Improving the Nutrition Status of Infants in South-Western Uganda

Sponsor
University of Oslo (Other)
Overall Status
Completed
CT.gov ID
NCT02098031
Collaborator
(none)
511
1
2
29
17.6

Study Details

Study Description

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 is planned for the period January 2019 - December 2022.

Condition or Disease Intervention/Treatment Phase
  • Other: Improving nutrition knowledge among mothers
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
511 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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 Start Date :
Mar 1, 2014
Actual Primary Completion Date :
Aug 1, 2016
Actual Study Completion Date :
Aug 1, 2016

Arms and Interventions

Arm Intervention/Treatment
No Intervention: control

Experimental: intervention

Nutritional intervention (nutrition education)

Other: Improving nutrition knowledge among mothers

Outcome Measures

Primary Outcome Measures

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

  1. Change in mean weight-for-age z-score [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 [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 [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) [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) [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) [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. [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 [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 [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 [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 [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 [7-10 years]

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

  13. Oral health [7-10 years]

    The investigators will assay caries using photographs

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Months to 10 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kyambogo University Kampala Uganda

Sponsors and Collaborators

  • University of Oslo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Per Ole Iversen, MD, Professor, University of Oslo
ClinicalTrials.gov Identifier:
NCT02098031
Other Study ID Numbers:
  • 100
First Posted:
Mar 27, 2014
Last Update Posted:
Nov 29, 2019
Last Verified:
Nov 1, 2019
Keywords provided by Per Ole Iversen, MD, Professor, University of Oslo
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 29, 2019