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Completed

NCT Number: NCT02098031

Improving the Nutrition Status of Infants 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 was conducted during the period January - July 2022.

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Key information

Age range

6 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kyambogo University

Kampala, Uganda

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Improving nutrition knowledge among mothers

Other

Primary outcomes

  1. Change in the prevalence of stunting (<-2 SD of the WHO, 2006 growth reference standards)

    Time frame: 6-8, 12-16, 20-24 (main outcome time point), 36 months, 7-10 years

    The investigators will measure the change in stunting between the three indicated time points.

Secondary outcomes

  1. Change in mean weight-for-age z-score

    Time frame: 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.

  2. Change in mean weight-for-height z-score

    Time frame: 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.

  3. Change in mean Mid Upper Arm Circumference (MUAC) z-score

    Time frame: 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.

  4. Change in mean diet diversification score (DDS)

    Time frame: 6-8, 12-16, 20-24, 36 months

    The investigators will measure the change in DDS between the three indicated time periods.

  5. Change in Ages and Stages Questionnaire Scores (AQS)

    Time frame: 6-8, 12-16, 20-24, 36 months

    The investigators will measure the change in AQS between the three indicated time periods.

  6. Change in The Kaufman Assessment Battery for Children (2nd ed.; KABC-II) and the Test of Variable of Attention (TOVA)

    Time frame: 7-10 years

    The investigators will measure the change in the scores of these tests at indicated time periods.

  7. Change in Bayley Child Development test 3 ed.

    Time frame: 6-8, 12-16, 20-24, 36 months

    The investigators will measure the change in Bayley Child Development test 3 ed. between the three indicated time periods.

  8. Change in gut microbiota

    Time frame: 20-24, 36 months, 7-10 years

    Fecal samples will be collected and the investigators will measure the change in gut microbiota between the three indicated time periods.

  9. Change in oral microbiota

    Time frame: 36 months, 7-10 years

    Saliva samples will be collected and the investigators will measure the change in oral microbiota at indicated time periods.

  10. Change in Mullens test

    Time frame: 36 months

    The investigators will measure the change in Mullens test between the two groups after 36 months.

  11. Change in Becks Depression Inventory II questionnaire to determine the maternal self-reported depression symptoms

    Time frame: 7-10 years

    The investigators will measure the change in this test between the two groups at indicated time periods

  12. Change in the Center for Epidemiological Studies Depression Scale questionnaires to determine the maternal self-reported depression symptoms

    Time frame: 7-10 years

    The investigators will measure the change in this test between the two groups at indicated time periods

  13. Oral health

    Time frame: 7-10 years

    The investigators will assay caries using photographs

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Collaborators

  • Kyambogo University

Registry information

Official study 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

Acronym: CHNUDEV

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 27, 2014
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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