12-16, 20-24, 36 months, 7-10 years
measure: Change in mean Mid Upper Arm Circumference (MUAC) z-score
timeFrame: 6-8, 12-16, 20-24, 36 months, 7-10 years
measure: Change in mean diet diversification score (DDS)
timeFrame: 6-8, 12-16, 20-24, 36 months
measure: Change in Ages and Stages Questionnaire Scores (AQS)
timeFrame: 6-8, 12-16, 20-24, 36 months
measure: Change in The Kaufman Assessment Battery for Children (2nd ed.; KABC-II) and the Test of Variable of Attention (TOVA)
timeFrame: 7-10 years
measure: Change in Bayley Child Development test 3 ed.
timeFrame: 6-8, 12-16, 20-24, 36 months
measure: Change in gut microbiota
timeFrame: 20-24, 36 months, 7-10 years
measure: Change in oral microbiota
timeFrame: 36 months, 7-10 years
measure: Change in Mullens test
timeFrame: 36 months
measure: Change in Becks Depression Inventory II questionnaire to determine the maternal self-reported depression symptoms
timeFrame: 7-10 years
measure: Change in the Center for Epidemiological Studies Depression Scale questionnaires to determine the maternal self-reported depression symptoms
timeFrame: 7-10 years
measure: Oral health
timeFrame: 7-10 years
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Kyambogo University
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.