Improving the Nutrition Status of Infants in South-Western Uganda (CHNUDEV)

November 17, 2024 updated by: Per Ole Iversen, MD, University of Oslo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

511

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Kampala, Uganda
        • Kyambogo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 10 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
Experimental: intervention
Nutritional intervention (nutrition education)
Other: Improving nutrition knowledge among mothers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6-8, 12-16, 20-24 (main outcome time point), 36 months, 7-10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6-8, 12-16 and 20-24, 36 months, 7-10 years
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.
6-8, 12-16, 20-24, 36 months, 7-10 years
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.
6-8, 12-16, 20-24, 36 months, 7-10 years
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.
6-8, 12-16, 20-24, 36 months
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.
6-8, 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)
Time Frame: 7-10 years
The investigators will measure the change in the scores of these tests at indicated time periods.
7-10 years
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.
6-8, 12-16, 20-24, 36 months
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.
20-24, 36 months, 7-10 years
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.
36 months, 7-10 years
Change in Mullens test
Time Frame: 36 months
The investigators will measure the change in Mullens test between the two groups after 36 months.
36 months
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
7-10 years
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
7-10 years
Oral health
Time Frame: 7-10 years
The investigators will assay caries using photographs
7-10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oslo

Collaborators

Kyambogo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

March 21, 2014

First Submitted That Met QC Criteria

March 24, 2014

First Posted (Estimated)

March 27, 2014

Study Record Updates

Last Update Posted (Actual)

November 20, 2024

Last Update Submitted That Met QC Criteria

November 17, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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