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Clinical Trials/NCT02098031
NCT02098031
Completed
N/A

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

University of Oslo1 site in 1 country511 target enrollmentMarch 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Infant Malnutrition
Sponsor
University of Oslo
Enrollment
511
Locations
1
Primary Endpoint
Change in the prevalence of stunting (<-2 SD of the WHO, 2006 growth reference standards)
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2014
End Date
August 2016
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Per Ole Iversen, MD

Professor

University of Oslo

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

Outcomes

Primary Outcomes

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

  • Oral health(7-10 years)
  • Change in mean weight-for-age z-score(6-8, 12-16 and 20-24, 36 months, 7-10 years)
  • Change in mean weight-for-height z-score(6-8, 12-16, 20-24, 36 months, 7-10 years)
  • Change in mean diet diversification score (DDS)(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)(7-10 years)
  • Change in Bayley Child Development test 3 ed.(6-8, 12-16, 20-24, 36 months)
  • Change in gut microbiota(20-24, 36 months, 7-10 years)
  • Change in Becks Depression Inventory II questionnaire to determine the maternal self-reported depression symptoms(7-10 years)
  • Change in Mullens test(36 months)
  • Change in the Center for Epidemiological Studies Depression Scale questionnaires to determine the maternal self-reported depression symptoms(7-10 years)
  • Change in mean Mid Upper Arm Circumference (MUAC) z-score(6-8, 12-16, 20-24, 36 months, 7-10 years)
  • Change in Ages and Stages Questionnaire Scores (AQS)(6-8, 12-16, 20-24, 36 months)
  • Change in oral microbiota(36 months, 7-10 years)

Study Sites (1)

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