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Improving the Nutrition Status of Infants in South-Western Uganda

Primary Purpose

Infant Malnutrition, Nutrition Knowledge, Growth

Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Improving nutrition knowledge among mothers
Sponsored by
University of Oslo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infant Malnutrition focused on measuring Child Nutrition Sciences, Growth and Development, Developing Countries

Eligibility Criteria

6 Months - 10 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Kyambogo University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control

intervention

Arm Description

Nutritional intervention (nutrition education)

Outcomes

Primary Outcome Measures

Change in the prevalence of stunting (<-2 SD of the WHO, 2006 growth reference standards)
The investigators will measure the change in stunting between the three indicated time points.

Secondary Outcome Measures

Change in mean weight-for-age z-score
The investigators will measure the change in mean weight for age z-score between the three indicated time periods.
Change in mean weight-for-height z-score
The investigators will measure the change in mean weight for height z-score between the three indicated time periods.
Change in mean Mid Upper Arm Circumference (MUAC) z-score
The investigators will measure the change in MUAC between the three indicated time periods.
Change in mean diet diversification score (DDS)
The investigators will measure the change in DDS between the three indicated time periods.
Change in Ages and Stages Questionnaire Scores (AQS)
The investigators will measure the change in AQS between the three indicated time periods.
Change in The Kaufman Assessment Battery for Children (2nd ed.; KABC-II) and the Test of Variable of Attention (TOVA)
The investigators will measure the change in the scores of these tests at indicated time periods.
Change in Bayley Child Development test 3 ed.
The investigators will measure the change in Bayley Child Development test 3 ed. between the three indicated time periods.
Change in gut microbiota
Fecal samples will be collected and the investigators will measure the change in gut microbiota between the three indicated time periods.
Change in oral microbiota
Saliva samples will be collected and the investigators will measure the change in oral microbiota at indicated time periods.
Change in Mullens test
The investigators will measure the change in Mullens test between the two groups after 36 months.
Change in Becks Depression Inventory II questionnaire to determine the maternal self-reported depression symptoms
The investigators will measure the change in this test between the two groups at indicated time periods
Change in the Center for Epidemiological Studies Depression Scale questionnaires to determine the maternal self-reported depression symptoms
The investigators will measure the change in this test between the two groups at indicated time periods
Oral health
The investigators will assay caries using photographs

Full Information

First Posted
March 21, 2014
Last Updated
November 26, 2019
Sponsor
University of Oslo
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1. Study Identification

Unique Protocol Identification Number
NCT02098031
Brief Title
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

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant Malnutrition, Nutrition Knowledge, Growth, Cognitive Development
Keywords
Child Nutrition Sciences, Growth and Development, Developing Countries

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
511 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
No Intervention
Arm Title
intervention
Arm Type
Experimental
Arm Description
Nutritional intervention (nutrition education)
Intervention Type
Other
Intervention Name(s)
Improving nutrition knowledge among mothers
Primary Outcome Measure Information:
Title
Change in the prevalence of stunting (<-2 SD of the WHO, 2006 growth reference standards)
Description
The investigators will measure the change in stunting between the three indicated time points.
Time Frame
6-8, 12-16, 20-24 (main outcome time point), 36 months, 7-10 years
Secondary Outcome Measure Information:
Title
Change in mean weight-for-age z-score
Description
The investigators will measure the change in mean weight for age z-score between the three indicated time periods.
Time Frame
6-8, 12-16 and 20-24, 36 months, 7-10 years
Title
Change in mean weight-for-height z-score
Description
The investigators will measure the change in mean weight for height z-score between the three indicated time periods.
Time Frame
6-8, 12-16, 20-24, 36 months, 7-10 years
Title
Change in mean Mid Upper Arm Circumference (MUAC) z-score
Description
The investigators will measure the change in MUAC between the three indicated time periods.
Time Frame
6-8, 12-16, 20-24, 36 months, 7-10 years
Title
Change in mean diet diversification score (DDS)
Description
The investigators will measure the change in DDS between the three indicated time periods.
Time Frame
6-8, 12-16, 20-24, 36 months
Title
Change in Ages and Stages Questionnaire Scores (AQS)
Description
The investigators will measure the change in AQS between the three indicated time periods.
Time Frame
6-8, 12-16, 20-24, 36 months
Title
Change in The Kaufman Assessment Battery for Children (2nd ed.; KABC-II) and the Test of Variable of Attention (TOVA)
Description
The investigators will measure the change in the scores of these tests at indicated time periods.
Time Frame
7-10 years
Title
Change in Bayley Child Development test 3 ed.
Description
The investigators will measure the change in Bayley Child Development test 3 ed. between the three indicated time periods.
Time Frame
6-8, 12-16, 20-24, 36 months
Title
Change in gut microbiota
Description
Fecal samples will be collected and the investigators will measure the change in gut microbiota between the three indicated time periods.
Time Frame
20-24, 36 months, 7-10 years
Title
Change in oral microbiota
Description
Saliva samples will be collected and the investigators will measure the change in oral microbiota at indicated time periods.
Time Frame
36 months, 7-10 years
Title
Change in Mullens test
Description
The investigators will measure the change in Mullens test between the two groups after 36 months.
Time Frame
36 months
Title
Change in Becks Depression Inventory II questionnaire to determine the maternal self-reported depression symptoms
Description
The investigators will measure the change in this test between the two groups at indicated time periods
Time Frame
7-10 years
Title
Change in the Center for Epidemiological Studies Depression Scale questionnaires to determine the maternal self-reported depression symptoms
Description
The investigators will measure the change in this test between the two groups at indicated time periods
Time Frame
7-10 years
Title
Oral health
Description
The investigators will assay caries using photographs
Time Frame
7-10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Kyambogo University
City
Kampala
Country
Uganda

12. IPD Sharing Statement

Citations:
PubMed Identifier
34461584
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.
Results Reference
derived
PubMed Identifier
33706831
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.
Results Reference
derived
PubMed Identifier
32654677
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.
Results Reference
derived
PubMed Identifier
31131103
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.
Results Reference
derived
PubMed Identifier
28925580
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.
Results Reference
derived

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Improving the Nutrition Status of Infants in South-Western Uganda

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